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

Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

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

A Preview of the 2020 Virtual Pharmaceutical Compliance Congress

As you may have expected, CBI’s Pharmaceutical Compliance Congress is going virtual in 2020. Whether presented live or online, the conference remains one of the few opportunities for those in life science compliance to interact with their peers and learn tips, suggestions, and best practices from industry leaders and government representatives. Live panels and on-demand presentations spread across the agenda represent a wide variety of the topics important to anyone striving to build and maintain a strong and effective compliance program and ethical culture. Here are a few of the presentations I am particularly looking forward to.

On-Demand Presentations

To provide an extensive range of content, organizers have made some sessions available on demand. Or, as they say it on the website, “on-demand content is available anytime, to accommodate your needs and schedule.”

On-demand titles range from Strategies for Field Team Compliance, to Best Practices Around the World for Global Compliance Management, and Hub and Specialty Pharmacy Contract Oversight and Risk Assessment, to name just a few. Make sure you watch the State-of-the-Art Compliance Training panel discussion being hosted by my colleague from PharmaCertify, Dan O’Connor. Dan will be joined by Alex Ganz of Akebia Therapeutics, Jeffrey Hagy of Regeneron, and Erica Powers of Sage Therapeutics for a deep dive into practical and innovative training approaches that you can apply immediately. I’ve seen the notes on this one, trust me, you don’t want to miss it. The full list of on-demand sessions is on the conference website homepage: https://informaconnect.com/pcc/.

Day 1: Monday August 10

After opening remarks and the video review of the year in compliance, James Stansel, Executive Vice President and General Counsel of PhRMA, will present the organization’s annual address, Healthcare Policy Update – Current State of Regulatory Reform Driving Innovation and Access. Then Gary Cantrell, Deputy Inspector General for Investigations at OIG, will deliver the annual OIG/HHS Update.

The panel presentation from the U.S. Attorneys’ offices typically offers a revealing look into the trends and topics currently in focus for the government. This year, Enforcement Docket Deep Dive – Analysis of Recent CIAs and Settlement Trends features representatives from offices around the country, including New Jersey, Southern New York, Nevada, and Massachusetts. Expect patient assistance programs to be at or near the top of the list this year – and, on this note, PharmaCertify will soon offer a new eLearning module covering patient programs. Send me a note if you’d like to preview the content outline.

From 3:00 pm to 3:45 pm, participants choose between two live Q&A sessions, Boot Camp Q&A, with Perri Pomper from Clinical Genomics, Ed Sleeper from Esperion, and Daniel Kracov and Mahnu Davar, both of Arnold & Porter; and Primer Q&A with Rahul Khara of Acceleron Pharma, and Seth Lundy from King & Spalding.

The Opening Night Networking Happy Hour follows the Q&A sessions, and when I preview the live conferences, this is where I typically suggest attendees not miss this great opportunity to interact with peers in one-to-one conversations. There is no reason to believe the virtual networking won’t be as valuable, as attendees and presenters clearly look forward to these rare chances to exchange experiences “face-to-face.” My colleagues and I will be there!

Day 2: Tuesday August 11

The opening session on Day 2 is compelling for its title, When Drug Research is Personal: Fireside Chat with Amicus Therapeutics’ CEO and CRO on the Criticality of Compliance in Advancing Lifesaving Therapies. For those of us who work in compliance training, making that training more meaningful to the individual learner is one of our persistent goals. If our clients can communicate the importance of the training to the careers of the learners, and the lives of the patients, learning is enhanced. I am looking forward to hearing John Crowley and Patrik Florencio describe how the “criticality of compliance in advancing lifesaving therapies” is put into practice at Amicus Therapeutics.

Scanning the agenda for the rest of Day 2, anytime the words “digital revolution” appear in a session title, I am intrigued. So, I will be curious to hear Chad Morin of bluebird bio. and Brian Berry of Vertex Pharmaceuticals describe that revolution in the Patient Centricity and Compliance in the Digital Revolution session.

From 3:00 pm to 3:45 pm, attendees choose from one of four hot topic roundtables. The roundtables are diverse and compelling, depending on your objectives. As always, I recommend dividing with colleagues, or even sharing notes with a new friend you meet in the networking session, to conquer and gather as much information as possible.

Two of the roundtables jump off the screen for me. The word “checklist” in any title always catches my eye. Calling All Emerging Biotechs – Pre-commercial Compliance Considerations and Checklist with Tiago Garrido of Verastem Oncology, Rupa Cornell of Takeda, and Trish Dring of MacroGenics looks to be an interesting primer for anyone in the unique position of preparing a product launch. And, since our training is so often targeted to field teams and the risks they encounter in interactions with HCPs, the Strategies for Field Team Compliance, with Erica Powers of Sage Therapeutics, Patrick Mooty of Sumitomo Dainippon Pharma America, and Julianne Brierley of Novartis will be on my list.

Day 3, Wednesday August 12

Wednesday’s agenda begins with the CCO Showcase: Cutting-Edge and Proactive Models Driving Compliance and Transcending Silos Across the Business. Kudos to conference organizers for scheduling such an impressive lineup of chief compliance officers: Daryl Kreml from Sage Therapeutics, Beth Levine from Regeneron, Jill Macaluso from Novo Nordisk, Bryant Aaron from Novartis, Tina Beamon from Karyopharm Therapeutics, and Joshua Marks from Boehringer Ingelheim. Dedicating time for follow up Q&A after the presentation is a great idea since the interaction with the audience usually offers some of the most interesting exchanges of ideas.

