Welcome to the second post reflecting on the 23rd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress. In each post, I review some of the key topics covered during the conference and provide my reactions, as well as related tips and suggestions for maximizing the effectiveness of your compliance training curriculum.
This time around I delve into the ever popular (and somewhat confusing) topic of social media and, in particular, the session titled, MINI SUMMIT 5: Social Media — Auditing and Monitoring to Promote Compliance in this Rapidly Evolving Landscape.
If you attended the conference and missed this session, it’s worth the time to watch it online. And don’t be fooled by the title, the discussion wasn’t limited to auditing and monitoring. Training was mentioned early and often. Here are some of the key ideas shared during the session:
Follow the FDA (and the FTC)
The tone of the presentation, as well as the industry’s attitude towards social media, was best summarized with this quote from one speaker, “In some respects social media is heavily regulated, and … it’s the wild, wild west.” The rules and regulations are evolving and still somewhat undefined, but the risks continue to grow.
The presenters emphasized that the FDA’s regulations related to product promotion also apply to social media (staying on-label, not making unsubstantiated claims, avoiding promotional claims without risk information, etc.). The FTC has also issued a series of guidance documents on social media. Subsequently, the social media ground rules and principles established by both agencies need to be incorporated into your curriculum. Employing a continuous learning approach, with reinforcement solutions and performance tools blended into your plan, is the most effective way to ensure your team remembers and applies those rules and principles.
For example, you could deploy a foundational training module that covers your social media policy and then later follow up with a scenario-based microlearning module that specifically focuses on the proper way to respond when encountering product misinformation online. In terms of performance support, intranet banners and strategically placed posters are also a great way to consistently reinforce important tips and reminders.
Influencing the Influencers
The FTC’s guidance documents also cover the increasing use of social media influencers. According to the presenters, the FTC is particularly focused on “establishing a connection between the advertising and the influencer.” The agency has even established a preferred list of hashtags to help influencers identify themselves as paid spokespersons (#sponsored, #ad, #paid).
What does it mean for your social media training? You need to consider external as well as internal audiences, including any potential influencers involved in the promotion of your products on platforms such as Twitter and Instagram. Who is training your influencers? How often do they receive training? What form of training do they receive? How is it being tracked? You’ll sleep better if you have deployed on-going training that emphasizes compliant behavior to those in a position to influence the promotion of your products.
The Same Rules Apply to MSLs, Executives, and Outside Agencies, Too
The presenters often cited the distinction between promotional social media posts and those related to corporate communications. Each type follows a different set of rules. This difference does not depend on one’s job role, but rather the nature of the post itself. Whether an individual is part of the medical team, the C-suite, or even with an outside agency, that does not give them carte blanche to post content without regard to the rules.
Once again, it is important to evaluate your training audiences inside and outside your organization. What are the risks? Do the same risks apply across the board? Should all topics be covered at the same frequency? Are you making any risky assumptions based on job titles? Such audience/risk analysis is the starting point for effective social media training and a compliance training curriculum in general.
The More Examples, the Better
One of the more interesting comments in the session centered on the potential risks of training itself. One presenter said, “We did so much training, it actually scared the staff.” She continued by saying the training they deployed was generic in nature and lacked the specificity and examples necessary to make it stick. In her company’s case, they made the training more effective by adding examples of what employees can and can’t like or share. That’s an excellent idea that could be further enhanced by examining the training deployment calendar.
For instance, you could create a “training series” in which the foundational training establishes the “what” and “why” of your social media policy, and follow-up with microlearning, games, mini assessments and other learning nuggets that focus on specific social media examples. When training is spaced across a learner’s timeline, learning has been scientifically proven to increase and the retention of those examples will grow.
In addition, workshops and training games offer more opportunities to reinforce the good and bad of social media activity. When deployed live or virtually, the sessions foster a dialogue in which examples can be discussed and participants can cite their own examples of what they have seen online.
Summary
At the start of this mini summit, presenters referred to a quote by the former director of the Office of Prescription Drug Promotion, Tom Abrams, “It’s the message and not the medium, so we expect the same regulations to apply to social media…” Platforms will change and evolve, but the messages your learners post, like, or share need to adhere to the good foundational compliance practices the government, HCPs, and patients expect.
Thanks for reading! If you’d like to see examples of foundational or reinforcement training solutions to address the risks of tricky subjects such as social media, contact us at info@pharmacertify.com to speak to one of our compliance training specialists.
Sean Murphy Product and Marketing Manager PharmaCertify
At PharmaCertify, our mission is to help you reduce risk through better compliance training. The mission of this blog is to provide you with a continuous flow of information to assist you in doing just that. To that end, I have reviewed the agenda for the upcoming Pharmaceutical and Medical Device Ethics and Compliance Congress (October 24-25 in Washington DC) with an eye toward the sessions I believe (and hope) are most likely to offer tips and suggestions to make your training curriculum more effective.
First, a disclaimer: while I know, or at least know of, many of the conference presenters, I am not familiar with the details of their presentations, or to what level they plan to address training. That said, here are the sessions I would put at the top of the list for helping you create better compliance training.
Day 1: Monday, October 24, 2022
9:00 am, MINI SUMMIT 3: New Product Launch Compliance Playbook For anyone prepping for a product launch, this looks like a can’t miss presentation. (Coincidentally, we recently posted a “Dear Connie the Compliance Training Director” article on this blog with ideas for how to cover the topics necessary to prepare a field team for a launch.) Terra Buckley, who heads up the Compliance Advisory Services team at MedPro, will be joined by Ann Beasley, Chief Compliance Officer at Zai Laboratory. Their combined industry experience and depth of knowledge is sure to make for a session chock full of the content you need to quell the product-launch training jitters.
9:00 am, MINI SUMMIT 4: You Finished Your Risk Assessment…Now What? Practical Approaches to Making Your Results Meaningful They had me at risk assessment. As followers of this blog can attest, we at PharmaCertify are advocates for designing a training curriculum based on risk. We utilize a process we call the compliance curriculum analysis process (CCAP) to help design a targeted training plan. So, you can see why I am intrigued by the title of this session, since it aligns with our approach. Here’s hoping Christie Camelio of EQRx, Olga Zinavenka from Endo International, and BJ D’Avella, of Paul Hastings delve into the training considerations following a risk assessment.
10:00 am, MINI SUMMIT 5: Social Media — Auditing and Monitoring to Promote Compliance in this Rapidly Evolving Landscape Here’s an anecdotal side note related to social media that highlights why I think this session should be a priority for anyone looking to optimize a compliance training curriculum: I was asked to review client changes to the storyboard for our Compliant Product Promotion eLearning module. The client added a comment on the social media screen of the document noting that her company’s policy does not allow for any product-related posts, even if they are on-label and truthful. Therein lies the problem.
The rules, policies, guidance, and best practices for the use of social media in this industry are constantly changing. You need to keep abreast of those changes and regularly consider how they should be integrated into your own policies, and subsequently, your training curriculum. Stephanie Kurteff of Medicines360, Nikki Reeves from King & Spalding, and Ed Sleeper, who is with HUTCHMED, will present.
11:00 am, MINI SUMMIT 8: New and Emerging Risks for Medical Device Medical device is in the house! Settlements are on the rise for the medical device industry, and compliance professionals facing the unique risks that accompany the promotion of devices would be wise to join Beth Weinman of Ropes & Gray, Sujata Dayal from Medline Industries, and Katherine Norris of Epsilon Life Sciences for their take on the new risks. If medical devices are your focus, and you want to know what you might be missing in your curriculum, you need to attend this one.
11:00 am, MINI SUMMIT 9: Compliance & Ethics in Emerging Companies I generally find the sessions focused on the risks facing emerging companies to be among the most valuable from a training standpoint. Compliance professionals from smaller companies face the same challenges as their colleagues from larger companies, with smaller budgets and fewer resources at their disposal. If the “emerging company” shoe figuratively fits your foot, I’m confident you will find the discussion with Kevin Ma from PharmaEssentia, Kristen Oberg from Mycovia Pharmaceuticals, and David Ryan of Epizyme to be helpful, especially (fingers crossed) if they include their suggestions for building effective training with what some might consider a shoestring budget.
1:30 pm, Keynote: US HHS Office of Inspector General Update If you’ve attended this conference over the years, you won’t be surprised that I’ve added this annual session by Mary Riordan of the OIG to my list. In fact, if I was writing this post by order of priority instead of chronologically, the session would be at the top of the list. Hearing the agency’s workplan for the upcoming year is a great starting point for anyone interested in knowing what topics should be targeted for training. Make it a priority.
Stop by the PharmaCertify booth in the Exhibit Hall to see examples of how we can help you be a compliance training hero!
5:45 pm, ADJOURNMENT AND NETWORKING RECEPTION: EXHIBIT HALL It’s been years since we’ve seen you in the Exhibit Hall! Don’t worry, I blame COVID, not you. But seriously, the reception is one of the best opportunities to mingle with your peers and share success stories for building and maintaining a successful compliance program. It’s also a great time to visit the wonderful vendors and learn the ways they can help you do just that.
The PharmaCertify team will be there (we’ve even got some surprise guests this year), with demos of the foundational, reinforcement, and performance support tools to help you launch better training. Even if it’s just to say hi, stop by the booth! We’re a friendly bunch.
Day 2: Tuesday, October 25, 2022
8:00 am, MINI SUMMIT 13: General Corporate Compliance in an Early-Stage Company and Shared Learnings for Larger Companies We may have a winner for the best session name for the conference, or at least the most audience-inclusive name. I have to say I am intrigued by the idea of carrying concepts from early-stage companies over to larger companies. While some challenges and risks are shared, some faced in early stages of product development are part in parcel to the limited resources to which they have access. The panel for this session is large and wide-ranging in terms of company size. It includes Rachel Batykefer from Mallinckrodt Pharmaceuticals, David Falcone from Merz Aesthetics, Andrea Kocharyan from Flagship Pioneering, Kirt Kraeuter from Moderna, Rachel Lei of Aldevron, and Kirsten Liston from Rethink Compliance.
