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

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