At PharmaCertify, our mission is to help you reduce risk through better compliance training. The mission of this blog is to provide you with a continuous flow of information to assist you in doing just that. To that end, I have reviewed the agenda for the upcoming Pharmaceutical and Medical Device Ethics and Compliance Congress (October 24-25 in Washington DC) with an eye toward the sessions I believe (and hope) are most likely to offer tips and suggestions to make your training curriculum more effective.
First, a disclaimer: while I know, or at least know of, many of the conference presenters, I am not familiar with the details of their presentations, or to what level they plan to address training. That said, here are the sessions I would put at the top of the list for helping you create better compliance training.
Day 1: Monday, October 24, 2022
9:00 am, MINI SUMMIT 3: New Product Launch Compliance Playbook
For anyone prepping for a product launch, this looks like a can’t miss presentation. (Coincidentally, we recently posted a “Dear Connie the Compliance Training Director” article on this blog with ideas for how to cover the topics necessary to prepare a field team for a launch.) Terra Buckley, who heads up the Compliance Advisory Services team at MedPro, will be joined by Ann Beasley, Chief Compliance Officer at Zai Laboratory. Their combined industry experience and depth of knowledge is sure to make for a session chock full of the content you need to quell the product-launch training jitters.
9:00 am, MINI SUMMIT 4: You Finished Your Risk Assessment…Now What? Practical Approaches to Making Your Results Meaningful
They had me at risk assessment. As followers of this blog can attest, we at PharmaCertify are advocates for designing a training curriculum based on risk. We utilize a process we call the compliance curriculum analysis process (CCAP) to help design a targeted training plan. So, you can see why I am intrigued by the title of this session, since it aligns with our approach. Here’s hoping Christie Camelio of EQRx, Olga Zinavenka from Endo International, and BJ D’Avella, of Paul Hastings delve into the training considerations following a risk assessment.
10:00 am, MINI SUMMIT 5: Social Media — Auditing and Monitoring to Promote Compliance in this Rapidly Evolving Landscape
Here’s an anecdotal side note related to social media that highlights why I think this session should be a priority for anyone looking to optimize a compliance training curriculum: I was asked to review client changes to the storyboard for our Compliant Product Promotion eLearning module. The client added a comment on the social media screen of the document noting that her company’s policy does not allow for any product-related posts, even if they are on-label and truthful. Therein lies the problem.
The rules, policies, guidance, and best practices for the use of social media in this industry are constantly changing. You need to keep abreast of those changes and regularly consider how they should be integrated into your own policies, and subsequently, your training curriculum. Stephanie Kurteff of Medicines360, Nikki Reeves from King & Spalding, and Ed Sleeper, who is with HUTCHMED, will present.
11:00 am, MINI SUMMIT 8: New and Emerging Risks for Medical Device
Medical device is in the house! Settlements are on the rise for the medical device industry, and compliance professionals facing the unique risks that accompany the promotion of devices would be wise to join Beth Weinman of Ropes & Gray, Sujata Dayal from Medline Industries, and Katherine Norris of Epsilon Life Sciences for their take on the new risks. If medical devices are your focus, and you want to know what you might be missing in your curriculum, you need to attend this one.
11:00 am, MINI SUMMIT 9: Compliance & Ethics in Emerging Companies
I generally find the sessions focused on the risks facing emerging companies to be among the most valuable from a training standpoint. Compliance professionals from smaller companies face the same challenges as their colleagues from larger companies, with smaller budgets and fewer resources at their disposal. If the “emerging company” shoe figuratively fits your foot, I’m confident you will find the discussion with Kevin Ma from PharmaEssentia, Kristen Oberg from Mycovia Pharmaceuticals, and David Ryan of Epizyme to be helpful, especially (fingers crossed) if they include their suggestions for building effective training with what some might consider a shoestring budget.
1:30 pm, Keynote: US HHS Office of Inspector General Update
If you’ve attended this conference over the years, you won’t be surprised that I’ve added this annual session by Mary Riordan of the OIG to my list. In fact, if I was writing this post by order of priority instead of chronologically, the session would be at the top of the list. Hearing the agency’s workplan for the upcoming year is a great starting point for anyone interested in knowing what topics should be targeted for training. Make it a priority.
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5:45 pm, ADJOURNMENT AND NETWORKING RECEPTION: EXHIBIT HALL
It’s been years since we’ve seen you in the Exhibit Hall! Don’t worry, I blame COVID, not you. But seriously, the reception is one of the best opportunities to mingle with your peers and share success stories for building and maintaining a successful compliance program. It’s also a great time to visit the wonderful vendors and learn the ways they can help you do just that.