Following the DOJ and SEC Insights session from 2:00 pm – 2:45 pm (e.g., the U.S Attorneys session is always worthwhile) attendees are encouraged to participate in “peer-to-peer networking time.” Each attendee will have his or her own virtual meeting room for what is described as a “streamlined networking opportunity.” It’s another attempt by organizers to provide for personal interaction, and regardless of the outcome, they should be applauded for the effort. Think speed dating without the detail about long walks on the beach and pina coladas.

Day 3 closes with additional roundtable discussions intended to foster small group discussions. Rather than dedicate Wednesday’s roundtables to specific topics, I have been informed the focus will be on “thoughts from the day and conference so far.” I like it!

Day 4, Thursday August 13

Thursday’s agenda kicks off with what should be a worthwhile discussion about navigating the sea of life sciences compliance challenges in the crazy year that is 2020 with a session titled, A Look at How In-House Legal and Compliance Departments are Evolving in 2020 to Help Address Business Challenges. John Oroho from Porzio will moderate the panel joined by Tara D’Orsi of Kyowa Kirin, Michael Clarke of ConvaTec, and Michael Hercz of Sentynl Therapeutics.

Following a late morning session focused on emerging risk areas from industry advisors (hey, how come I wasn’t invited?!) and a lunch break, the day continues with a Small Group Interaction Hosted by Track Presenters, then into the series of live hot topic roundtables from 3:45 pm to 4:30 pm.

Two roundtables stand out for me based on the hot topics in compliance training: Speaker Programs – Current Enforcement Trends, Best Practice Benchmarks and Future Fate with Peter Agnoletto from Sanofi, John Knighton from TherapeuticsMD, Jennifer DeVincenzo of Sobi, and Charlene Davis of Aerie Pharmaceuticals; and Zero-In on Compliant Patient Interactions, with Terra Buckley of Mesoblast, Rahul Khara of Acceleron Pharma, Laurie Durousseau of Rigel Pharmaceuticla, and Christie Camelio from TG Therapeutics.

Day 4, Thursday August 13

The conference closes with two sessions sure to draw a large audience of attendees. First up is, Anti-Kickback Accusations and the Aftermath — An Inside Look at Sales and Marketing Practices Under Fire with Jonathan Roper, a former district sales manager for Insys Therapeutics. The Insys case obviously holds a deep cauldron of lessons learned in every aspect of compliance, and its impact continues to reverberate across the industry.

Finally, conference organizers could not have picked a better session to close with than Empowerment, Diversity and Inclusion. Sujata Dayal of Medline Industries, Jim Massey, formerly of AstraZeneca, Maggie Feltz of Purdue Pharma, and Veleka Peeples-Dyer from Baker & McKenzie LLP will delve into what is certainly a timely and important topic in today’s world.

See You at the Conference

The logistics involved in the transition to a virtual conference must be daunting. CBI, Informa Connect, and all the speakers, are to be congratulated on their efforts and dedication to bringing so much critical content to the agenda. It looks to be a fantastic five days of learning and I hope this information provides you with more context on some key topics that caught my interest.

If you’re attending the conference, I hope to see you in the virtual PharmaCertify booth, where you can learn more about our training products and services and share thoughts about the conference. If you have not yet registered, we still have $500 sponsor discount registration certificates available. Contact us at info@pharmacertify.com to take advantage of this opportunity to join us.

Thanks for reading. I will see you online at the conference!

Sean Murphy
Product & Marketing Manager
PharmaCertify by NXLevel Solutions

Dear Connie, the Compliance Training Specialist, Tackles Return-To-Work Policy Training

Welcome to “Dear Connie, the Compliance Training Specialist,” where we answer questions about compliance training topics and present solutions for strengthening your compliance culture and reducing risk.

This week: Don’t forsake the fundamentals when building return-to-work policy training.

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Dear Connie,

As my company considers reopening our offices under the threat of COVID-19, I’ve been asked to create training based on our new back to work policy. The policy covers precautionary measures (wearing a mask, hygiene, social distancing, etc.) as well as the potential risk factors (international travel, living with someone who has tested positive, sore throat, shortness of breath, etc.).

What type of training do you recommend based on this unique content? Obviously, face-to-face training is not plausible right now, but is one eLearning module enough for a topic this important?

Signed,

Cautious in California

Dear Cautious,

Great question! As the life sciences industry, and the country in general, plans a careful return to work, now is the time to finalize a training and communication plan to help maximize the safety and well-being of employees. A topic this important deserves not to be rushed and framing the challenge within the context of the ADDIE model is important.

Analysis

You don’t want to miss any instructional challenges on a topic like this one. For example, what are the different roles of the learners? Do you have to consider different training tools for office staff versus lab employees? How about field employees? What pre-existing knowledge does each group bring to the training? Only after you’ve established the learner groups and identified the challenges of reaching each of those groups, can you start to design the proper training.

Design

Now you need to establish the learning objectives and think about how the content will be structured and what tools will be utilized. I would certainly consider a campaign approach, perhaps starting with an eLearning module, followed by other learning nuggets, to make it more memorable and engaging. You may want to also consider on-site posters to reinforce key messages, like the need for employees to follow the rules on washing hands and not touching their faces.

Development

In a case like this, development extends well beyond just creating a storyboard for an introductory eLearning module. The content needs to be organized in a manner that maximizes the engagement for each group, as determined in the design phase. The tools and media utilized to emphasize key messages are important. Animated video, for example, is a popular trend, but you need to be careful the animation doesn’t present such serious content in an inappropriate or humorous manner.