9:00 am, MINI SUMMIT 17: The Evolving Transparency Reporting Landscape: Changes in 2022 and Preparing for 2023 I’m thrilled to see transparency reporting on the agenda. For context, we just revised the Compliance Foundations module, Raising Awareness of Global Transparency, and I can understand why the advent of new laws around the world make this a challenging topic for training. Determining who needs to know what, about which law, can be a challenging starting point. Our module covers the general concepts from a high-level, and includes a select list of laws, both established and new. We also include PDF documents related to the other laws in a “resources” section.
Okay, back to the session. Expect Kelly Tope of Takeda and Chelsea Ott from MedPro Systems to cover the relevant regulations in detail and jumpstart your thinking toward an effective approach to transparency training.
11:00 am, MINI SUMMIT 27: Practical Guidance for Building Better Compliance Training DO NOT MISS THIS ONE! You may think I am biased because the head of PharmaCertify, Dan O’Connor, is leading the panel, but I’ve seen the presentation slides and I am quite familiar with the training samples. Trust me when I say you want to be there. Dan will be joined by Madelyn Archibald of Bioventus, Ryan Bonistalli of Ultragenyx, and Jackie Parris from Incyte, who will share their experiences in designing, developing, and deploying better compliance training.
1:30 pm, CLOSING PLENARY SESSION: US Department of Justice Keynote, FDA Keynote, and AUSA Roundtable The presentations by current and former government representatives are usually worthwhile because the presenters offer a drastically different perspective than industry professionals. The experience and insights from this group are sure to be of value as they share their expectations for an effective program, and subsequently, a training curriculum.
The Department of Justice keynote, with Fraud Section Chief Glenn Leon, the FDA keynote with Acting Director Catherine Gray, and the AUSA Roundtable with Kelly Begg Lawrence from the District of Massachusetts, Jamie Yavelberg from the Civil Division of the DOJ, and Michael Loucks, of Skadden, Arps, Slate, Meagher & Flom, (and formerly with the District of Massachusetts) should all be considered for that important viewpoint.
Day 3: Wednesday, October 26, 2022
9:15 am, Cardiac Arrest — A CEO Lessons Learned from Surviving a Five-Year Criminal Prosecution If you’re staying for Day 3, don’t be late! I’m not sure if I can make the connection to an effective training curriculum with this one, but based on this description in the agenda, it could be interesting: Howard Root, former CEO from Vascular Solutions, will share his own experience as he faced down prosecution from the Department of Justice in a whistleblower case and won.
11:25 am, Debrief, Q&A and Best Practice Sharing Jill Dailey from Incyte, Joshua Marks from Takeda, and Daniel Spicehandler of Stryker will spend the final 35 minutes of the conference summarizing the key points and best practices shared during the first two days. Plan on attending to catch up on what you may have missed from the sessions you may have missed.
Discount Registration
Although it is billed as a “hybrid” event, the 23rd Pharmaceutical and Medical Device Ethics and Compliance Congress represents the first opportunity since the pandemic began for the industry to gather in person to share experiences, best practices, tips, and suggestions for building and maintaining an effective compliance program. While PCF has made every effort to replicate the experience of a live event with recent virtual congresses, the personal interaction and information sharing that occurs during live conferences outweighs an online experience.
If you are interested in attending the conference, we can help with a “friend of faculty” discount for first-time attendees. Please contact us at info@pharmacertify.com if you’d like to take advantage of this opportunity (in-person or online) to hear industry leaders, government representatives, and leading vendors at the discounted rate!
Thanks for reading and don’t forget to visit us at the PharmaCertify booth!
The PharmaCertify team was on-site at the in-person Pharmaceutical Compliance Congress with a new, eye-catching booth design!
Live compliance conferences are back! And organizers of the 2022 Pharmaceutical Compliance Congress hit the ground running with an impressive array of industry and government speakers presenting to an audience of eager compliance professionals. The return to some sense of “normalcy” was certainly refreshing as attendees, presenters, and vendors exchanged experiences, anecdotes, and ideas for building more effective compliance programs.
After two years of virtual conferences, this one felt different in terms of content as well, with presenters and audience members discussing, and even debating a range of topics (if you were there, you know all about the discussion around the OIG Special Fraud Alert on Speaker Programs). Below are some comments that stood out in terms of industry lessons, along with my thoughts on what these lessons could mean for your curriculum as you strive to reduce risk with better compliance training.
1. The Lesson: Good enough training is not nearly good enough.
What Was Said: “Having a healthy compliance program is not enough. The Department of Justice has made it clear they expect your program to evolve.”
When It Was Said:Why and How You Can EVOLVE Your Compliance Program
What It Means for Your Curriculum: Your training curriculum must evolve with your program. In fact, the agency’s 2020 Evaluation of Corporate Compliance Programs document is clear when it calls for “more targeted training to enable employees to identify and raise issues,” and it instructs prosecutors to ask, “has the company evaluated the extent to which the training has an impact on employee behavior or operations?” So, how does a busy compliance officer demonstrate that he or she is deploying training that “has an impact on behavior?”
It begins with a continuous learning approach to your curriculum. As I have written in previous posts on this blog, the Ebbinghaus Forgetting Curve demonstrates that learners will forget up to 90% of what they have learned seven days after the event. So, if you’re not continuously evolving by deploying nuggets of compliance training, your chances of demonstrating impactful training when the regulators come calling are dangerously slim. Have you integrated microlearning covering high-risk topics into your curriculum? Are you supporting your field team with just-in-time interactive PDFs and messaging in the field when they need it most?
2. The Lesson: Medical Science Liaisons need to know more than medical affairs.
What Was Said: “Don’t assume people in medical affairs have been trained the right way.”
When It Was Said:A Look at Commercial and Medical Affairs to Understand Changes to An Organization’s Evolving Compliance Needs
What It Means for Your Curriculum: Everyone in your organization, from the top down, including the medical affairs staff, needs to be trained in the rules, polices, and nuances of compliance. Don’t make the mistake of focusing mostly on the field staff.
MSLs, for example, are trained extensively in the science associated with a company’s products and therapeutic areas. However, they need a baseline of knowledge on commercial interactions with HCPs to understand what separates their activities from those of field staff and what defines scientific exchange versus promotion. A more compliant and ethical culture is formed when MSLs and sales representatives understand what divides their roles and what they can expect of one another in their daily business activities.
3. The Lesson: Assess it, build it, test it, repeat.
What Was Said: “Your compliance program needs to be proactive and well-tested.”
When It Was Said:Keynote Enforcement Panel — Stay on the Pulse of Emerging Trends
What It Means for Your Curriculum: It’s not as much what was said, but in which session it was said, that piqued my interest. I’ve heard savvy and respected industry professionals espouse the need for a more proactive approach to compliance for years, but now the regulators have joined the “time for a change” chorus and that should be a signal to the entire industry.
A regularly scheduled curriculum analysis will help ensure your program is viewed as one that is “proactive and well-tested.” We help our clients evaluate where they are in the product development process and what training they’re already delivering on which topics, in what form, and at what frequency. Gaps and redundancies are delineated using our Compliance Curriculum Analysis Tool (CCAT), allowing for opportunities to effectively address any identified risks through a stream of continuous training. It’s a comprehensive process that often reveals surprises in terms of what is and isn’t covered sufficiently. Don’t raise your risk level by assuming you know.
4. The Lesson: Speaker programs, speaker programs, and, did I mention, speaker programs.
What Was Said: A lot, especially about alcohol (more on that later).
When It Was Said: Often, but I will focus on the Oversight and Best Practices for Speaker Programs, HCP Engagement and Sales Interaction session.
What It Means for Your Training: Where do I begin? Not surprisingly, speaker programs were an intended and unintended oft-repeated topic. In the Oversight and Best Practices for Speaker Programs, HCP Engagement and Sales Interaction presentation, presenters offered valuable tips in consideration of the regulatory focus on the programs by corporate integrity agreements and the OIG Special Fraud Alert. As an example, a significant amount of time was spent discussing the necessity for a needs assessment for each program as justification for the topic, speaker, and invitees. And, of course, meals and alcohol were addressed at length, with panelists weighing in on how their companies handle the management of both.
The advent of the pandemic and subsequently, virtual speaker programs, has led the government to raise questions about the need for live programs. And the OIG’s Special Fraud Alert clearly continues to reverberate across the bow of the industry. It’s a hot topic and diligence is needed more than ever to establish justification for the programs, as well as for training on the changing details around the programs. If you have not updated your speaker program training (for field staff as well as HCPs), the newly updated, Managing Speaker Program Risk, from our Compliance Foundations library of off-the-shelf eLearning modules, covers topics like program logistics, virtual programs, speaker criteria, attendee management, and responding to off-label questions. Just send me a note if you’d like to see a demo.
5. The Lesson: Cover the important details but don’t get caught up in the minutia.
What Was Said: “As compliance professionals, it’s a shame we have to spend so much time on whether or not alcohol should be served, when the core purpose should be that you have to run an educational event.”
When It Was Said:Chairperson’s Review of Day 1
What It Means for Your Training: If there was an unintended theme to the conference, it was alcohol (and I am not referring to any activity at the hotel bar). In light of the Special Fraud Alert and recent changes to the PhRMA Code, the presence of alcohol at speaker programs took center stage. It was discussed by presenters and audience members throughout the conference. Do you serve it? Do you allow it? Can attendees bring it in from another room? Can they leave and get a drink? Eventually, multiple presenters emphatically pointed out that attendees are much too focused on this one narrow topic and getting caught up in details like this is a waste of time and energy.
