Dear Connie the Compliance Training Director Returns!

Great news! Connie the Compliance Training Director has emerged from her self-imposed quarantine and returned to the North American Headquarters of PharmaCertify. For her first post-pandemic post, Connie answers a question about the appropriate compliance training mix for product launch…

Dear Connie,

Connie the Compliance Training Director

I’ve read the recent post on this blog about the formula for a better compliance training curriculum, and I completely agree with the rationale for a combination of foundational training, reinforcement, and performance support. I am a compliance officer for a pharmaceutical company in the Northeast and my company is rapidly approaching our PDUFA date (fingers crossed) for a new product.

We’ll soon be hiring a new field team that is highly experienced in the industry. Do you have suggestions for the tools to use along each step of the continuous training rollout? I want to make sure I get this right, so that we have a successful launch while being sure our team stays compliant.

Sincerely,

Skittish in Schenectady

Dear Skittish,

I understand your concern! Product launch is a time fraught with compliance risk. Whether this is your company’s first product, or one of many, the risk of not fully preparing a new sales team can keep you up at night. But as opposed to being skittish about this, I dare say you should view a product launch as a terrific opportunity to ramp up the compliance knowledge in the company and build your reputation as a compliance training hero! Here’s how:

Build a Solid Foundation

From a foundational standpoint, I suggest you start with training on interactions with health care professionals to refresh the reps on topics such as the rules around gifts, meals, and consulting arrangements. If you’re doing speaker programs, you’ll also want to cover guidance around those on a comprehensive level. Enforcement around the programs continues to be a focus, with the most recent settlement costing the company $900 million in settlements…yikes! And don’t forget to include your policy on virtual meetings now that they’ve become more commonplace. (By the way, my friends at PharmaCertify have added Managing Speaker Program Risk to their list of customizable off-the-shelf eLearning modules. It’s worth a look, so email them at info@pharmacertify.com to see a demo.)

Launch Screen from the Compliance Foundations Module, Interactions with Healthcare Professionals

Make sure regulations, such as the Anti-Kickback Statute and False Claims Act, are covered in general terms and in context of what they mean for the reps as they interact with HCPs. You could even shape some of the foundational training around the tenets of the PhRMA Code – it’s always a reliable starting point.

You might also think about converting your code of conduct from a static document you hope they read now and then, to a learning tool that reminds them of the core tenets of how they are expected to conduct themselves. And rote repetition of the code in electronic form does not rise to the level of effective training. A well-designed and fresh course will help familiarize the new reps with specifics of your code. (FYI – the PharmaCertify team has lots of fun ideas for how to bring your Code to life!)

One final note on foundational training: the rest of your staff (i.e., your non-commercial employees) need a basic understanding of the health care compliance principles that govern how you do business, so they will need training, too. In this time of increasing enforcement, you need to be able to demonstrate that everyone in your company has received essential compliance training.

Reinforce and Refresh

The possibilities for on-going refresher training don’t stop at the code of conduct though. Consider integrating microlearning modules (PharmaCertify calls them QuickTakes) covering topics pulled from your larger training programs into a curriculum campaign. For example, since gifts and meals present a high level of risk, a five-minute module focused on items of minimal value, cash and cash equivalents, as well as in-office meals, out-of-office meals, and meals at third-party events, is a great way to keep the rules top of mind.

Also, too many people fall into the trap of thinking microlearning just means “short.” My buddies at PharmaCertify take a different view. They define microlearning as any training component designed to reinforce foundational training as part of a continuous learning plan. The formats could include live-action or animated video, workshops, and game-based training, and even strategically delivered quizzes and assessments. The idea is to keep the training nuggets flowing for higher risk areas, which increases retention and enhances learning.

On the live training front, think about games to ramp up learning. If you’ve ever been in front of a group of reps playing any game, you know how they like to compete! As Gordon Gecko said in the movie, Wall Street, “Competition is good.” I know, he really said “Greed is good,” but I got your attention with that one, didn’t I?

This is JEOPARDY! In fact, it’s the only officially licensed JEOPARDY game on the market.

Look for games that have a familiarity to them. A Jeopardy game is great and if you’re interested, I can get you a demo for the only officially licensed compliance Jeopardy game on the market. It’s also easy to customize, so you can add the categories and topics you need to reinforce.