Implementation

Don’t fall into the trap of thinking that since this is critical to their safety and well-being, the learners are going to welcome the training with open arms and dive in enthusiastically. Implementing the training in a manner that optimizes retention is critical, perhaps more than ever. Consider the way in which lessons are “chunked” and delivered across each learner’s timeline.

Evaluation

Training intended to help employees learn the rules of returning to work during the COVID-19 crisis should be evaluated and adjusted accordingly. Gather feedback from the learners through surveys and personal outreach. You need to know it’s working, and you need to answer the learners’ questions. Consider sending out short updates as the Centers for Disease Control (CDC) issues new guidance. Don’t let the training get stale!

Summary

The COVID-19 pandemic has changed the life sciences industry, but the fundamentals of memorable and effective training stay the same. Now is not the time to abandon those principles and practices to expedite the development and launch of new policy training. In fact, when faced with the challenges of ensuring the health and safety of employees, just the opposite is true.

My friends at NXLevel Solutions have over 15 years of experience developing policy training that improves retention of content and changes learner behavior. Contact Dan O’Connor at doconnor@nxlevelsolutions.com to ask how they can help ensure your “Return to Work” training helps maximize the safety of your company’s employees during these uncertain and crazy times.

Thanks for the question and stay safe!

Connie

In a Virtual Detailing World, the Rules Regarding Good Product Promotion Still Apply

Life sciences detailing has changed, even if only temporarily, but the rules and best practices related to good product promotion have not. As field sales teams acclimate themselves to the reality of meeting with healthcare professionals through virtual means, they need to ensure those rules aren’t lost in the milieu of that change.

For example, no matter the means by which promotional speech is delivered, the FDA defines it as “any affirmative statement about a prescription drug or medical device.” Regardless of format, promotional statements made while meeting with healthcare professionals must always be truthful and accurate.

Representatives must never exaggerate or mislead the healthcare professional regarding the use, safety profile, or any other aspects of the product and any statements made about a product must include the benefits and the risks associated with the use of the product. They must never overstate the effectiveness of the product, make efficacy claims not supported by substantial research or misrepresent clinical study data. Fair balance cannot be ignored just because a rep is not meeting with the healthcare professional in person.

Products may only be promoted for uses approved by the FDA. In fact, if a healthcare professional asks a representative about an unapproved or off-label use, the rep needs to refer the question to the medical affairs department and, even during a virtual visit, a rep must never steer a conversation with the intent of prompting the healthcare professional to ask an off-label question.

Now is not the time to let the emphasis on good and compliant product promotion slip through the cracks. Updated training and microlearning covering topics like promotional speech, the Bad Ad Program, the use of social media, off-label marketing, and the dissemination of reprints and scientific publications is more important than ever to keep field sales teams compliant and effective.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

Note: the training content shared in this post is from our Good Product Promotion eLearning module, one of the 26 customizable modules available in our Compliance Foundations suite.

 

My First Glance at the Agenda for the 17th Annual Pharmaceutical Compliance Congress

The 17th Annual Pharmaceutical Compliance Congress is scheduled for April 29 – May 1, 2020 in Washington D.C.

When scanning an agenda for an upcoming compliance conference, I begin by identifying the presentations that feature new topics, or ones that offer a compelling twist on a long-standing topic. This isn’t to suggest you should ever focus exclusively on the “new and shiny” sessions over those that have a more familiar ring. For those of us steeped in many years of conference attendance, sessions like DOJ and SEC Insights and Third-Party Risk Assessment and Oversight are always worthwhile for the updates offered by industry leaders and government regulators.

My initial review of the agenda for CBI’s 17th Annual Pharmaceutical Compliance Congress, scheduled for April 29 – May 1 in Washington D.C., reveals an intriguing mix of new and bold content, along with tried, true, and recognizable presentations. The conference is consistently one of the “can’t-miss” opportunities for life sciences compliance professionals to interact with their peers and hear best practices and suggestions for reducing risk across their companies. From a training development perspective, the presentations help keep us aware of important content trends, as we strive to provide training products you need to continually evolve your curriculum and address compliance risk.

With that in my mind, here are my thoughts on some of the sessions planned for this year’s conference.

Day One – Wednesday, April 29, 2020

CBI has scheduled three concurrent “summits” to open the conference. Summit 1, Bio/Pharma Compliance Boot Camp appears to be an ideal opportunity for those attendees new to compliance to gain a foothold on the topics that form the foundation of the industry. Perri Pomper of Clinical Genomics and Ed Sleeper of Esperion will be joined by Mahnu Davar and Daniel Kracov of Arnold & Porter to cover the essentials. If you are new to the industry, you don’t want to miss this one.

After a networking and refreshment break in the Exhibit Hall (shameless plug – don’t forget to stop by the PharmaCertify booth), three more concurrent summits are planned for the afternoon. Summit IV, Primer Course on Compliant Patient Interactions, from Clinical to Commercial, offers an update on an obviously hot topic, from Rahul Khara of Acceleron Pharma and Seth Lundy of King & Spalding. In Summit V, Compliance and Legal Watch-Outs for Partnering and Deal-Making, Erik Eglite of Aurina Pharmaceuticals will address the compliance challenges inherent in product partnerships. Summit VI, Empowerment, Diversity and Inclusion, stands out as something new and compelling for this conference. Kudos to CBI, as well as presenters, Sujata Dayal of Johnson & Johnson, Jim Massey of AstraZeneca, and Maggie Feltz, of Purdue Pharma, for taking on such an important and timely topic.

Day One closes with the PCC Kick-Off Party and Welcome Cocktail Reception. This is one of the best opportunities you’ll have to interact with your peers while visiting the vendors who provide an array of the services you need to build a stronger culture of compliance. While there, visit the PharmaCertify booth to see demos of our newest compliance training products, all designed to help you enhance the retention of key policies and regulations in the field and across the company.