The almost obsessive attention to alcohol did lead one presenter to raise a compelling question though, “How does a company make sure important issues are addressed while not spending too much time on the logistics?” It’s a critical consideration for your curriculum as well, and the secret is in the planning. Taking the time to map your highest risks against the levels and frequency of training is the first step to ensuring that necessary topics are covered appropriately. And, just as importantly, that time and resources are not misspent obsessing over topics that don’t represent a high level of risk for your company.
6. The Lesson: It’s a small world after all.
What Was Said: “We are looking to France and other countries for ideas.”
When It Was Said:Compliance Top 10 — Clear and Concise Overview of the Top Areas of Concern for the Compliance Professional
What It Means for Your Training: If your company does business overseas, training needs to be extended and tracked to those responsible for that business, even if its solely third-party vendors. Do you understand the tenants of regulations like Loi Bertrand (French Sunshine Act) and the EFPIA Disclosure Code? Also, do your global third-party vendors have access to the same training you are utilizing for your employees? Can they access your internal learning management system? If not, you need to find a cost-effective solution like PharmaCertify’s Access LMS.
Even if your company’s business is solely based in the US, you need to have an awareness of global trends. As demonstrated in recent conferences, presenters from US agencies like the DOJ have made it clear they are partnering with other governments to investigate corruption and non-compliance. They’re identifying trends around the world and using those to inform their own activities. Are you doing the same in consideration of your program and your curriculum?
7. The Lesson: Don’t assume people know the basics.
What Was Said: “You have to remember that a lot of people there have not been with a commercial company.”
When It Was Said:Emerging and Small Company
What It Means for Your Training: No matter the size of your company or the nature of its products, an effective and proactive training curriculum begins with an analysis of who needs what training and an awareness of the topic knowledge of your audience. Does your audience have previous experience with the commercial aspects of the business? Are you hiring non-tenured employees? Do they understand the industry as a whole? These are all questions you need to consider.
For example, building a training module around field-based scenarios might seem like an instructionally sound idea in general, but if your learners have been with a pre-commercial company for most, if not all, of their careers, you may want to rethink your approach. A fundamental module covering topics such as the state of the industry, why compliance is everyone’s concern, what employees can say about products in general, and the nature of the company’s relationship with healthcare professionals will ground them in the basics they need to succeed.
8. The Lesson: A values-based approach and data-driven approach are not mutually exclusive.
What Was Said: “Do not strive to have a data-driven compliance program; strive to have a values-driven program supported by data.”
When It Was Said:CCO Innovation Panel
What It Means for Your Training: Perhaps the debate over whether a values-based approach to compliance provides the right level of data to drive an appropriate level of valuable data has reached the point at which we can acknowledge both are possible. The same holds true for training. Yes, learners want and need to know the answers and information they need to compliantly conduct their activities, (e.g., how much can they spend on meals to HCPs). However, having the data to show who has been trained on what concepts and at what frequency is necessary to demonstrate a level of adherence to compliant practices — and frankly — to help you sleep better at night.
I have written on this blog about the successful formula for compliance training: core + reinforcement + performance support = integration (C+R+PS = I). The first two components of that equation provide ample opportunities to gather the data necessary to demonstrate an effective level of training and steer future training in an even more effective direction. The third component, performance support, which includes tools such as videos on the company intranet, posters, and electronic banners, raises the awareness level of training campaigns with opportunities to communicate the intention behind the training: to foster an overall sense of “doing the right thing,” and “remembering why we are here.”
The First Step Back
Kudos to Informa and the presenters for creating a successful first step back to in-person conferences. The excitement among attendees was palpable and it extended to the exhibit hall as we enjoyed countless opportunities to showcase how we help clients build better compliance training.
If you attended the conference, Dan O’Connor and his panel of industry professionals, presented great examples of how they utilize a continuous approach to training to reduce risk. It, along with some of the other sessions, is still available for conference attendees. If you didn’t attend and would like to see the demos, contact me at smurphy@nxlevelsolutions.com to schedule a brief meeting.
Thanks for reading. I look forward to seeing you at the next conference!
“The social brain is in its natural habitat when we’re talking with someone face-to-face in real time.” Daniel Goleman Author, Psychologist, and Journalist
Welcome back to live and in-person compliance congresses!
This year’s Pharmaceutical Compliance Congress is a “hybrid event,” with the in-person conference scheduled for April 25 – 27 at the Ritz-Carlton in McLean, VA. And I am sure I speak for my fellow sponsors and vendors, as well as attendees from industry, when I say, “woot, woot!”
As much as conference organizers like Informa and PCF made every effort to replicate the live experience with their virtual conferences, networking and sharing ideas and experiences is simply more effective and rewarding in a live setting, with everyone focused on the common goal of reducing risk and building a better compliance program.
So, it is with great anticipation I offer this preview of the “in-person” agenda for PCC 2022 and highlight those sessions that look interesting from a training standpoint. After all, it’s what we do at PharmaCertify.
Day 1: Monday, April 25
9:30am – 10:00am PhRMA Update
The annual PhRMA presentation appears early on the agenda this year, and the presentation by Jim Stansel should be particularly compelling in light of recent updates to the Code and the Statement on the Application of PhRMA Code Section 2 During Emergency Periods from back in June of 2020.
The revised PhRMA Code module from PharmaCertify features a new graphic design and updated content!
I’m anxious to hear how the organization plans to incorporate the guidance on virtual interactions as the world continues to emerge from the pandemic and we return to a little less of an “emergency period.” By the way, the PharmaCertify Foundations eLearning module, The PhRMA Code, has been updated to cover the changes to the Code and the language in the Statement.
10:30am – 11:00am Building a Compliance Program and Educating Internal Stakeholders to Gain Alignment, Support and Ownership
Well, that title is a mouthful, but if anyone can handle so much content in a 30-minute session, it’s this impressive lineup of panelists. Industry leader, Terra Buckley, Vice President of Compliance Advisory Services at MedPro, is joined by Jeremy Lutsky from PhaseBio, Ann Beasely of Zai Lab, Christie Camelio from TG Therapeutics, and Emily Gainor of Ironwood Pharmaceuticals. Hopefully, they will touch on training, because if you’re going to push the envelope to build a better curriculum, you’re going to need buy-in from the C-Suite.
11:00am – 12:15pm Keynote Enforcement Panel — Stay on the Pulse of Emerging Trends
I know I sound like a broken record (I am assuming that metaphor still works since albums have made such a comeback), but do not miss the enforcement panels. Nowhere else will you hear directly from those responsible for establishing the “emerging areas of focus and recent trends in enforcement oversight,” as it is described in the agenda. No less than six government representatives, including the Assistant Director of the Consumer Protection Branch of the DOJ, will be there to offer their thoughts on their top priorities. I will be listening carefully for how those trends inform our custom and off-the-shelf training courses.
12:15pm – 1:15pm Networking Lunch
Come visit the PharmaCertify booth! Well, you may have to if the folks at Informa strategically place the food in the Exhibit Hall. But seriously, we do look forward to catching up with our existing clients and contacts and even making new connections. We’ve got new and really cool demos to share, and we even have a new theme for our booth. Just look for the compliance training heroes flying around the room (or at least flying around our booth – we’re still working on permission from the hotel to fly around the room)!
1:15pm – 3:00pm Post-Lunch Tracks
The afternoon sessions are divided into three tracks titled, Patient and Advocacy Compliance; Auditing, Monitoring and Advanced Analytics; and Digital Health for the Compliance Professional. A number of the sessions from each track look inviting from a training content standpoint. As always, I recommend teaming up to cover multiple sessions if you are attending with coworkers, or even finding a study buddy onsite (I am always willing to share notes if you want to attack this together) and devise a strategy for covering as many sessions as possible. Here are the ones that catch my “training topic relevance eye” at first glance:
1:15pm – 1:45pm Optimize Advocacy-Compliance Interactions by Minimizing Barriers and Enhancing Successful Partnerships,with Christopher Canada and Amanda Sowinski, both from Amicus Therapeutics.
2:15pm-3:00pm Spotlight on Rare Disease Compliance Risks, with Danielle Pelot from Choate, Hall & Stewart, Kelly Pitt from MorphoSys, Stephen Bychowski of Sanofi Genzyme, and Michael Hercz from Sentynl Therapeutics.
1:15pm – 1:30pm Enforcement Update, with Gustav Eyler from the DOJ
2:00pm – 2:30p Key Oversight Areas for Critical Compliance Insights from Sales to Patient Support, with Karen Lowney of SUN PHARMA, Tiffany Tang from Covis Pharma, Mark Scallon of Baker Tilly, and Brian Kasnowski from SK Life Science.
1:15pm – 1:45pm Social Media – Risks vs. Benefits, with Brian Van Hoy of G&M Health
3:30pm – 4:15pm
Following a networking break at 3:30 (during which you will, no doubt, make a beeline to the PharmaCertify booth to learn more about how we can help you be a compliance training hero), two concurrent breakout sessions both look enticing in consideration of how the topics potentially affect our clients’ training courses. So, I am going to need a note-sharing partner on these two:
Oversight and Best Practices for Speaker Programs, HCP Engagement and Sales Interactions There it is! The first appearance of that “sp” word. Actually, speaker programs are sure to be covered in an enforcement panel or two by now, but anytime I see it in the title of a session, I want to be there. It’s an ever-evolving topic and the OIG Special Fraud Alert sill reverberates through the industry and in our training programs. This is yet another panel featuring an impressive lineup, with Catherine St. John from Sanofi, Cynthia Cetani of Indivior, Rore Middleton from Blueprint Medicines and Emily Gainor of Ironwood Pharmaceuticals.