You can take the event to another level by pitting regional teams against each other and adding music, sound effects, and prizes to the mix. If done right, the games will have the participants saying, “that was the best compliance training event I ever attended!” Trust me, I’ve heard it.

There is a trend toward more creative live and virtual compliance workshops, and in my opinion, it is long overdue. Simply having a representative from the compliance department speak to a PowerPoint deck might not cut it in the view of regulatory bodies, and it certainly is not going to accomplish any worthwhile learning objectives.

An image from the virtual Compliance Escape Room Workshop

I even saw a virtual escape room utilized during one recent workshop. In this case, participants solved clues about three scenarios as they competed in teams to “escape” the rooms. It was a big hit at the national sales meeting and won a gold award for Best Advance in Compliance Training from the prestigious Brandon Hall organization.   

Support Their Performance

If there’s one element of the formula for effective compliance training that is most neglected, it’s performance support. Throughout my career in compliance training, I have too often seen training viewed through a myopic lens that is only focused on foundational training and occasional reinforcement. Performance support tools broaden the scope of your training campaign and provide just-in-time guidance.

Support materials can be as varied as interactive PDFs launched on the learning management system, animated video played through the corporate intranet, or an interactive microsite for sharing policy and code information. In addition, tip sheets and reminders about best practices and policies can also be sent directly to reps’ phones or iPads to support them with the information they need in the field.   

Summary

I wish you well with your efforts and good luck with that PDUFA date! Product launch may, at first glance, be nerve-racking from a compliance standpoint, but when you take the time to analyze your current training against your risk, then develop a continuous curriculum to be delivered across your reps’ timelines, you’ll be surprised at how seamless it can be. Just keep that formula for an effective curriculum (foundational + reinforcement + performance support) at the forefront of your planning and I guarantee you’ll sleep much better at night.

Soar high, you hero of compliance training!

Thanks for your question,

Connie the Compliance Training Director     


The Formula for Building a Better Compliance Training Curriculum!

Editor’s Note (September 13, 2022): this post has been updated to include additional suggestions for foundational, reinforcement, and performance support compliance training solutions.

In its guidance related to the evaluation of corporate compliance programs, the Department of Justice repeatedly stresses the importance of appropriately tailored and risk-based training. The guidance suggests prosecutors should “assess the steps companies have taken to ensure policies and procedures have been integrated into the organization.” I can still almost hear the pleas of compliance professionals wondering exactly how they are going to accomplish such integration. The solution is found in a straightforward formula: foundational + reinforcement + performance support = integration (F+R+PS = I). I know, it’s not as simple as the Properties of Equality we all learned in junior high school, but we’ve seen it work time and time again.

Reset the Forgetting Curve

As the Ebbinghaus Forgetting Curve illustrates, the information humans remember after a learning event drops steeply soon after completion of that event. In fact, that loss of recall continues to increase until it finally flattens around 30-days post event. So, F+R+PS = I to the rescue!

Starting with a Strong Foundation

Let’s start with the first elements of the integration formula, foundational training.

Industry-specific foundational training should be used to cover topics such as interactions with health care professionals.

Any successful journey toward integration begins with effective foundational, training. In its guidance, the DOJ instructs prosecutors to consider the form, content, and effectiveness of that training. But what is “effective” foundational training? It begins with relevancy. Does your eLearning feature content to which your learners can relate? Are the scenarios based on interactions and situations your learners are likely to face? Is the content written in plain language? Has the content been vetted by subject matter experts who understand the nuances of interactions with HCPs, HIPAA, or product promotion? For all those reasons and more, broad-based, cross-industry training doesn’t work and is frankly a waste of time and budget. As you know, your sales representatives aren’t benefitting from scenarios featuring ethical discussions between two insurance employees.

Effectiveness also requires a fresh graphic design and user interface. Modern training development tools allow for the use of illustrated images to represent characters such as doctors, sales representatives and MSLs. Let’s be honest, stock photos scream stock photos – or as I call them, “shiny happy doctors and sales reps.” Illustrated characters also offer more opportunity for inclusion of characters that ALL employees can relate to. Your learners want to see representations of themselves in their training.

Finally, effective foundational training is built with proven instructional design strategies in mind. Are the learning objectives specific enough to be meaningful?  Is the content logically organized? Are knowledge checks and interactive exercises appropriately woven into the training? Can the questions in the assessment be mapped directly to the content in the module?

The Compliance Foundations Suite of eLearning modules includes HIPAA for Pharmaceutical Employees .