Day Two – Thursday, April 30, 2020

Following a networking breakfast, and the chairperson’s opening remarks, Day Two begins with a Regulatory and Enforcement Showcase, featuring presentations from representatives of PhRMA and  government entities, including the OIG, various U.S. Attorney offices, the DOJ, and the SEC. The Enforcement Docket Deep-Dive is the annual review of recent corporate integrity agreements and settlements. The panel features an impressive array of representatives from U.S. attorney offices around the country. Consistently, from year to year, these enforcement updates offer critical insight into the latest government oversight trends.

The session titled, Chasing Miracles – When Drug Research is Personal jumped off the screen for me. As a company dedicated to the development of compliance training that reduces risk on a sustained basis, we strive to make that training relevant, personal, and meaningful. I look forward to hearing John Crowley and Patrik Florencio, both of Amicus Therapeutics, discuss how they introduce and communicate the “criticality of compliance in advancing lifesaving therapies,” as it is described in the agenda.

Following the networking lunch, attendees choose from six concurrent workshops. While that may seem like a daunting decision, I recommend partnering with colleagues and associates to divide and conquer. Sharing notes over dinner or coffee is a powerful way to get the most out of the conference and bring more actionable knowledge back to your job.

While all the workshops look to be worthwhile on the surface, three stood out for applicability and relevancy to risk areas. First, Calling All Emerging Biotechs – Pre-Commercial Considerations and Checklist appears to be an ideal opportunity for anyone working with a smaller company, with one product commercialized or soon to be commercialized. I am anxious to hear if Eric Baim of Dovetail Consulting, Tiago Garrido of Verastem, and Rupa Cornell of Stealth BioTherapeutics touch on training as they cover the unique risk and resourcing challenges faced by companies in this tier.

On the hot topic front, the Enforcement Snapshot and Best Practices Related to PAPs, Coupons, Copays and Foundations addresses the risk that seems to be on everyone’s mind, including the collective ones at the OIG. Stephanie Doebler of Covington and Burling LLP, and Katherine Chaurette from Blueprint Medicines Corporation will present.

On the persistently relevant front, Third-Party Risk Assessment and Oversight, with Dennis Barnes of Mayne Pharma, Tali Guy, of Teva Pharmaceuticals, and Michael Clarke of ConvaTec, will surely be relevant for anyone whose company conducts business globally through third-party vendors. That’s a wide swath.

The concurrent workshops continue throughout the afternoon, with six from 2:55 pm to 3:55 pm and six more from 4:25 pm to 5:30 pm. Workshop G has a compelling title in line with the earlier one focused on emerging biotechs, “Product Approved, Now What? Building Out the Compliance Infrastructure with Limited Resources.”  It’s a topic near and dear to the hearts and budgets of many of our clients and I will be listening closely for how Jeffrey Levitt of Stemline Therapeutics, John Knighton, of TherapeuticsMD, and Jim Flaherty of Rhythm Therapeutics handle development and deployment of training on those limited resources.

Back on the hot topic front, Workshop K, Hub and Specialty Pharmacy Oversight and Risk Assessment, features Sarah Whipple of Akebia Therapeutics, and Meenakshi Datta of Sidley Austin; and I am interested in hearing their expert analysis on assessing the risks associated with hubs, and of course, how that risk is addressed in training.

Finally, you do not want to miss Workshop P, State-of-the-Art Compliance Training, with Erica Powers of SAGE Therapeutics, and my colleague from PharmaCertify, Dan O’Connor. In this case, “state-of-the-art training” may not mean what you assume it means in terms of design and budget. Erica and Dan will present different methods for addressing risk and deploying more effective training, no matter your learning objectives and business goals.

Day Three – Friday, May 1, 2020

If the multitudes of workshop choices on Day Two aren’t enough to satiate your hunger for compelling compliance content, CBI has scheduled five full sessions followed by your choice of five tailored content tracks, with two presentations per track:

  • Track 1: Speaker Programs – Current Enforcement Trends, Best Practices Benchmarks, and Future Fate
  • Track 2: Commercial and Government Pricing Transparency and Reporting
  • Track 3: Taking Monitoring, Auditing, and Investigations to the Next Level
  • Track 4: Zero-in on Compliant Patient Interactions
  • Track 5: Clinical Trial Legal and Contracting Considerations and Risk Management Strategies

Among the presentations that precede the track sessions, Lessons Learned from the Field. Anti-Kickback Accusations and the Aftermath – An Inside Look at Sales and Marketing Practices Under Fire should be interesting to say the least. If the title alone wasn’t intriguing enough, the presenter is Jonathan Roper, former district sales manager for Insys Therapeutics. Roper was charged with violating the Anti-Kickback Statute in connection with his participation in the company’s scheme to encourage HCPs to prescribe its fentanyl-based sublingual spray. I am encouraged to see that along with sharing his story from the Insys trenches, Roper is expected to cover the importance of an effective compliance training program in his comments. Buckle your seat belts, it’s going to be an interesting 30-minute session.

An Opportunity to Attend

The sessions I cover above represent only a fraction of the veritable plethora of important content covered in the three-day conference. Whether you work as an n of 1, or by contrast, you have access to a wealth of resources and personnel, the conference offers countless opportunities to bring back the information you need to build, maintain, and grow a better program and culture of compliance.

As a conference sponsor, we are offering a significant discount on the registration fee. Contact me at smurphy@nxlevelsolutions.com if you are interested in this opportunity, and we will see you in Washington!