Examination and Application of Key Learnings from Industry’s Most Recent CIAs Speaking of guidance, Corporate Integrity Agreements hold the fine-print details on the topics and training requirements the government considers a priority. If you want to know where to focus your training, CIAs (and this session with Elizabeth Jobes of Amryt and Nikki Reeves of King & Spalding), are good places to start.
Day 1 closes with two more concurrent sessions, divided by company size. The Emerging and Small Company panel holds particular sway for me since so many of our clients face the challenge of building an effective curriculum with the limited resources and time restrictions inherent to smaller companies. I’ll be curious to hear how Jake DeBoever of Dermavent Sciences, Jeremy Lutzky of PhaseBio, and Hunter Murdock of Axsome Therapeutics take on these challenges.
5:00pm – 6:00pm Networking and Cocktail Reception Hopefully, this is in the Exhibit Hall, so come see us again! We’ve got giveaways you’ll really dig.
Day 2: Tuesday, April 26
The morning opens with an industry-only summit, and since I am over here on the vendor side, I am sure to be denied access at the door. And I was so prepared to write glowing reviews of everything that happens in that summit in my conference review on this blog. Are they talking about us in there?
8:45am – 9:15am Compliance Top 10 — Clear and Concise Overview of the Top Areas of Concern for the Compliance Professional
Following his review of Day 1, John Oroho, from Porzio Life Sciences, offers this enticingly titled session covering the topics that should be of primary concern to the attendees. And if they are areas of concern in general, they areas of focus for compliance training. I’ll be taking copious notes in this one.
Following a CCO Innovation Panel at Panel at 9:15, a networking break at 10:00 (meet me for coffee in the Exhibit Hall everyone!) and a session focused on monitoring at 10:30, the spotlight turns to the Former Prosecutor Spotlight (see what I did there?) featuring Rachel Honig, the former Acting U.S. Attorney’s Office for the District of New Jersey and George Varghese, of WilmerHale. As with the enforcement panels, the former prosecutor sessions offer revealing insight into the topics the industry should prioritize and those that should be a focus for training.
12:15pm – 1:55pm Lunchtime! You really need to visit the PharmaCertify booth this time because this is when I break out all the new comedy material I’ve been working on just for this conference. Here’s a small sampling: what do you call a monument of a horse with his back legs firmly on the ground? An Anti-Kickback “Statue!” Get it?! Okay, here’s another one…a chief compliance officer, a sales representative, and a former Assistant U.S. Attorney walk into a bar (and you only get to hear the punchline if you visit the booth).
1:15pm – 4:00pm Breakout Sessions
After lunch and more bad jokes, the agenda is divided into three breakout sessions. I will be focused on the session covering the previously mentioned OIG Special Fraud Alert on Speaker Programs. I’m anxious to hear what the panel of seven speakers, including Sarah Whipple of Akebia Therapeutics, Hannah Putnam of Fresenius Medical Care, Andrea Kocharyan of Zealand Pharma, Ernie Hernandez of Global Blood Therapeutics, and Averi Price of Radius Health have to say on the enduring guidance, especially regarding how it affects their training.
Since medical affairs and the sales representative/MSL dynamic is always of interest from a training standpoint, the session titled, A Look at Commercial and Medical Affairs to Understand Changes to An Organization’s Evolving Compliance Needs with David Ryan of Epizyme, Jake DeBoever of Dermavant, Amy Wilson of Esperion, and Ed Sleeper of HUTCHMED is my first choice among the 2:00pm – 2:45 breakout options.
Among the 3:15pm breakout sessions for the day, the Third-Party Risk and Oversight presentation, with Ling Zeng of Dicerna, is most interesting for me considering how often we are asked to build and deliver training to global third parties. By the way, the Access LMS from PharmaCertify is a streamlined and cost-effective platform for delivering training to those vendors who don’t have access to your enterprise LMS. Let me know if you’d like to see a demo at the conference or otherwise.
From 4:00pm – 4:45pm, you do not want to miss the breakout session, Reduce Compliance Risk Using a Continuous Learning Approach by my colleague Dan O’Connor, Ed Sleeper of HUTCHMED, Dhara Moro from Sage Therapeutics, and another player to be named later. In leading the PharmaCertify team, Dan has helped forge a new approach to compliance training, based on improving retention through continuous delivery of training assets across a learner’s timeline. I have known Ed Sleeper for many years, and his experience developing engaging compliance training brings a strong and practical perspective to the presentation. And Dhara Moro and Sage have been rolling out some of the more unique and engaging compliance training we’ve seen in the last 20 years. Trust me, this is a strong presentation, featuring experienced training professionals showcasing compelling work.
Day 3: April 27, 2022
Following an important and timely breakfast summit on Diversity, Equity, and Inclusion, John Oroho’s review of Day 2, and a Policy Reforms, Pricing Pressures and Payer Marketplace Changes Impacting the Life Sciences session with Chris Sloan and Katherine Chaurette, both of Blueprint Medicines at 9:15am, you have your final chance to visit the PharmaCertify booth in the Exhibit Hall!
The conference closes with back-to-back agency addresses with Veronika Peleshchuk Fradlin from CMS and Catherine Gray from the Office of Prescription Drug Promotion at the FDA.
Summary
This year’s Pharmaceutical Compliance Congress promises to be a special one as industry leaders, vendors, and government regulators gather face-to-face for the first time in years to share experiences, expertise, and advice on building and maintaining an effective life sciences compliance program. If you haven’t yet registered for the conference, contact me at smurphy@nxlevelsolutions.com to receive a discount on the registration fee. You don’t want to miss this one!
If you aren’t able to attend the conference, you can schedule a brief session to see examples of how we help reduce risk with better core training, reinforcement, and performance support solutions by emailing info@pharmacertify.com.
See you in Virginia and thanks for reading!
Sean Murphy PharmaCertify by NXLevel Solutions Build Better Compliance Training, with PharmaCertify®
The virtual PharmaCertify booth at the Compliance Congress featured compliance training modules and games for workshops and online use!
The Pharmaceutical Compliance Forum (PCF) understandably went virtual again for the Virtual 22nd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress. Though the lack of booth traffic that inevitably accompanies virtual conferences left the PharmaCertify team longing for the return to in-person events, this year’s presentations featured a bevy of new and compelling content from industry professionals and government regulators alike.
Here are ten takeaways to keep top of mind as you continue to plan, revise, and refine your training curriculum for the first quarter of 2022 and beyond.
The focus on speaker programs isn’t going away.
If the 2020 release of the OIG’s Special Fraud Alert related to speaker programs was a figurative shot across the bow of the life sciences industry, the updated PhRMA Code, scheduled to take effect January 2022, offers steadying guidance on the details of how to conduct more compliant programs. In the OIG Update session and across multiple mini summits involving industry leaders, the mandate was clear: speaker programs are rife with the potential for fraudulent activity and assessing program practices and the level at which you train on those practices is crucial.
Hold the third parties you use for managing speaker programs to the same standards as your internal organization.
The revised Compliance Foundations eLearning module, Managing Speaker Program Risk, is now available!
Third parties have long been a staple of emphasis at industry compliance conferences, but the increased emphasis on speaker programs highlighted in recent CIAs, the OIG’s Special Fraud Alert, and the revised PhRMA Code speaks to the need for increased scrutiny. And presenters at the conference picked up on that theme. As one presenter noted, “You need to be clear up front, when you are negotiating with third parties you expect full transparency.” And training needs to be part of that consideration from the start of the conversations. Have the vendors you’re considering instituted their own training on speaker programs? Do they need to be added to your list of learners? If yes, do they have access to your enterprise LMS or will they need to access the courses through a separate portal?
Look to the new PhRMA Code for guidance.
During the mini summit focused on the OIG Alert, PhRMA Code, and AdvaMed Code, Julie Wagner, from PhRMA, detailed the process the organization went through to plan and revamp its Code. It was clearly a thoughtful and well-planned series of steps. Other presenters throughout the conference (on the industry side as well as government representatives) emphasized the need for companies to look to the Code as a framework for how to conduct HCP interactions. The updates to the Code reflect the key takeaways from recent corporate integrity agreements as well as the challenges of conducting business in a post-pandemic world. Whether your company is a signatory or not, training on the new PhRMA Code is more critical than ever. That’s why we have rebuilt our Compliance Foundations eLearning module, The PhRMA Code, with a more intuitive interface and design, and an instructionally redesigned approach to the content. Contact us at info@pharmacertify.com to see a content outline.
Assess risk across your organization, and don’t forget your training curriculum.
I may be a bit biased since the moderator is my colleague, Dan O’Connor, but the mini summit titled, Optimize Your Compliance Training: A Practical Approach to the DOJ’s Guidance, was one of the most important of the entire conference. Dan discussed the need to assess risk according to audience, topic, format, and cadence with his panelists, Katrina Church of Bioventus, Matthew Hill of Novo Nordisk, and Karen Snyder of Ironwood Pharmaceuticals. If you’re not mapping your activities frequency against the risk associated with each of those activities, the learning will suffer, and risk will rise. All risk is not created equal, and as one presenter in the DOJ/SEC panel said, “It’s difficult to implement an effective program if you don’t know where your risks are.”
You really do want employees to speak up. So, tell them.