This isn’t to say effective eLearning always has to be custom developed. Industry-focused, creative, engaging, and modern off-the-shelf training is a great solution for establishing an effective base. So, if you’re with an emerging pharmaceutical or medical device company with limited time and resources, off-the-shelf training is a viable option. Just do your homework and talk to your peers to make sure it’s the right off-the-she solution. (Shameless pitch – we can help!) Of course, custom development does present an opportunity to take your curriculum to another level with more options for branded training laser-focused on your policies if the budget is available.

Also, don’t fall into the current trap of thinking all training has to be short to be effective. Yes, you want to keep foundational eLearning modules no longer than 30 minutes or so, but if 30 minutes are necessary to cover a comprehensive overview of the topic, the learners can sit through it. After all, if we can binge-watch our favorite streaming series, we certainly have the attention span to complete a 30-minute module, assuming it is relevant and engaging.

Reinforcement Drives Retention

Integrate microlearning modules to cover more targeted topics like the 2022 updates to the PhRMA Code.

The second element of the formula for more effective training is reinforcement. When strategically deployed following the initial workshop or eLearning, reinforcement solutions in the form of microlearning modules serve to boost learning, reinforce key topics, and help flatten that nasty Forgetting Curve. For example, if gifts and meals are a high risk for your HCP-facing employees, a scenario-based mini module built around a common situation they face in the field, deployed soon after the foundational training on interactions with HCPs, is an ideal way to increase retention of critical information.

Microlearning modules aren’t the only effective tools for making training more effective, though. Reinforcement learning nuggets could include quizzes and games deployed repeatedly over time. Look for games that can be completed individually or in a multi-player virtual workshop. The Compliance JEOPARDY! game from PharmaCertify, for example, is available in both formats and is easily customized with your content. By the way, it’s the only officially licensed JEOPARDY! game on market and it’s an instantly recognizable way to pull learners into an important reinforcement activity. They’ll even thank you for it.  

The Virtual Compliance Reality Escape Room features a series of customized scenarios and challenges.

Other reinforcement approaches could include virtual or live workshops with content built around the situations sales representatives are likely to face in the field. Why not create a a virtual escape room, for example, with challenges customized for the situations your learners can expect to face in the their daily interactions? (Let me know if you’d like to see a demo of the escape room we built for a client, which recently won a gold Brandon Hall Award for Best Compliance Training!)

The effective integration of compliant practices and policies requires the continuous deployment of a variety of reinforcement solutions. Government agencies like the DOJ and the OIG have made it clear in their guidance, and recent industry settlements and corporate integrity agreements highlight the need as well.

Supporting Their Performance

We’ve come to the ”PS” in the equation that holds the key to achieving integration in a life sciences compliance equation: performance support. Performance support includes those just-in-time resources that people need when they are in-the-moment and can’t remember compliance guidance.

Digital support tools like electronic banners support compliance training messages and themes. When splashed across the company intranet and incorporated into digital messaging from the compliance department and the C-Suite, they remind everyone of the key messages from the foundational and reinforcement training.

Video launched on the company intranet is an effective way to support key messages.

Don’t shy away from the use of video either. Despite what some high-end production companies will tell you, you don’t need to use your entire training budget on a high-end video. You’re not creating Compliance: The Live Action Musical. You’re looking for ways to support your efforts with a creative and engaging video. Tools like Vyond are affordable and easy-to-learn way to accomplish those goals. Many of our clients are developing short (1-3 minute) videos that are pushed out via hyperlink and housed in a library on the compliance page of their intranet. Some even use platforms like Microsoft Stream as an internal YouTube, so that people can rate and comment on the videos.

Finally, materials like quick reference guides support positive behavior and deliver critical reminders when people need them most…as they are about to engage in activities rife with the potential for compliance violation. And other print material like posters and comic books are a great and thematically fun way to drip the learning throughout the duration of a compliance training campaign.

Summary

The key to success and “effectiveness” in compliance training, foundational + reinforcement + performance  support = integration, will not be remembered among the great formulas in history (rest easy Albert Einstein), but any compliance professional would be wise to heed its power. At PharmaCertify, we’ve spent the last 15 years developing compliance training for the life sciences industry. We have the in-house compliance expertise, along with the instructional design and production skill, to help you implement this formula as a necessary step toward meeting the expectations of the regulators, your peers, and perhaps most importantly, your learners.