Be a compliance training hero, with a little help from PharmaCertify…and a discount on the conference registration!

Sean Murphy
Marketing Manager
PharmaCertify by NXLevel Solutions

The 2019 DOJ Guidance Document: A Baseline for Life Sciences Compliance Training

Sean Murphy
Product and Marketing Manager

One of the significant events of 2019 affecting life sciences compliance was the April release of a new guidance document, Evaluation of Corporate Compliance Programs, (https://www.justice.gov/criminal-fraud/page/file/937501/download) by the criminal division of the Department of Justice (DOJ).  The primary intent of the document is to guide prosecutors and courts as they evaluate corporate compliance programs, but it also serves as an important baseline for life sciences businesses evaluating all areas of their compliance programs, including the training curricula.

The guidance document highlights three questions for prosecutors to consider when evaluating a program:

  1. Is the corporation’s compliance program well designed?
  2. Is the program being applied in good faith?
  3. Does the corporation’s compliance program work in practice?

In this post, I examine the DOJ’s document in more detail, and discuss its implications for your compliance training curriculum.

Risk-Based Training

In reference to a “well-designed compliance program,” the DOJ stresses the need for prosecutors to focus on whether a company’s program is customized for the particular risk profile of that company. According to the guidance, prosecutors should “understand the company’s business from a commercial perspective, how the company has identified, assessed, and defined its risk profile, and the degree to which the program devotes appropriate scrutiny and resources to the spectrum of risk.” The company’s periodic training and certification should include all “directors, officers, relevant employees, and, where appropriate, agents and business partners.” In addition, training should be tailored to “audience size, sophistication, or subject matter expertise.”

In pursuit of these standards, foundational training is an effective method for providing a baseline, but additional risk-focused content continuously delivered to individual business units is one way to address that risk. As an example, scenario-based mini modules covering the topics highlighted in risk assessments and audits of the compliance hotline should follow the more comprehensive foundational training for each business unit to make it more relevant and engaging. In addition, microlearning nuggets in the form of quizzes, assessments, and contests have been proven to drive higher retention rates when delivered strategically across a learner’s calendar. Targeted, continuous learning covering the topics deemed critical to each business unit is the key to truly reducing risk.

Curriculum Analysis

On the topic of risk-based training, the DOJ recommends prosecutors ask, “What analysis has the company undertaken to determine who should be trained and on what subjects?” In line with that suggestion, a compliance curriculum analysis is a critical first step for any compliance professional interested in understanding the details of existing organizational training and it’s a necessary starting point for the reconfiguration of that curriculum to effectively address the risks. The categories covered in the analysis should include:

  • Training Type (eLearning, Live, Webinar)
  • Topic(s) Covered
  • Level of Training (Awareness, Detailed, General, etc.)
  • Length
  • Audience(s)
  • Risk Rating Per Audience (Low, Medium, High)

An instructional design analysis should also be included to determine if the proper learning objectives are established and followed, and the visuals, audio, navigation, and assessment are optimized for learning. The data should then be curated into a spreadsheet with sortable cells and columns to allow for an organized and multi-level review of all training programs and topics. At PharmaCertify, we use our Compliance Curriculum Analysis Tool, or CCAT, to assist our clients with this analysis. Once the CCAT is complete, we summarize to highlight the strengths, gaps, and redundancies in the overall curriculum.

Test and Test Again

The document also delves into the measurement of training effectiveness by encouraging prosecutors to ask if employees have been tested on what they learned and how the company has addressed employees who fail all or a portion of the testing. While the inclusion of standard assessments with each course is an assumed necessity, using assessments as learning tools has been shown to strengthen long-term memory.

A study by Jeffrey D. Karpicke and Henry Roediger III, of the Department of Psychology at Washington University revealed that learners are poor judges of what they remember, and when given the choice, they stop studying before they have mastered the subject. So even when they think they know it, they don’t, and assessments spaced repeatedly over time is the best method to increase the retention of critical compliance policies and best practices. When possible, alternative types of tests should also be deployed, including:

  • Pre- and post-training tests to measure gains scores
  • Priming assessments to encourage the formation of cognitive schema
  • Diagnostic assessments to help target remediation
  • Cumulative exams to encourage information retrieval and re-encoding

Effective Implementation, Review, and Revision

Finally, prosecutors are asked to consider whether a compliance program is a “paper program, or one implemented, reviewed, and revised, as appropriate in an effective manner.” This holds true not just for the program in general, but for the compliance training curriculum. Just as the corporation should “provide for a staff sufficient to audit, document, and analyze the results of the efforts,” the proper resources and time need to be dedicated to the evaluation of the current curriculum, with subsequent modifications conducted accordingly.

The DOJ’s Evaluation of Corporate Compliance Programs document refers to a compliance program’s capacity to evolve as a hallmark of its effectiveness. That evolution is necessary because “a company’s business changes over time, as do the environments in which it operates, the nature of its customers, the laws that govern its actions, and the applicable industry standards.” An effective life sciences compliance training curriculum must align the current business with the environment, customers, and laws, and now is the time to bring all of those components together.

I hope the insights above are helpful as you continue to improve your compliance training effectiveness throughout 2020. Thanks for reading!

 

What I Heard at the 20th Annual Pharmaceutical and Medical Device Life Sciences Compliance Congress…and What It Means for Your Compliance Training!

Dan O’Connor of PharmaCertify and a panel of industry leaders share their experiences during the training workshop at this year’s Pharmaceutical and Medical Device Compliance Congress.