Self-remediation was a theme during the DOJ Keynote as panelists emphasized the importance of companies bringing issues found during their own due diligence to the attention of the agency. Doing so appears to go a long way in how the agency treats cases, especially when the companies demonstrate they are taking the necessary measures to identify the root causes of the issue and remediate them. Does your training encourage employees to speak up when they witness potential violations? Is that message pushed out in periodic scenarios as part of your on-going microlearning efforts? The compliance department can’t be everywhere at all times, so reports of violations are more likely to come from the field. Make sure your learners are well-versed in your reporting and non-retaliation policies.
Be ready for surprises when the industry shifts back to field-based interactions.
During the Chief Compliance Officer FiresideChat, one CCO touched on the need to expect surprises as the industry returns to more field-based interactions by saying, “When we get back out into the field, I’m sure there will be things we weren’t expecting.” Is your curriculum built to respond to those surprises? Have you integrated the type of learning nuggets that can be quickly modified and re-deployed as the bumps in the compliance road appear? Including such easy-to-modify components such as mini-modules, alerts, and read and signs into your curriculum creates the agility to respond rapidly before those surprises cause even more uproar.
Patient programs and third-party vendors: a risky combination.
Since the OIG requires manufacturers to take steps to exclude federally insured patients from patient assistance programs, presenters in the mini summit dedicated to patient assistance programs spent a considerable amount of time discussing the need for thorough assessments of the vendors who manage the programs. As one presenter commented, “part of that is looking at the capabilities of the vendor, what processes they have, do they have rules that align with your company’s policies and expectations, and do they have qualified and trained personnel to run these programs.” And as was highlighted, multiple vendors may be involved in different aspects of the programs. The internal and external training matrix can be complex for patient programs but identifying the appropriate level of training across all vendor personnel is the first step to ensuring continuing compliance.
Measure your company’s culture and look for opportunities to strengthen it.
One of the medical device summits featured a lively discussion of company culture as a driver for employee engagement. The conversation focused on the idea that culture is the driving force behind an organization’s approach to its business and everyone in that organization is responsible for maintaining that culture. As one presenter noted, “Culture eats strategy for lunch.” It was a refreshing twist on the rules-based vs. values-based debate and at PharmaCertify, we absolutely agree that life sciences companies need to seek out opportunities to strengthen their ethical cultures – including through training. After all its in our mission statement: helping life sciences companies strengthen their compliance cultures and reduce risk through training.
When it comes to compliance, patients are the new HCPs.
Comments from panelists in the mini summit focused on patient advocacy organizations, their growing reach, and the attention they therefore require from a compliance standpoint. Even the smaller, niche organizations have a big voice with governmental agencies, so they shouldn’t be ignored. Is your compliance program, including your training curriculum, addressing patient advocacy to the appropriate level? The risk is real and as one presenter stressed, “they are the new HCPs.”
Social influencers need to be considered.
The AUSA Roundtable session concluded with a notable discussion on the influx of social influencers and the expectation for more enforcement related to these celebrities who sometimes hold sway over the purchasing habits of the American public. A recent situation involving celebrity, Kourtney Kardashian, was cited as an example of one influencer making public comments, which led to a warning letter being issued to the company by the FDA. Kardashian made a public appearance on a popular television show, as a recognized and paid spokesperson for the product, and made false or misleading efficacy and risk claims. As trivial as the topic of social influencers may seem, they need to be properly trained and prepared to appropriately speak about products.
Summary
I have only scratched the surface of the plethora of content presented during the during the Virtual 22nd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress. As with past conferences, the depth and expansiveness of topics covered was impressive and well-suited for newcomers to the life sciences compliance industry as well as experienced veterans. There was something for everyone.
PCF, the organizers, and all the presenters deserve a hearty congratulations and kudos for such a wide-ranging and informative conference. There remains no better resource for up-to-date best practices and advice than conferences like this one. Hopefully, the pandemic will be in our proverbial rear-view mirror this time next year and we’ll meet in person for the 23rd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress and never have to deal with that “virtual” word in the title again.
Visit the PharmaCertify booth at the Pharmaceutical and Medical Device Compliance Congress to see demos of our newest modules, reinforcement programs, and games!
Here we are, over a year after Covid completely upended our lives, personally and professionally, and we are still attending compliance conferences virtually. The Pharmaceutical Compliance Forum (PCF) opted for a virtual forum for the Pharmaceutical and Medical Device Ethics and Compliance Congress again this year and a quick review of the agenda highlights the notion that no matter the format, this conference consistently presents the information any compliance professional needs to help reduce risk. Here are my pre-conference thoughts on the sessions of interest, particularly those that affect compliance training curricula.
Day 1: Tuesday, November 2, 2021
In an interesting twist on the standard agenda format, PCF opens the congress this year with a series of concurrent mini summits covering a range of topics. My standard advice applies; divide and conquer. If you’re attending with colleagues, plan to attend different presentations, then share notes. Even if you attend on your own, find a friend in one of the early networking sessions and don’t be shy about asking if they are interested in taking the same note sharing tact. It’s a veritable plethora of content to wade through…and that is definitely a good thing.
Mini Summit 1: Enforcement Action Updates
I tend to include most of the enforcement panels in these preview blog posts simply because they’re rare opportunities to hear the experiences and advice of those on the forefront of actions and settlements, including topics that trainers should be concerned about. This conference is no exception. Panelists include Assistant US Attorneys from the Eastern District of Pennsylvania and the District of Massachusetts, as well as the Assistant Director of Civil Division/Fraud Section of the Department of Justice.
Mini Summit 3: Evolutions of Investigations
The title for this one caught my eye and moved to the top of my priority list. Investigations have formed the foundation for the industry’s focus throughout the growth of the compliance industry and they certainly influence the training that has evolved from the early days of PowerPoint presentations to the multi-layered foundational and reinforcement training that is now considered the vanguard of effective eLearning.
Transition Breaks and Lunch
I include the breaks in this “must attend” list of sessions because they offer the best opportunity to interact directly with peers, vendors, and consultants. These are the people who not only provide crucial funding for the conference but also offer the products and services you need to help reduce risk and build a stronger culture of ethics and compliance. We’re here and we’re anxious to meet you. So, I invite you to check in with these critical vendors in the exhibit hall.
Mini Summit 5: DOJ/SEC FCPA Panel
Please see my thoughts on Mini Summit 1. The same apply to this session focused on the Foreign Corrupt Practices Act.
Mini Summit 7: Annual Medical Device Update
Hooray for Medical Device! It’s in the conference name and it is rightfully in the agenda. While many of the topics listed throughout the agenda apply to medical device companies, concerns and challenges unique to the industry abound. The panel includes chief compliance officers from Medtronic, ZOLL Medical, and Olympus, as well as a representative from AdvaMed and I’m looking forward to hearing how they address the issues associated with the rising number of recent medical device settlements.
Open Forum with PhRMA and AdvaMed
The Senior Assistant General Counsel for PhRMA and Vice President, Global Compliance and Governance for AdvaMed will be available in an open forum, hopefully ready and willing to take your questions. Enough said.
The Pivotal Role of CCO’s in Fostering a Strong Culture of Inclusion, Trust, and Psychological Safety
After a break, the conference switches from concurrent summits to this important and timely general session. I’m especially intrigued by the phrase “psychological safety” in the title, and I look forward to hearing whether inclusion and diversity are included in the discussion.
For the final session of the day, attendees choose one of three titles: 1. Managing Remote Teams, 2. Scope and Structure of the Compliance Function, and 3. Ethics and Compliance – The Road Ahead. To borrow a cliché, Covid has clearly changed the world and our industry for the long term. While the same core principles apply no matter how business is conducted and even how training is launched, compliance challenges shift and grow with the advent of virtual interactions. That’s why numbers 1 and 3 are of particular interest to me.
Day 2: Wednesday, November 3, 2021
Day 2 kicks off with more mini summits and interactive workshops followed by the opening plenary session at 1:00 pm.
INTERACTIVE WORKSHOP III: Hot Topics in Medical Device
Medical device is back with its own workshop and that is definitely a good thing! I look forward to hearing what topics Sujata Dayal from Medline Industries and Dana McMahon of Stryker include in their presentation and comparing the list to what we cover in our off-the-shelf and custom training solutions we provide for our medical device clients.
MINI SUMMIT 15: Optimize Your Compliance Training: A Practical Approach to the DOJ’s Guidance
I confess, since my colleague, Dan O’Connor, is the moderator on this one, I may be a bit biased. But I’ve seen the initial outline for the presentation and trust me, you don’t want to miss it. Dan, and his panel of compliance professionals will delve into the landmark guidance from the DOJ and present a practical framework for building and managing a continuous curriculum of training that will help your organization align with its principles.
MINI SUMMIT 16: Patient Assistance Programs
Speaking of hot topics! Regulators are paying attention to your patient programs, and you should be doing the same. So, you don’t want to miss this opportunity to hear Noor Haq from Amgen and Kevin Ryan from ACADIA share their experiences and tips for managing and minimizing the compliance concerns associated with PAPs. By the way, here at PharmaCertify, we’ve developed a new customizable eLearning module covering patient programs. Visit our website to see a description.
INTERACTIVE WORKSHOP 4: How to Establish Risk Tolerance in an Emerging Organization
If your company faces the challenges unique to those that fall into the emerging category, this holds the potential to be one of the most valuable sessions on the docket. Terra Buckley, who is now the Vice President of Compliance Advisory Services, is a seasoned industry professional, and frankly, one of the most dynamic presenters I have seen on all topics related to life sciences. Terra will be joined by David Ryan, Chief Compliance Officer at Epizyme.
Opening Plenary Session
Several presentations are listed as part of the plenary session that runs from 1:00 pm to the close of the day’s agenda at 5:30 pm.