That’s why we are planning webinars, video-based chats, infographics, more blog posts, and other resources to showcase examples of how our clients are utilizing each stage of the formula to increase the effectiveness of their training. Subscribe to this blog and follow us on LinkedIn and Twitter to keep abreast of the details to follow as we continue to provide the information you need to help reduce risk through training. After all, it’s our mission.

Thanks for reading!  

Sean Murphy
PharmaCertify by NXLevel Solutions

Training Lessons from the Live 2022 Pharmaceutical Compliance Congress (Ignore at Your Own Risk)

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!

Sean Murphy
PharmaCertify by NXLevel Solutions

A New Year, a New and Improved Compliance Training Curriculum

Welcome to 2022 and a brave, new (and hopefully more effective) world in life sciences compliance training! Over the last two years, the industry has had to navigate the convergence of new and important regulatory documents (DOJ’s Evaluation of Corporate Compliance Programs, OIG’s Serious Fraud Alert on Speaker Programs), as well as updates to leading industry guidance (PhRMA Code, AdvaMed Code). Mix in a series of corporate integrity agreements and settlements focused on key topics, along with a global pandemic, and you have a perfect recipe for a shift in how risk is evaluated and remediated.

So, what’s the appropriate method for recalibrating your compliance training curriculum in response to these events and forces? The solution is as easy as A, B, C, and D:  

Assess Your Company’s Compliance Training Curriculum

Regular risk assessment is a long-time best practice for building and maintaining effective compliance programs. It’s nothing new, and as usual, the major conferences from Informa and PCF in 2021 included multiple sessions where risk assessment was a major topic of discussion. But this time, the regulatory guidance and industry code updates added a sense of urgency to the importance of this best practice.

The Compliance Curriculum Analysis Tool

But what good is a risk assessment if you don’t then assess your training curriculum against that risk? When we work with clients, we 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. It is often a revealing process, identifying gaps and redundancies in topics, and when and how the information is covered.

Good news! It doesn’t have to be a complicated process. Using tools like our Compliance Curriculum Analysis Tool (CCAT) can help.  And it can also be as straightforward as evaluating compliance risk for the product you are about to launch and establishing a baseline of online foundational curriculum around topics like HIPAA and Interactions with HCPs. No matter where you are in the product development cycle, know your risk levels as they relate to topics and audiences. Then look for opportunities to effectively address those risks in your curriculum with a continuous stream of foundational and reinforcement training.

Blend the Formats

The 2022 PhRMA Code Changes QuickTake eLearning Module

The days of using one large PowerPoint deck to train on all things compliance during onboarding sessions are long gone. Good riddance. Effective, well-designed training covering critical topics like bribery, kickbacks, HCP interactions, and speaker programs is readily available.

But the curriculum all stakeholders now expect doesn’t stop at eLearning modules covering foundational topics. You should also plan reinforcement training to help ensure that proper behaviors are integrated into your learners’ daily practices.

If your risk assessments show speaker programs to be a big risk area, don’t count on that one eLearning module or live training session to quell that risk. Why not launch a mini module specifically covering the selection and training of speakers? We call them QuickTakes. In fact, today’s development tools allow for smaller, more focused sections to efficiently and cost effectively be pulled from the larger modules.

Virtual workshops and games can be utilized to train on topics best discussed in live environments, where follow-up discussions and dialogue strengthen the core lessons. For example, if your assessments identify off-label promotion as high risk due to the nature of your company’s products, design a “compliance mystery” workshop, with scenarios replicating real-life environments sales representative can expect to experience in the field.

Compliance JEOPARDY!

Or, ramp up the competition and raise the level of learning with an online or virtual game like our Compliance JEOPARDY!, which is currently the only officially-licensed Jeopardy game on the market.

Finally, does your curriculum include performance support and just-in-time tools to help guide the learners before and after training events? Print and digital support materials can be designed in conjunction with the training and delivered to learners where they need it most – at their fingertips in the field.

A blended curriculum is not only the best approach for “making the learning stick,” it’s what the government, the industry, and perhaps most importantly, your audiences, now expect.

Communicate Across the Company

I admit that every time I heard the phrase “tone from the top” over the last ten years, I found myself wondering why the same topic was covered ad nauseum and seemingly at every conference. Then, a variation on that mantra started to seep into the presentations: “tone from the middle.” The reality is that key messages and lessons in compliance are delivered from the middle, more specifically, managers. And bringing those managers into the communication process helps ensure those in the field are reminded of the importance of compliance every day. It’s why presenters at conferences constantly stress the need to “partner with the business” and why compliance needs to be integrated throughout the company.