Presenters at this year’s Life Sciences Compliance Congress from the Pharmaceutical Compliance Forum (PCF) covered some of the same ground as previous conferences (tone at the top, sharing resources, mine the data, etc.) while mixing in a significant amount of new content and thought-provoking ideas for the attendees to consider. PCF even added an impressive amount of “mini-summits” to the agenda to ensure the content appealed to compliance professionals dealing with a variety of risks. It was a challenging, yet worthwhile, amount of information to absorb.

Following are some of the more interesting ideas shared at the conference, along with thoughts on what they mean for the compliance industry and for anyone interested in building and maintaining a successful compliance program.

  1. “Don’t worry about developing a culture of compliance, develop a culture of integrity instead.”
    The idea of making compliance concepts more relatable or understandable is nothing new and it was discussed extensively during this year’s Chief Compliance Officer Roundtable. According to the presenters, employees understand “integrity” more than they understand building a “culture of compliance.” The panelists offered examples of how they strive to integrate the concept of integrity throughout the company – from annual integrity awards, to asking every employee to write how they model integrity and ethical behavior in their daily business activities. As they put it, “don’t make it a compliance policy issue, make it an integrity issue.”
  2. “Don’t underestimate the ability of people to rationalize.”
    The life sciences industry holds the potential to “alleviate pain, restore health, and extend life.” While that is a noble responsibility, it holds the potential for dangerous rationalization. It’s too easy to think, “since we are saving lives, I need to get this product out faster…so I need to make this sale as quickly as possible,” or “I know my product is better than the competition, so I need to do whatever is needed to make the sale.” Continuous training is needed to instill a sense of responsibility in learners and help guard against the dangers of rationalization.
  3. “If you don’t get access to the Board as a member of the compliance team, that company is not a place you want to be.”
    Surprisingly, this one came from the AUSA Roundtable. I did not expect to hear career advice offered by a group of Assistant U.S. Attorneys, but it reinforces the notion that the compliance department must be integrated into the entire company, top to bottom, to be effective. It was a theme carried throughout the conference and led to compelling debates around topics like whether the compliance department should report to the legal department (hint: most regulators prefer to see it having the clout that comes with being a standalone department).
  4. “The shift to a patient-centered business model comes with risk.”
    During the session on “charitable contributions compliance considerations,” panelists focused on the need to avoid any suggestion that support programs and assistance programs are being used to increase sales. The separation between more sales and making products available to more patients is a fine line. As was also mentioned (and most industry insiders know), the list of Corporate Integrity Agreements (CIAs) focused on donations is growing. Panelists stressed the need to be careful about “where the charitable money is coming from.” If it comes from the commercial budget, it will be considered a commercial payment.
  5. “Communication style and protocol is key when dealing with co-pay foundations.”
    During the Helping Patient Access to Products session, presenters raised surprising points about the nuances of communication. As an example, “smiley face icons” in emails may seem innocuous, but they need to be avoided not only for general inappropriateness purposes, and because they hold the potential to be misleading during an investigation. Does that “wink” imply a favor or quid pro quo? The key throughout all communication is to avoid any suggestion that a support program is being used to overcome a co-pay barrier.
  6. “International cooperation across policing agencies continues to increase.”
    According to the presenters in the US DOJ and US SEC Update on FCPA Enforcement session, they are seeing a growing number of referrals from overseas regulatory bodies – significantly more than they saw ten years ago. Risk is rising, as are the number of whistleblower cases, and the panelists encouraged audience members to carefully review the DOJ’s April 2019 Evaluation of Corporate Compliance Programs document for what the agency considers to be the best practices for building and maintaining an effective program and reducing risk.
  7. “The lack of understanding between pharmaceutical sampling and medical device sampling is like day and night, and that makes it complicated.”
    Much of the Annual Medical Device Roundtable was understandably dedicated to the challenges associated with “asset management.” Consider that every missing, or unaccounted for, device could be considered a kickback during an investigation.  As one panelist emphasized, “the government has zero tolerance for asset management problems.” Another raised the interesting point that companies must ensure they are loaning devices to HCPs for the right reasons, and not because those HCPs want “to replace a machine that is currently not functioning” or “to use it for one test.”
  8. “Sharing resources can become political. Your initiatives may get pushed back when budgets are tightened.”
    The sessions dedicated to compliance for small to mid-sized businesses always provide unique insight to those attendees faced with limited resources and budget and this conference was no exception. The idea of reaching out to other areas of the company for support is a common refrain, and the added twist of what happens when budgets tighten was thought provoking. As the presenters explained, when compliance is a priority with corporate and with the Board, fighting that pushback gets easier. Tone at the top may be a bit cliché, but it’s a powerful weapon in the battle for time and money.
  9. “A corporate integrity agreement can be an opportunity to improve your overall compliance program.”
    Dreading the thought of a CIA is understandable, but the five years spent abiding by the terms of the settlement provides the momentum to build up a budget and showcase the importance of the program. Buy-in from corporate on resources is automatic during the CIA and it serves as the blueprint for what can be accomplished moving forward. Exiting the CIA is the time to evaluate lessons learned and evaluate methods for making the compliance program even stronger. From a training standpoint, the end of a CIA is also the time to evaluate what mandated programs were successful and explore opportunities to deploy more targeted, role-based training.
  10. “Your risk assessment needs to guide your monitoring and make it more meaningful.” This is actually a hybrid of statements made by Mary Riordan of the Office of Inspector General (OIG) during her much-anticipated annual speech and multiple presenters throughout the two days of presentations. The bottom line: a successful compliance program cannot be a cookie cutter effort, replicated from one company to another. Risks assessments need to be conducted at least on an annual basis and every aspect of the compliance program, including training, should be evaluated and modified accordingly. Continuous improvement is needed to make it meaningful and relevant.