Keynote: OIG Update
Following the fireside chat with Giovanni Caforio, MD, Chairman and Chief Executive Officer at Bristol Myers Squibb, Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General at OIG will deliver her annual update on the agency’s enforcement actions and workplan. It’s always a highly anticipated presentation and for good reason. Her slides and notes form a solid foundation for where companies should be focusing their efforts and their resources in the coming year.
Response to OIG Special Fraud Alert and PhRMA and AdvaMed Code Update
The conference organizers have combined these three weighty topics into one presentation, and I am anxious to hear the panel of industry professionals and representatives from PhRMA and AdvaMed delve into the important details of each one. The Fraud Alert and the updates to the two codes led to significant changes in the content for our off-the-shelf and custom training courses at PharmaCertify, and we’re developing reinforcement components like a brief explanatory video describing the PhRMA Code to roll out in conjunction with the updated foundational module.
Annual Chief Compliance Officer Fireside Chat
Day 2 ends with an impressive lineup of chief compliance officers from pharma and med device, representing companies of different sizes and therapeutic focus. Ann Beasley, from Zai Lab, Shefari Kothari from Novartis, Angela Main of Zimmer Biomet, Kristin Rand from Moderna, and Latarsha Stewart from Servier Pharmaceuticals are sure to add a compelling exclamation point to a day chock full of critical compliance experiences and advice.
Day 3: Thursday, November 4, 2021
Following the form of the first two days, Day 3 begins with a series of MINI SUMMIT 21: Interactions with Health Care Professionals
Interactions with healthcare professionals are the foundation upon which solid compliance practices, principles, and training must be established. Whether those interactions are in person or virtual, they are fraught with risk, yet when they are conducted in a compliant manner, they continue to form the core of what makes the life sciences industry what it strives to be; a noble group whose primary focus is helping its customers improve the lives of patients. That’s why I’m looking forward to hearing the best practices for those interactions espoused by a panel that includes representatives from both the pharmaceutical and medical device industries.
INTERACTIVE WORKSHOP V: Evolution of Ethics & Compliance
We have been hearing about the industry shifting away from “a culture of compliance” to an “ethics-based” approach to compliance for a few years now. While the notion is a laudable one, the practicality of that migration is more challenging in such a risk-based environment. I am eager to hear the presenters’ tips for executing that evolution, including how they carry it through to their compliance training.
MINI SUMMIT 25: Trends in FDA Advertising/Promotion Enforcement: Know the Risk Areas
Any session with “Know the Risk Areas” as part of its title gets my attention and when the focus is on advertising and promotion it’s no exception.
Closing Plenary Session
The afternoon on Day 3 includes a plenary session with a series of interviews and sessions. After a keynote interview with Tim Wright, the Chief Executive Officer from MiMedx and a fireside chat with Rady Johnson from Pfizer, Catherine Gray from the FDA presents the annual FDA Keynote. Like the OIG Update from Mary Riordan, the review of the FDA’s workplan is worthwhile and important. And the AUSA Roundtable offers another valuable view of current trends and hot topics from those on the regulatory side of the table.
Day 4: Friday, November 5, 2021
Industry Only Best Practices Think Tank
I’d like to wax poetic about this, the final session of the conference, but I remain relegated to the figurative “kids’ table” of vendors and exhibitors who can only wonder what juicy nuggets of compelling and important information those insiders are discussing behind their locked virtual walls. In the meantime, I continue to stare at my email inbox, awaiting my golden ticket. Here’s a suggestion for the PCF team: perhaps an outline of the ideas and suggestions discussed during the session could be shared with all attendees after the conference concludes.
Summary and Complimentary Conference Registration
That’s quite a bit of content for any conference, so kudos to PCF and the organizers for creating such a hefty agenda and gathering so many impressive presenters. And I’ve only scratched the surface of the list of mini summits and plenary sessions. If you’re attending the conference, I invite you to stop by the PharmaCertify booth to see demos of our newest compliance training programs, workshops, and games. You don’t want to miss our new Compliance JEOPARDY!® game, the only officially licensed one on the market!
If you haven’t yet registered, we can help! As a conference sponsor, we are offering a limited number of complimentary registrations. Just contact my colleague, Dan O’Connor, at doconnor@nxlevelsolutions.com to take advantage of the opportunity to learn from your peers and fellow compliance professionals. You don’t want to miss it.
Thanks for reading and I will see you online for the conference!
Although Informa’s virtual 2021 Compliance Congress for Specialty Products was targeted to those companies that focus on rare and orphan diseases, many of the key messages shared by the panel of industry professionals and regulators were applicable to compliance professionals from companies of all shapes and sizes.
Here are some of the key takeaways from the three-day conference, with my thoughts on what those messages mean for your compliance training program:
To say the pandemic has changed the way life sciences conducts business may be cliché, but based on the presentations in this conference as well as the Pharmaceutical Compliance Congress in April, at least some of those changes are here to stay. Change begats an increased volume of risk, and in the opening session, Keeping Up with Industry Trends — Top Compliance Concerns Facing CCOs, presenters emphasized the need for risk assessments now more than ever.
1. The current pace of change highlights the importance of risk assessment.
You need to take the same approach with your training curriculum. What are the key risk areas based on your company’s products? How often are the topics relevant to your product covered in live and online training? Are key areas addressed with reinforcement and just-in-time training? We call this process the Compliance Curriculum Analysis Process (CCAP). In fact, I wrote about how the process can improve outcomes for the publication, Life Science Compliance Update, back in 2017. Thanks to the pandemic, and increased governmental scrutiny, it’s even more relevant today.
2. Choose the right company when making a career move.
While most presentations in compliance conferences are focused on the best practices and concepts necessary to optimize a program, hearing one of the presenters stress the need to be aware of culture before joining a company was refreshing and enlightening. As the presenter pointed out, you cannot be shy about exploring whether the company makes compliance meaningful and if compliance is valued – before you accept a job offer.
Don’t forget to explore their approach to training as well. Are they regularly rolling out the kind of creative training and microlearning that helps flatten the “forgetting curve” my colleague Dan O’Connor, Erica Powers of Sage Therapeutics, and Karen Snyder of Ironwood Pharmaceuticals addressed in the Optimize Your Compliance Training: A Practical Approach to the DOJ’s Guidance session? (By the way, you really should see the slides from that presentation and the examples of fun an innovative training your peers are using to help reduce risk. Drop me an email at smurphy@nxlevelsolutions.com if you’re interested.)
3.Equip leaders with consistent and proper messaging.
In a twist on the familiar “tone-from-top” mantra, another presenter in the opening CCO session stressed the need for the compliance department to take the lead in providing leadership with the proper messaging needed to reinforce that tone. As he said, “consistency is key as you cascade communication across your program.” It applies to training as well. Not only does the C-Suite need to be trained in the same concepts and policies as employees, they, and the management team, need to be repeatedly reminded of the need for a seamless message. As we’ve been told in just about every conference over the last five years, you need to earn a “seat at the table” with leadership. Once you’re in that proverbial seat, helping them espouse the messaging necessary to keep your program consistent is the key to keeping it meaningful.
4. Don’t decline meetings during the pandemic.
During the Compliance During a Pandemic session, presenters spoke at length about the importance of open lines of communication and the need to make every attempt to meet with business colleagues whenever possible. The businesses and field employees need to know you are accessible when they have questions. As another presenter chimed in, “you need to constantly make sure they know who to go to.” That concept extends to your training curriculum. Does your training include surveys and other feedback mechanisms? Do you encourage outreach in your eLearning? Creating and nurturing an open dialogue can only make your training more effective, during the pandemic and beyond.
5. If you’re going to have live speaker programs, you need to be wary of red flags.
That’s according to one presenter during the prosecutors’ presentation on high-priority risk areas. As he put it, the very fact that HHS even issued the Special Fraud Alert on Speaker Programs should be interpreted as a warning. While multiple presenters in other sessions suggested their companies will move to hybrid models with virtual and live programs, the opinions of the prosecutors were clear: expect the OIG’s focus to be on the live versions.
Managing Speaker Program Risk is one of the newly updated Compliance Foundations eLearning modules available from PharmaCertify. It covers the critical content your reps need to understand to remain in compliance, and like all our modules, it’s easily customized with your policies and content! Contact me to see a demo.
6. Not every patient advocacy organization is the size of the American Diabetes Association.
Day 2 kicked off with the Optimize and Mitigate Risk within Patient Interactions and Support Programs. Presenters noted the trickiness in dealing with advocacy groups in particular – not all the groups will be large and experienced enough to understand the potential pitfalls of compliance. You may need to educate them on the guidelines and principles, and that can be a challenge, especially on the delivery front since outside learners often don’t have access to your internal learning management system.
PharmaCertify can help with the Access LMS platform. Access LMS is a cloud-based, affordable alternative for reaching outside vendors and organizations with your compliance training. It’s simple, it’s easy-to-use, and it won’t break your budget. Contact my colleague, Dan O’Connor, at doconnor@nxlevelsolutions.com to see a demo.
7. Dig deep into the weeds with MSL/commercial training.
The relationship between the medical and commercial divisions is nuanced and fraught with risk. During the Compliant Frameworks for Medical Affairs and Commercial Interactions session, a presenter whose company recently launched its first product reinforced the need for detail. While medical/commercial interactions have always been a pain point for her, she clarifies gray areas on topics such as “the rules for visiting HCPs together,” with what she calls “ways of working documents that clarify what each group can do and why.
At PharmaCertify, we take the same approach with our MSLs and Sales Reps: Understanding the Divide Compliance Foundations module. The content is designed to cover each role in a manner that helps reps and MSLs understand their own rules as well as those of the other group. I’d be happy to send you a content outline.
8.Follow the money. The prosecutors are.
It’s no secret that the government is scouring Open Payments data. And they are following the trail of money flowing to HCPs. During the enforcement panel, one prosecutor bluntly stated, “if you pay a provider hundreds of thousands of dollars, we are going to be looking at it.”