Speaking of communication, what does your plan look like? If you don’t have one, you should. Digital banners, animated video, and posters help reinforce the themes related to training and carry the messages across the company. For example, a QuickTake module covering kickbacks can easily be exported into a video for hosting on the company’s intranet. Or consider the approach we’ve taken with a number of clients to portray the compliance department in a more approachable light and produce lighthearted videos showcasing the risks involved in engaging with your company’s HCP partners.

Deliver It Continuously

One of my previous blog articles asked what a 170-year-old German psychologist had to do with compliance training and learning. The answer then, and even more so now considering the forces at work in the industry, is “everything.” Hermann Ebbinghaus is credited with theorizing fundamentals of human learning, including the learning curve, the spacing effect, and the forgetting curve. The forgetting curve essentially states that what humans remember after a learning event drops steeply after the completion of that event.

Continuous delivery helps reset the forgetting curve.

What Ebbinghaus theorized is interwoven into the government documents and settlements we’ve witnessed in recent years: “one and done” just doesn’t cut it. Unless you are taking a continuous approach to the delivery of your company’s compliance training components, you’re probably not taking every step possible to maximize the learning.

Are you deploying training nuggets across the learners’ timelines? Does your training plan include ongoing assessments and quizzes to help flatten that forgetting curve and increase knowledge retention? Are you asking for feedback from the learners on the quality of the training materials and adjusting accordingly? Have you explored available platforms for repurposing and sharing your training content?

In the DOJ’s guidance, the agency noted that some “companies have invested in shorter, more targeted training sessions to enable employees to identify and raise issues to appropriate compliance, internal audit, or other risk management functions.” The possibilities for doing that extend well beyond the creation of shorter eLearning modules. The availability of video, animation, podcasts, quizzes, and games, as well the delivery platforms necessary to continuously deliver those components, all create the opportunity to envelop learners in a framework of minimized risk.

Summary

The advent of new regulatory guidance documents and revised industry codes, as well as the implementation of recent industry settlements, affect the way risk is evaluated and judged in the life sciences industry.

We may be facing an onslaught of requirements and regulatory expectations during a time when the norms of business have been disrupted and disorganized, but using the instructional techniques and concepts outlined above, you have the opportunity to not only navigate your way through those changing expectations, but to elevate your compliance training curriculum to one that helps you rest easier on those waves of change.  

Thank you for reading! As always, my colleagues and I at PharmaCertify welcome the chance to discuss the compliance training challenges you may be facing.

Sean Murphy
PharmaCertify by NXLevel Solutions
smurphy@nxlevelsolutions.com

A Preview of the 22nd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress

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.

“Evolving our Operating Model” Discussion Breakouts

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!

Sean Murphy
PharmaCertify by NXLevel Solutions

Five Ideas for Your Compliance Session at the Next National Sales Meeting or POA

Your next national sales meeting or POA is just around the corner! If you haven’t thought of a fun and engaging way to make the content stick during your time in front of the reps, especially with the move to virtual events, all is not lost. There is still time to craft a compelling session to help ensure key compliance concepts are communicated effectively and learning is optimized.

Here are five ideas that might just have your participants saying, “that was the best compliance session I’ve ever attended!” Trust me, it does happen. I’ve seen and heard it myself.

Play Compliance JEOPARDY!

Jeopardy-style games have long been a staple of compliance training and the familiar format continues to be a great way to get your learners’ competitive juices flowing. It’s a popular format that your audience will recognize instantly.

PharmaCertify offers the only officially licensed JEOPARDY! game on the market and wow is it cool! You can populate the game with categories and clues written by our subject matter experts or draw questions from your own policies. Either way, our instructional designers will work with you to create a series of clues that challenge the participants’ knowledge at just the right level to enhance the learning.

Compliance JEOPARDY! is flexible. We offer a baseline off-the-shelf version to get you started, and depending on the amount of time you have at the meeting and your learning objectives, you can include up to 51 clues in one game (including Double JEOPARDY! and Final JEOPARDY!)

Make It a Compliance Mystery

Who doesn’t love a good mystery?  A mystery-themed workshop is an ideal way to present new compliance concepts and reinforce existing knowledge in a live, or virtual, collaborative and information-sharing environment.