The PharmaCertify team will be there (we’ve even got some surprise guests this year), with demos of the foundational, reinforcement, and performance support tools to help you launch better training. Even if it’s just to sa0 hi, stop by the booth! We’re a friendly bunch.
Day 2: Tuesday, October 25, 2022
8:00 am, MINI SUMMIT 13: General Corporate Compliance in an Early-Stage Company and Shared Learnings for Larger Companies
We may have a winner for the best session name for the conference, or at least the most audience-inclusive name. I have to say I am intrigued by the idea of carrying concepts from early-stage companies over to larger companies. While some challenges and risks are shared, some faced in early stages of product development are part in parcel to the limited resources to which they have access. The panel for this session is large and wide-ranging in terms of company size. It includes Rachel Batykefer from Mallinckrodt Pharmaceuticals, David Falcone from Merz Aesthetics, Andrea Kocharyan from Flagship Pioneering, Kirt Kraeuter from Moderna, Rachel Lei of Aldevron, and Kirsten Liston from Rethink Compliance.
9:00 am, MINI SUMMIT 17: The Evolving Transparency Reporting Landscape: Changes in 2022 and Preparing for 2023
I’m thrilled to see transparency reporting on the agenda. For context, we just revised the Compliance Foundations module, Raising Awareness of Global Transparency, and I can understand why the advent of new laws around the world make this a challenging topic for training. Determining who needs to know what, about which law, can be a challenging starting point. Our module covers the general concepts from a high-level, and includes a select list of laws, both established and new. We also include PDF documents related to the other laws in a “resources” section.
Okay, back to the session. Expect Kelly Tope of Takeda and Chelsea Ott from MedPro Systems to cover the relevant regulations in detail and jumpstart your thinking toward an effective approach to transparency training.
11:00 am, MINI SUMMIT 27: Practical Guidance for Building Better Compliance Training
DO NOT MISS THIS ONE! You may think I am biased because the head of PharmaCertify, Dan O’Connor, is leading the panel, but I’ve seen the presentation slides and I am quite familiar with the training samples. Trust me when I say you want to be there. Dan will be joined by Madelyn Archibald of Bioventus, Ryan Bonistalli of Ultragenyx, and Jackie Parris from Incyte, who will share their experiences in designing, developing, and deploying better compliance training.
1:30 pm, CLOSING PLENARY SESSION: US Department of Justice Keynote, FDA Keynote, and AUSA Roundtable
The presentations by current and former government representatives are usually worthwhile because the presenters offer a drastically different perspective than industry professionals. The experience and insights from this group are sure to be of value as they share their expectations for an effective program, and subsequently, a training curriculum.
The Department of Justice keynote, with Fraud Section Chief Glenn Leon, the FDA keynote with Acting Director Catherine Gray, and the AUSA Roundtable with Kelly Begg Lawrence from the District of Massachusetts, Jamie Yavelberg from the Civil Division of the DOJ, and Michael Loucks, of Skadden, Arps, Slate, Meagher & Flom, (and formerly with the District of Massachusetts) should all be considered for that important viewpoint.
Day 3: Wednesday, October 26, 2022
9:15 am, Cardiac Arrest — A CEO Lessons Learned from Surviving a Five-Year Criminal Prosecution
If you’re staying for Day 3, don’t be late! I’m not sure if I can make the connection to an effective training curriculum with this one, but based on this description in the agenda, it could be interesting: Howard Root, former CEO from Vascular Solutions, will share his own experience as he faced down prosecution from the Department of Justice in a whistleblower case and won.
11:25 am, Debrief, Q&A and Best Practice Sharing
Jill Dailey from Incyte, Joshua Marks from Takeda, and Daniel Spicehandler of Stryker will spend the final 35 minutes of the conference summarizing the key points and best practices shared during the first two days. Plan on attending to catch up on what you may have missed from the sessions you may have missed.
Discount Registration
Although it is billed as a “hybrid” event, the 23rd Pharmaceutical and Medical Device Ethics and Compliance Congress represents the first opportunity since the pandemic began for the industry to gather in person to share experiences, best practices, tips, and suggestions for building and maintaining an effective compliance program. While PCF has made every effort to replicate the experience of a live event with recent virtual congresses, the personal interaction and information sharing that occurs during live conferences outweighs an online experience.
If you are interested in attending the conference, we can help with a “friend of faculty” discount for first-time attendees. Please contact us at info@pharmacertify.com if you’d like to take advantage of this opportunity (in-person or online) to hear industry leaders, government representatives, and leading vendors at the discounted rate!
Thanks for reading and don’t forget to visit us at the PharmaCertify booth!