Reps need to consistently be reminded of HCP spend limits and incorporating microlearning components like on-going assessments and quizzes into your curriculum is key to ensuring those numbers are top of mind. We’d welcome the opportunity to show you how it works.
Summary
Kudos to Informa and all presenters for putting forth a valuable and important learning experience despite the challenges that always accompany a virtual event. The pandemic has changed the way in which we share ideas, best practices, and personal experiences as much as it has changed the industry in general. As the world inches back to a more “normal” approach to information sharing, I anxiously await the day when we can again meet in person in a conference exhibit hall and exchange ideas for how you can reduce risk and build a stronger ethical culture through training.
In what could be Informa’s final “virtual” compliance congress (fingers crossed), the spring kickoff Pharmaceutical Compliance Congress offers a plethora (sweet…I got to use “plethora!”) of industry leaders and government representatives covering oft discussed, yet still relevant topics, mixed with new and timely entries to the agenda (e.g., transparency tips for 2021, advancing virtual interactions, applying behavioral science to drive an ethical culture).
From a compliance training standpoint, the general sessions and breakout workshops at PCC offer attendees the rare opportunity to evaluate their own programs and curricula against the industry standards espoused by the well-known panelists and presenters. The bottom line: if you want to keep up with your peers, you really should try to be there. We can help make that happen with a sponsor discount on the regular registration rate. Just email me for the details, get yourself registered, and get ready to soak up three days of the information you need to keep your training meaningful.
I’ve perused the conference agenda with an eye toward what each session could mean for you in general and for your 2021 training plan and here are a few of the sessions that jump off the screen:
Day 1: Tuesday, April 27
Refill your coffee cup before 10:15 am, and make sure the rest of your morning/early afternoon calendar is clear because after the chairperson’s welcome, Informa comes out of the gate swinging with three general sessions sure to have you glued to your computer screen.
The fun begins at 10:50 with James Stansel, Executive Vice President, General Counsel and Corporate Secretary at PhRMA presenting the Current Snapshot of Affairs Coming Off an Unprecedented and Politically Charged Year. Could there be a more aptly titled presentation to kick off a life sciences compliance conference after what we went though over the last 12 months?
The content you really don’t want to miss starts flowing with the Fireside Chat with CCOs – Top 10 Items on Their Radar and Why They Should Be on Yours presentation from 11:00 – 12:00. Who doesn’t love a good top ten list? (except of course David Letterman since we are just “borrowing” the concept from him.) Other than maybe “best one hit wonder music acts,” I can’t think of a topic sure to have the audience around the virtual office water cooler buzzing for weeks to follow. And, let’s face it, once someone mentions Come on Eileen by Dexys Midnight Runners, the one hit wonder list just runs out of staying power, while that OIG Speaker Programs Fraud Alert is going to be on the industry’s mind for months to follow. Toora loora toora loo rye ay!
We break for lunch at 12:00 – but as importantly, you have plenty of time to visit the virtual Exhibit Hall and learn about the various products and services available from the vendors. We’ll be at the PharmaCertify booth with demos of our newest eLearning modules and other training tools to help you manage your company’s risk and build a stronger culture of ethics and compliance. We’re creating some cool (and effective) stuff that you really need to see. I implore you…come see us lonely vendors!
File the third general session, the Keynote Enforcement Panel, in the “oft discussed but still quite relevant” category. The panelists here represent the metaphorical heart of the PCC batting order, with an acting U.S. Attorney and a First Assistant U.S. Attorney being joined by a representative of the DOJ and another from a private law firm to hold court (okay, am I pushing the euphemisms too far?) over the audience with the latest list of topics expected to be at the forefront of enforcement this year.
At 3:00 pm on Day 1, the agenda is divided into four simultaneous working groups. All of them look compelling for different reasons, but if transparency training is on your 2021 radar, I suggest Trends from 2020 Transparency Reporting and Tips for 2021 with Terra Buckley and Chelsea Ott, both of Medpro Advisory Services. Terra is one of the best industry presenters I have heard on the life sciences compliance circuit and her recent move to head up the advisory services for Medpro is quite a coup for the company and quite a bonus for its clients. Terra knows the ins and outs of transparency (and all things compliance, for that matter) and she is sure to leave you with actionable suggestions for optimizing your program.
At the same time, I can make an equally compelling case for the Advancing Digital and Virtual Interactions session, or the Optimizing Compliant Patient Interactions session based on recent headlines and settlements as well as the compliance star-studded panel scheduled for each one. Since the sessions are simultaneous, teaming up with colleagues and taking copious notes to share later is your best option to ensure appropriate coverage. That’s my plan, and if you’re looking for a “study buddy,” I’m happy to join forces. Don’t be shy, call me!
Day 2: Wednesday, April 28
After the annual year in review video presentation, the OIG fraud alert makes its first scheduled appearance at 10:30 on Day 2 with the Analysis of OIG Special Fraud Alert on Speaker Programs and Assessment of Future Activities. Considering the buzz it has stirred up in the industry since its release, don’t expect this to be the first, or final, reference to the document during the conference. The FDA Office of Prescription Drug Promotion (OPDP) and Center for Medicare and Medicaid (CMS) will follow at 11:05 and 11:35 respectively, in two sessions that typically prove to be helpful peaks into each agency’s workplan and focal points for the upcoming year.
Then at 12:00, it’s back to the Exhibit Hall. We’ll be waiting in case you didn’t get the chance to stop by on Day 1. After all, look at this top-notch lineup of sponsors and exhibitors ready to hear about your challenges and help you meet you goals!
During the afternoon, the 1:40 session, titled, Former Prosecutor Panel – Answers and Insights from Industry’s Trusted Advisors should offer insight, tips, and suggestions from a panel with unique insight into both sides of the regulatory table. And the CCO & GC Luminary Panel – Leading Strategies to Advance the Business and Accelerate Innovation, scheduled for 3:00, features a list of well-known and respected professionals, including Beth Holly from Regeneron.
At 4:00, attendees again break into one of four simultaneous “roundtable exchanges” to end the day. Depending on your priorities and business profile, you may not want to miss Table Talk A, Speaker Programs or Table Talk B, Insights for Emerging and Newly Commercial Companies, but I would be remiss to not recommend Table Talk D, Creative Compliance Training Solutions. My colleague, Dan O’Connor, will be joined by Jackie Parris of Incyte and Jen Anderson of Vertex to delve into how each company is using innovative training solutions to reduce risk across their companies. You don’t want to miss the demos in this one, so remember to “divide and conquer” across all the sessions if necessary.
Day 3: Thursday, April 29
The final day of the conference features a global tilt, beginning with the IFPMA Spotlight – Deep Dive into Evolving International Best Practices at 9:30, followed by Global Payments and FMV at 10:05, and the EU e-Privacy Directive and the Impact on Monitoring Digital Communications and Social Channels (that one is a mouthful, isn’t it?) at 10:40. Whether your company has a global footprint or not, the life sciences world is a small one and we’ve come a long way since the days of the FCPA being the primary driver of worldwide regulation, best practices, and ultimately, your training curriculum.
The day ends with a one-hour Diversity and Inclusion Summit at 12:00. It’s a timely and important (if not long overdue) way to close the conference and I will be listening for ideas on how the panelists integrate diversity concepts and messaging into their compliance training.
Summary
Hopefully, the next time I write a compliance congress preview (Informa or PCF), it will be in anticipation of an upcoming live conference. As much as I appreciate the efforts of conference organizers to replicate the live experience virtually, frankly it can’t match the value of gathering in-person. For vendors and industry attendees alike, nothing replaces the insight available through face-to-face interactions.
That being said, Informa has created a compelling agenda for this year’s virtual version of the Pharmaceutical Compliance Congress with sessions applicable to both the new and seasoned life sciences compliance professional. Opportunities, such as this, to hear from esteemed leaders in the field and regulators are rare, and anyone interested in hearing up-to-date data, tips, and suggestions for modernizing and maintaining an effective compliance program should make every effort to attend. Again, we can help with that.
Thanks for reading. I will see you online at the Congress!
The Pharmaceutical Compliance Forum (PCF) went to great lengths to replicate the experience of a live conference in this year’s virtual Pharmaceutical and Medical Device Ethics and Compliance Congress. The virtual conference platform featured presentation rooms and realistic exhibit halls that made navigating the user interface simple and logical.
Organizers took advantage of the virtual nature of the conference to maximize the amount of content available through live presentations, along with a plethora of recorded presentations available for viewing any time. In fact, if you attended the conference, the sessions will remain available to you for up to six months – so don’t be shy about logging back in and catching up on what you missed.
I’ve done just that over the last few weeks and in the spirit of the PharmaCertify mission to help you reduce risk and strengthen the compliance culture in your company, here are ten key conference takeaways to help you build a more effective training curriculum.
Meals, meals, meals.
How to handle meals during the pandemic (in speaker programs and otherwise) continues to be a common refrain during conferences. Speakers from the pharmaceutical and medical device industries touched on the topic, with the conversation mostly focused on the importance of sending meals only to HCPs’ offices and hospitals, and not to their homes. PhRMA’s guidance released earlier this year is a good starting point for updating policies and building new training: https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA-Code-Section-2.pdf. Clearly if you have not addressed the way in which meals should be provided in your policies and subsequently in your training, you should.
Remember the changes to the Sunshine Act.
Speaking of updates, attendees were reminded that the changes to the Sunshine Act go into effect in January. If your core Sunshine Act training hasn’t been updated, you need to make your learners aware of the changes in the list of covered recipients and the nature of payment categories…quickly!
Be aggressive.