When created thoughtfully and using sound instructional principles, a mystery workshop can draw the learners in as they play “compliance detectives” to solve scenarios through their knowledge of compliance best practices and guidance. You can even make it a blended event by rolling out “clues” in the form of email messages, voicemail transcripts, and text messages, before the date of the workshop.

At PharmaCertify, we include a compliance mystery activity in our Compliance Reality Challenge. Participants begin the Compliance Mystery by reviewing the clues they were presented prior to the workshop. Once they complete that review, they are presented with a screen from which they choose red flags. They then answer a series of questions to test their understanding of the scenario and their decision-making skills.

Following the completion of the activity, facilitators briefly have the opportunity to review the scenarios and provide clarification on policies as necessary. After the workshop summary and a review of the key lessons learned, a leaderboard can be revealed to highlight the final scores.

Build a Virtual Compliance Escape Room

Escape rooms are all the rage, and a virtual escape room can be a great device for transferring that popularity into a memorable learning activity.

The escape room can build trust and collaboration as participants work in teams to solve challenges and use codes to escape. An escape room can be a blended event, with core training and other pre-work delivered prior to the activity, which will allow you to focus on specific concepts during your time with the participants.

Escape room activities begin with a scene for the group of learners to explore. Each participant clicks on each “hotspot” to review key information. Once all hotspots have been explored, a “Next” button appears, and participants are presented with a series of questions regarding the scene. As members of a team answer questions, the score for that team is averaged automatically to generate a final team score. The workshops are generally designed for a 45-minute duration, and include introductory remarks, debriefs between activities, and wrap-up remarks.

Build Your Own Compliance Scenarios

Scenario-based learning is a tried-and-true method for helping learners improve their decision-making skills. Scenarios give your reps the chance to apply knowledge from previous training in a safe environment.

Our Compliance Scenarios training game is an easy way to create role-play situations for your next meeting. With Compliance Scenarios, you can transport the audience into simulated interactions with healthcare professionals during the training session.

We’ll work with you to develop discussion points for a series of branching scenarios, and we’ll create the photo or illustrated images to go along with the content. When learners think critically to solve a simple or complex scenario, retention is increased, and learning is enhanced!

Pursue Trivia (see what I did there?)

Who doesn’t like trivia? In fact, did you know that new versions of TRIVIAL PURSUIT are still being released. There’s a new “Master Edition” available with over 3,000 questions? Looks like my holiday shopping list just got a little longer.

Whether they are played online, around the kitchen table, in a bar, or during your company’s training meeting, trivia games are a powerful way to pull participants into a fun learning experience.

Compliance Trivia by PharmaCertify is customizable and can turn your session into a competitive experience through an assortment of question types, including multiple choice, select all that apply, image match, and polling.

Even if you’ve already mapped out an activity for that next meeting, but you need one more reinforcement activity to fill the time available, Compliance Trivia will leave your audience brimming with confidence and compliance knowledge.

Summary

The time available to capture the audience’s attention at a sales meeting may seem fleeting but the lessons your participants learn will be incorporated in their daily work activities well beyond the session. Themed workshops and games are just a few of the options available to “make the learning stick,” but an engaging and meaningful session is a necessary and important step in the continuous process of reducing risk and creating a stronger culture of compliance and ethics in your company.

Thanks for reading. As always, I welcome any comments or feedback.

Sean Murphy
PharmaCertify by NXLevel Solutions

Key Training Takeaways from the 2021 Virtual Compliance Congress for Specialty Products

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.

Thanks for reading!

Sean Murphy
PharmaCertify by NXLevel Solutions

Key Training Takeaways from the KENX Biopharma and Biotech Corporate Compliance Summit

There is a new player in the life sciences commercial compliance conference space. After focusing on the GxP compliance field for years, the Knowledge Exchange Network (KENX) has joined the lineup of organizations targeting the commercial side of the industry. With Informa Connect (CBI) and PCF setting such a high bar for compliance conferences for years, I was looking forward to the possibility of hearing even more ideas for building an effective compliance program during KENX’s recent Biopharma and Biotech Corporate Compliance Summit webinar.

And that is exactly what happened, as an impressive array of industry leaders and established vendors presented new tips and suggestions for reducing risk and building an effective compliance program for established and emerging companies alike. Here are five key takeaways from the day-long webinar that may help you optimize your compliance training curriculum (that is, after all, our mission and passion at PharmaCertify):

1. “Establish a relationship with senior sales personnel so compliance is top of mind for new hires from the start.”