What Else Does It Means for Your Compliance Training?

Whether you work in the pharmaceutical or medical device industry, the world of compliance is evolving, and the design and delivery of training must evolve as well. Based on the information shared in the OIG, DOJ, and AUSA sessions, the guidelines for who receives what training, at what frequency, needs to be enhanced.

As an example, during the session on reducing risk using a portfolio approach to compliance training, panelists discussed the need to integrate contextual reminders like vis aids, static prompts like intranet banners and poster, and active prompts like emails and desk drops to more effectively change behavior and facilitate a shift to that “culture of integrity.” The need to “make compliance training stick” is growing and now is the time to reevaluate your training curriculum and delivery methods.

Thanks for reading, I hope to see you at the “21” Annual Pharmaceutical and Medical Device Compliance Congress in 2020!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

A Preview of the 10th Annual Life Sciences West Coast Compliance Congress

CBI’s West Coast Compliance Congress is scheduled for Tuesday, October 22nd through Thursday, October 24th in San Francisco, and a review of the pre-conference agenda reveals a compelling mix of panel presentations and master classes focused on the most pressing challenges facing life sciences compliance professionals. Here are the sessions we have noted as most intriguing.

Tuesday, October 22, 2019: Pre-Conference

Attendees face an interesting choice right from the start of the conference with two Pre-Conference Summits scheduled simultaneously for 1:30 – 5:00 on Tuesday. Both are focused on topics critically important considering recent industry settlements.

During Summit A, Patient Assistance and Support Programs – Ensuring Patient Centricity Through Compliant Frameworks, summit leaders, Terra Buckley of Celgene, Daryl Kreml of Sage Therapeutics, and Kari Loeser of Relypsa will delve into the risks associated with assistance programs, hub services, nurse educator programs, and reimbursement services. It’s a comprehensive look at the topic by an impressive group of panelists. Don’t miss it.

In fact, the only valid reason to miss Summit A may be to take in Summit B: Third-Party Risks and Oversight – Innovative Models Driving Compliance. The increasing trend toward outsourcing services in the life sciences industry has led to the need for even greater diligence around the selection and management of third-party vendors. According to the agenda, representatives from Advanced Bionics, Merck, and Varian Medical Systems will “share best practices, uncover red flags and set a tactical plan for enhancing oversight.”

Wednesday, October 23, 2019: Day 1

After opening remarks by Erik Atkinsson of Cytokinetics, Day 1 begins with a session intriguingly titled, Trailblazer Talk. Averi Price of Radius Health, Sharon Delshad of Nalpropion Pharmaceuticals, and Daryl Kreml of Sage Therapeutics will focus on “adapting and evolving compliance programs in support of innovation.” I expect it to be an enlightening program from three highly-regarded industry veterans.

When attending any compliance conference, I make a note not to miss the sessions featuring government prosecutors and regulators. The Current and Former Prosecutor Panel is no exception as former prosecutors Tiffany Mosely of Loeb & Loeb, LLP and Joes Verla Jr. of Bass, Berry & Sims will join Adam Reeves from the United States Attorney’s Office in the Northern District of California to discuss trends for next year and beyond. Hearing from the government side always offers important lessons and insights.

Later, on Day 1, the “New Guidance” session subtitled, Walk Through the Evaluation of Corporate Compliance Programs – Foundational Understanding and Future Impact, is compelling based solely on the use of “evaluation” in the title. If this is indeed a step-by-step review of what makes a successful compliance program, the time invested should be more than worthwhile. I wouldn’t miss it.

The afternoon of Day 1 includes two sets of simultaneous “master classes,” beginning at 1:30 with the Transparency and Aggregate Spend session and Data Privacy and Cybersecurity session.  At 2:15, it’s a choice between Promotional Compliance in one session and Non-Promotional Activities in the other. I understand the need to schedule simultaneous sessions to pack as much content as possible into the conference, but it makes for difficult choices. If you are attending with coworkers, I suggest a divide and note-sharing approach to maximize the opportunity.

Day 1 ends with a networking wine and cheese reception, which may be your best opportunity to network with peers and industry leaders. This makes for a great exchange of tips, suggestions, best practices, and business cards.

Thursday, October 24, 2019: Day 2

Day 2 opens with two concurrent master classes at 8:30 and two more at 9:30. The HCP Engagement and Contracting – Mitigate Compliance Risk and Improve Operational Efficiency session stands out as one I would not miss considering the current regulatory focus in that area.

Speaking of HCP contracts and current regulatory focus, the in-conference workshop at 10:45, Strengthen Speaker Program Compliance Through Innovative Initiatives and Best Practices is certainly worthy of an asterisk in your agenda. And if speaker programs are high on your list of risk areas, we now offer a Compliance Foundations™ eLearning module titled, Managing Speaker Program Risk. The 30-minute module covers topics like program planning, speaker compensation, attendee management, and speaker responsibilities, to list just a few. And it’s easily customized with your specific policies and contact information. Let me know if you’d like to a content outline.

Before the conference closes with an Exclusive Benchmarking Think-Tank, Greg Moss of Kadmon Holdings, Sunita Ramamurthy from Loxo Oncology, and L. Kathleen Durousseau of Rigel Pharmaceuticals will cover Governance Best Practices and Working with the Board. We often hear about the importance of “tone from the top” at compliance conferences and any discussion centered on ideas for working with the board to establish the proper tone is worthwhile. It’s a strong topic for the end of the conference.