Throughout the conference, government regulators agreed that they tend to view companies that have a robust compliance program more favorably during investigations. Or, as one panelist in the AUSA Roundtable put it, “if you’ve properly dealt with the problem, we’re probably going to go away.” That extends to your compliance curriculum. So not only is a “check the box” approach to training a bad idea in terms of learning, it also isn’t going to impress regulators when they come calling. A modern and effective curriculum needs to be evaluated against your company’s risk, and it needs to be supplemented with regular nuggets of training spread across the learner’s timeline.
Keep the communication flowing.
An effective curriculum doesn’t end with the deployment of training. The importance of on-going communication during the pandemic was reiterated in multiple sessions throughout the conference. Presenters focused on how the sudden shift in the way business is conducted has forced them to think about how they stay in touch with leadership and the field. The need to think differently has clearly given birth to ideas and best practices that will continue post-pandemic. Whether designating “compliance liaisons” from the businesses to bring ideas and questions back from the field, or rotating people from the businesses through the compliance department, presenters are finding creative methods to ensure compliance stays top of mind for the long term.
Patient support and speaker programs are still in focus.
Gregory Demske and Mary Riordan reminded attendees that the OIG’s focus is still squarely on patient support programs and speaker programs. And interestingly, Demske encouraged viewers to ask themselves if they really need to go back to in-person speaker programs after the pandemic and warned that the agency is going to continue to look carefully at “payments to prescribers that are under the guise of speaker programs.” Recent CIAs focused on speaker programs and patient support programs are a good starting point as you evaluate your training plan.
Pay attention to social media.
According to presenters in the social media mini summit, 70-80% of patients get information from online resources. While that’s not a surprising number in our digital age, it’s concerning in light of the dearth of guidance from federal agencies. Presenters emphasized the need to stay abreast of the emerging social media platforms and evaluate training plans in context of the limited social media guidance that is available. And the risks of social media aren’t limited to the pharmaceutical industry. In the Medical Device Roundtable session, one presenter warned that cutting-edge technology often can lead to representatives being overly enthusiastic on social media. It’s a scary, changing world online, and as a compliance professional, you need to be continually addressing it in targeted training.
Customize training for company-specific risk.
I may be biased, but the discussion about the risk-frequency framework by Dan O’Connor in the State-of-the-Art Compliance Training mini summit is “can’t miss” conference viewing. If you did miss it, let me know, and I will be happy to coordinate a brief review of the concept with Dan. The framework is a great starting point for evaluating the appropriate mix of training based on the riskiness of the activity and the frequency at which that activity occurs. Ours is not a one-style-of-training fits all world and the framework is a good way to look at your curriculum and make adjustments in the tools and techniques to address risk accordingly.
Emphasize a culture of integrity, not just compliance.
Those of us who have been working in life sciences compliance for a long time know the industry has been touting the need to shift away from a rules-based approach to compliance to one based on values and ethics. That shift is in process and was best summarized by a presenter in the Integrating Ethics and Compliance session when she said she finds the word “compliance” to be limiting and she prefers the word “integrity” to emphasize that how one does something is as important as what someone does. Or, as another presenter in the same session said, “now is the time to create a culture where people are comfortable speaking up.” That’s the language of a values-based approach and it certainly seems like it’s here to stay. Does your training incorporate these themes?
The core rules still apply.
While COVID-19 has changed the way in which business is conducted and how interactions occur, the core principles of compliance still apply. In fact, as multiple regulators and industry professionals were quick to note, “COVID is not an excuse for non-compliance.” Some of the details may have changed, but speaker programs need to be monitored, speakers need to be trained, reps need to stay on-label, federal regulations still apply, and state disclosure laws need to be followed.
More risk is okay if you have a strong foundation to manage that risk.
Many years ago, when I started working in compliance training, I could not have imagined someone being bold enough to publicly say more risk is okay. But there I was in the CCO Fireside Chat, when I heard a presenter confidently say, “striking a balance between the legal environment and business goals is key.” To my surprise, he followed up by saying, “and to help the business be more risk tolerant you need training that is sticky and impactful.” The assessment is an honest and refreshing one, and hearing the word “sticky” used in reference to compliance training brings music to the ears of someone who has been part of a team encouraging the industry to do that for 15 years. The future may be filled with more engaging and dynamic training after all.
Part 2: A Continued Focus on Speaker Programs and Patient Support Programs
This is the second in a series delving into compliance training lessons learned at the 2020 Virtual Pharmaceutical Compliance Congress. Before the sudden changes brought on by COVID-19, speaker programs and patient support programs were two of the hottest topics in the industry and the pandemic has only heightened the concern. Through live presentations and on-demand sessions available throughout the conference, regulatory officials and industry representatives offered suggestions for managing the programs.
Speaker Programs
During the Enforcement Deep Dive and the DOJ and SEC Insights sessions, panelists reviewed the recent settlements and CIAs related to speaker programs. The cases mostly focused on what one presenter referred to as the “hallmark red flags” he and his colleagues look for in an investigation: repeat speakers and attendees, speakers who were high-prescribing HCPs, alcohol being served, and less than adequate attendance. Alleged violations in the settlements were based on everything from the inappropriate fees paid to speakers and improper promotional activities at the programs, to some companies paying speakers for programs that never occurred.
While regulators provided the groundwork related to traditional topics like speaker criteria and compensation, and attendee management, industry professionals shared tips for effectively managing the programs during a pandemic. In the session titled, Operational Considerations for Speaker Programs During a Pandemic, presenters offered a list of considerations such as updating training on tracking and reporting attendance; adding up to an hour of prep time so all participants have the opportunity to get comfortable with using the technology; and reviewing existing HCP contracts and adjusting provisions for travel since travel to the programs is not currently required.
Not surprisingly, the practicality of providing meals during the pandemic was raised throughout the conference. During the DOJ Enforcement Trends Related to Speaker Programs on-demand session, the challenges with documenting and tracking consumption were raised as a unique risk associated with virtual programs. For example, “ensuring attendees stay for the educational component of a program,” and “providing meals in a way that accounts for COVID-19 related health and safety issues” are suddenly necessary considerations.
Virtual speaker programs raise challenges the industry has not had to consider before the pandemic. Presenters offered an important reminder as to why diligence to how these programs are executed is more critical than ever, by reminding the audience that “government agencies have made it clear they will scrutinize conduct…companies should still comply with codes of conduct and government regulations. There is no COVID-19 defense.”
Patient Support Programs
On the patient support program front, the emphasis in investigations is on what one presenter called “good evidence of bad motivation.” As with speaker programs, the fundamental rules continue to apply. For example, the programs cannot be used to influence a provider’s or patient’s medical decisions and patient privacy must always be protected. Grants and donations to foundations cannot be driven by sales and marketing, or as one presenter put it, “the commercial side should never determine how much goes to foundations.”
With patient foundations being a focus in recent CIAs, presenters during the Enforcement Snapshot and Best Practices Related to PAPs, Coupons and Foundations session covered the important requirements established in those settlements, including the need for a governance committee that is solely responsible for activities related to copay foundations; the importance of establishing an annual budget for donations to foundations; the requirement that donations must be selected using a risk-based approach and random sampling; and the need to be aware of state limitations on copay assistance, such as Massachusetts and California not permitting assistance when a generic is available.
Presenters also pointed out that settlements involving patient support programs have changed for one significant reason: the foundations have also been targeted and have entered into agreements with the government. As one presenter put it, “that means the foundations have skin in the game. Gone are the days when manufacturers called all the shots around contributions to foundations, program design, and compliance controls.”
The requirements detailed in recent settlements point to the need for updated policies and practices, and subsequently, updated training around patient support programs. Not only does core training need to be modified, a new approach is needed to ensure pull through on the significant changes.
A New Approach to Training
Clearly, the fundamental rules related to speaker programs and patient support programs have not changed and still need to be addressed in training, as they were before the onset of the pandemic. speaker programs and patient support programs continue to be high-risk activities. When they are not managed properly, companies face the potential for off-label promotion, false claims, and Anti-Kickback Statute violations, to name just a few. But the nuances of how these programs are executed are now in flux and require serious consideration in terms of content updates and delivery modalities.
Foundational training remains an important starting point. Dedicated training on speaker programs should still include core topics such as program logistics, audience requirements, speaker compensation and training, and answering off-label questions. And patient support program courses must continue to focus on areas such as protecting patient privacy, working with vendors, and working with patient assistance foundations.
Clearly, COVID-19 requires changes to how both types of programs are planned and executed. To ensure targeted employees stay in compliance a supplemental approach towards reinforcement may be appropriate. For example, mini modules covering the provision of meals should be considered to stress the details of updated policies. In addition, microlearning components in the form of mini-assessments, videos, and podcasts are a valuable way to increase the retention of new and updated policies as well as the foundational topics. And custom scenario-based training is an ideal format for highlighting aspects of policies that are particularly relevant to conducting these programs during the pandemic.
Increasing the retention of compliance training is more challenging than ever given the changes in which your field staff and other employees conduct business. The information shared during the Pharmaceutical Compliance Conference serves as a reminder that speaker programs and patient support programs continue to be high areas for risk and a focus of investigations. The onset of COVID-19 has complicated that risk by forcing the industry to rethink how the programs are managed and how employees are trained on the details. Creating a continuous training curriculum, with new microlearning components integrated across learners’ timelines, is critically important to ensuring those details are not lost while understanding that the potential for violations are increased.
Thanks for reading!
Sean Murphy
PharmaCertify By NXLevel Solutions
Up Next: Enhancing Training Engagement in a Changing Industry and World
In what could be Informa’s final “virtual” compliance congress (fingers crossed), the spring kickoff 
Compliance Training Intelligence 