While the “partner with the business” refrain has been espoused frequently over recent years, the idea of turning to the sales leaders to make sure sales representatives hit the proverbial ground running is a compelling twist – particularly for compliance professionals from emerging companies, where resources are limited. Just as compliance needs to have a seat in the business, the business (and sales) needs to be part of the compliance committee to help establish a baseline of compliance expectations and avoid miscues from the start.

2. “The best practices and the rules are evolving quickly, especially during the pandemic. Keep in touch with your peers to discuss how they are managing the evolution to virtual interactions and changing policies.”

I have written about how the larger compliance conferences offer a rare opportunity for compliance professionals to interact with their peers one-on-one and soak in best practices for compliance. But isn’t it a shame that those opportunities are so rare? They don’t have to be. Organizations like KENX, Informa Connect, and PCF offer smaller one-day sessions focused on a plethora of topics, and even when conducted virtually, these programs offer a chance to connect with those who are dealing with the same challenges as you. Even if it’s through a compliance training group like the one we created on LinkedIn, sharing common experiences, successes, and bumps in the road is a critical tool for navigating the morass of changing policy and priorities during the pandemic.

3. “Study the 2020 OIG Fraud Alert to identify the areas that are top of mind for government regulators moving forward.”

A cursory review of the special fraud alert released by the OIG last November reveals nothing revelatory or surprising in terms of the fraud and abuse risks related to speaker programs. Rather, as was noted during the webinar, the importance of the alert lies more in the mere fact that the agency released it. On page 3 of the document, the agency states “Our investigations have revealed that, often, HCPs receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend.” Anyone who has been paying attention to recent settlements is not shocked by such a statement but the language points to two of the areas the OIG considers to be of primary concern for compliance violations. Consider this special alert as a shot across the bow of the industry. The focus on the speaker programs isn’t going away anytime soon, and now is the time to make sure your policy and training targeting reps, presenters, and vendors is up to date and covers all the risk areas.   

4. “Trade show vendors have probably not thought through the potential compliance concerns of holding the meetings virtually. You need to be engaged with them about those details beforehand.”

Compliance training cannot end with employees, especially during a pandemic when the rules are constantly changing. When a vendor is organizing a trade show or conducting any business on behalf of the company, the risk grows exponentially. Are your trade show vendors aware of the rules and your policies regarding product promotion and scientific exchange? Have you fully considered the ramifications of building and delivering online training for vendors? Don’t assume that your vendors are going to take the same diligent approach to compliance as you do and don’t just hope they stay abreast of the latest best practices around virtual communication. If you launched vendor training prior to the pandemic, consider adding microlearning refresher training to highlight changes in policy.

5. “Utilize a campaign approach to training to support branding efforts and make the concepts more memorable.”

The session titled, “Training – Best Practices for Promotional Compliance challenges in a Virtual World, Creative Solutions to Keep Sales Reps from Going Off the Guardrails” offered a range of tips for changing behavior through core training, performance support, and reinforcement training (I know, I’m biased because the co-presenter was my colleague, Dan O’Connor, but you really should see this slide deck). No matter your budget, rolling out branded components across a learner’s timeline, rather than launching one large bolus of content, has been proven to enhance learning and increase the retention of that content. The “Forgetting Curve” is real, and if you want to make your training more memorable, you need to make it continuous.

All the presentations during the Biopharma and Biotech Corporate Compliance Summit offered enough nuanced twists on familiar topics to make a one-day commitment of time worthwhile. The last year has seen an upheaval in how the industry conducts business, which has resulted in a sudden need for changes to compliance practices and policies. Even with established organizations like PCF and Informa Connect continuing to keep their own events timely and relevant, there is always room for another player. Welcome to the party, KNEX.

Thanks for reading!

Sean Murphy
PharmaCertify

Ten Training Takeaways from the 21st Pharmaceutical and Medical Device Ethics and Compliance 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.

  1. 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.
  2. 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!
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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?
  9. 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.
  10. 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.
  11. Thanks for reading!