Thanks for reading this preview of the 10th Annual Life Sciences West Coast Compliance Congress. As always, I welcome your comments, feedback, and stories from the conference. If you are attending the conference, please say hello to my colleague from PharmaCertify, Dan O’Connor, who will be there as well.

Sean Murphy
Marketing and Product Manager
PharmaCertify by NXLevel Solutions

A Preview of the 5th Annual Life Sciences Compliance Congress for Specialty Products

 

 

Cambridge, Massachusetts, the site of the 5th Annual Compliance Congress for Specialty Products.

The 2019 compliance conference season is just around the corner and the PharmaCertify™ team is gearing up for a slate of sessions beginning with a two-day stop at CBI’s 5th Annual Life Sciences Compliance Congress for Specialty Products.

This conference holds particular interest since the compliance challenges faced by specialty companies, including a number of our clients, are somewhat unique to the industry. With that in mind, I have perused the agenda for the sessions that look compelling for the specialty audience.

Day 1: Thursday, September 12, 2019

8:30 a.m. Keynote Panel: Focal Points and Top Enforcement Trends for Specialty

Set your iPhone alarm and don’t be late for the opening session! The enforcement panels are often a source of valuable information at compliance conferences in general and in light of the focus on specialty biotech companies in this conference, this is an intriguing choice to kick off the conference. Assistant U.S. attorneys from Massachusetts, New York, and New Jersey will join the panel to hopefully discuss the trends specifically relevant to this audience.

11:30 a.m. Creative Training Techniques for Out-of-the-Box Engagement

Okay, I confess, I am a little biased since this session will be moderated by my colleague Dan O’Connor. But being on the “inside” has afforded me the opportunity to hear and see the plans for the presentation and trust me, you don’t want to use this time to refill your coffee. Dan and the panelists from Avanir Pharmaceuticals, Sanofi Genzyme, and Sarepta Therapeutics will share real-world and tested techniques for creating and deploying training that sticks.

1:15 p.m. Where is the Line? Tackling the Overlap in Medical and Commercial Activities

Understanding the divide between MSLs and sales representatives remains a key topic for training consideration in the pharmaceutical industry in general. And that line does change over time. In fact, presenters at the 16th Annual Pharmaceutical Compliance Congress in April stressed that the recent trend toward a principles-based culture requires even more collaboration between Medical Affairs and Field Sales. Expect the panelists from Radius Health, Sunovion, TESARO, and Akebia to address that change.

2:15 p.m. How Far is Too Far? Navigate the Risks While Maintaining the Merits of Patient Support Activities

Patient support programs are in the news. I know…tell you something you don’t know, right? I find the title of this session interesting though in that it highlights the need for risk awareness while pointing out that the programs hold benefits for the patients that pharmaceutical companies are committed to serving. Keeping those programs compliant is a worthwhile and noble effort and we look forward to the panelists from Sage Therapeutics, Sanofi Genzyme, and Acceleron Pharma sharing their suggestions for accomplishing that task.

5:00 p.m. Networking Wine and Cheese Reception

While this may seem like an obvious choice for a favorite session (somewhat akin to saying “lunch” was my favorite subject in high school), I make note of it for reasons beyond the libations. The networking sessions at compliance conferences offer a great opportunity to learn from your peers in face-to-face conversations. You’ll even get to chat with the vendors who made the time and financial commitment to share their products and services with you. Don’t forget to stop by the PharmaCertify booth to say hi – the wine is on us! Oh wait…it’s already on CBI.

Day 2: Friday, September 3, 2019

8:30 a.m. The Impact of Recent FDA Guidance on Product Communications – Dramatic Change in Operations or Business as Usual?

After a review of Day 1 by the conference chair, Day 2 begins with this cleverly titled session. I admit, I was pulled in by the title and I’m intrigued to hear the answer. My best guess, based on recent presentations by the FDA’s Office of Prescription Drug Promotion, is that the truth lies somewhere between “dramatic change in operations” and “business as usual.”

11:30 a.m. Cell and Gene Therapies Learning Lab – Compliance Considerations for Highly Complex, Potentially Curative Treatments

While the two “comprehensive breakouts” scheduled for 11:30 a.m. both look intriguing and educational, I lean to this one simply because of the title. After all, what’s better than a specialty pharmaceutical product conference that features discussions about well…specialty pharmaceutical compliance considerations? This is a great example of how such smaller, more focused conferences can present learning opportunities that are rare in the larger compliance congress settings. We look forward to hearing the presenters from EMD Serono and IQVIA discuss how those considerations differ from the broader risks and concerns.

2:00 p.m. Fireside Chat What You Need to Know and What You Wish You Had Known – Compliance for the Beginner and the Expert

Great title!  Described as an interview session with participants from Sage Therapeutics and Acceleron Pharma, this is certainly a unique and bold way to end the conference. Hopefully, it fills attendees’ minds and notebooks with memorable tips, suggestions and reminders to help them build a stronger culture of compliance and reduce risk. Well played, CBI, well played.

Discounted Registration Fee!

As a conference sponsor, the PharmaCertify team is offering a discount registration voucher for the 5th Annual Life Sciences Compliance Congress for Specialty Products. Contact me at smurphy@nxlevelsolutions.com if you’d like to take advantage of this opportunity to network with your peers and hear industry leaders share best practices and tips for building, maintaining, and training on a strong compliance program. While at the conference, stop by the PharmaCertify booth to see demos of our newest Compliance Foundations™ eLearning modules, custom training courses and the newly updated Access LMS.

Thanks for reading!

Sean Murphy
Marketing Manager, PharmaCertify by NXLevel Solutions