    Sean Murphy
    PharmaCertify By NXLevel Solutions

Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

Part 3: Compliance Training in An Uncertain Time

This is the third and final post in a series covering the compliance training lessons learned at the 2020 Virtual Pharmaceutical Compliance Congress. Throughout the conference, regulators and industry professionals stressed the need for constant evaluation and modification of all aspects of a compliance program, including the training program. The successful mitigation of risk in a program requires continual careful documentation and evaluation of training topics, audiences, and deployment frequency, as well as the effectiveness of the tools utilized to deploy the training.   

We’ll see you back in Washington D.C. for PCC2021!

To say 2020 has been an eventful and tumultuous year for the life sciences industry is an understatement. The COVID-19 pandemic has forced sudden change in the way in which business is conducted and created a milieu of unforeseen compliance concerns. Those issues were certainly not lost on the presenters at the 2020 Virtual Pharmaceutical Compliance Congress as timely suggestions for managing the “new normal” were blended with more traditional content related to building and managing an effective compliance program. One presenter summarized it interestingly when she said, “the plan you prepared in January does not make sense with what you need to focus on now.”

The need for on-going risk assessment was repeated throughout the conference, beginning in the Enforcement Docket Deep Dive session with one U.S. Attorney commenting, “programs must be updated over time to align with changes in the business and changes in settlements.” That risk assessment includes the on-going analysis and evaluation of a training curriculum, particularly as the way in which the industry interacts with each other and with HCPs continues to evolve.

A Rush to Roll Out New Training

The rush to cover new topics based on updated policies for virtual interactions can lead to a convoluted curriculum and do more harm than good. Regularly scheduled, comprehensive curriculum analysis helps ensure ongoing training covers existing and new topics with the right audiences, at the right level of detail, with the proper frequency based on the level of risk – and that analysis should not be pushed aside solely for the sake of expediency.

A “risk level” analysis has always been a foundational step in identifying content gaps and the need for updates in the topics covered. 2020 is no exception as the pandemic has forced a change in the way field teams interact with HCPs and conduct support programs. During the session, Look at How In-House Legal and Compliance Departments are Evolving in 2020 to Help Address Business Challenges, one compliance officer succinctly put it, “The way in which we do business has changed, so policies need to be more precise and training must be more engaging.”

Curriculum analysis begins with documenting a detailed list of topics covered in current training materials versus those required by the shift to virtual engagements. (Incidentally, PhRMA’s Statement on Application of PhRMA Code Section 2 During Emergency Periods is a good starting point for those changes). Your documentation should specifically include the target audience for each topic and indicate the level of risk each topic represents for each audience, as well as the frequency and level of detail at which each topic is presented.

Following the documentation phase, an analysis is necessary to determine whether the level of training versus the risk for the audience is sufficient. As a final step, solutions to address gaps and redundancies can be planned as new topics are added to the curriculum.

Increasing Retention and Enhancing Learning

An effective training curriculum also requires ongoing “engagement evaluation” to ensure learning is maximized. Let’s face it, the sudden onslaught of new and updated policies on virtual interactions is causing confusion. During the Candid Conversations on Key Themes and Industry Insights session of the conference, more than one panelist cited the movement to virtual programs as the topic keeping them up at night. The variables abound, and just updating foundational training programs with new policies is risky and flawed. More novel methods of training (quizzes, gamification, microlearning, etc.) offer opportunities to integrate nuggets of information into the curriculum and cut through the clutter of change to help raise engagement levels.

One industry speaker highlighted this best when he said, “You need to give them the tools to deal with awkward situations in this new way of conducting business, like how to respond to off-label questions.” That tool list begins with updated training components deployed repeatedly and strategically across the learner’s timeline. The changes wrought by COVID-19 only heighten the need to evaluate your curriculum for its power to change individual behavior – especially with updates to policies and changes in SOPs happening at such an unforeseen rate.

Unsolicited Change

The unknown can be daunting. The writer and poet Raheel Farooq once wrote, “The greatest fear in life is not of death, but unsolicited change.” We, as an industry, a country, and a world, have certainly seen our share of unsolicited change this year and it wasn’t lost on the presenters at this year’s conference. Panelists were quick to admit they didn’t have all the answers in terms of how training, and compliance in general, should be managed in these tumultuous times, but that’s okay. I’m confident most attendees would agree that the opportunity to share concerns, questions, and ideas was worthwhile, valuable, and reassuring. Kudos to all the presenters and conference organizers for making the 2020 Pharmaceutical Compliance Congress such a success under such difficult circumstances. I look forward to attending the 2021 conference “live and in-person,” as I am sure do you.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions