The NXLevel Compliance team is back from this year’s Pharmaceutical Compliance Congress, where, as predicted, AI was a popular topic and discussions with industry experts reminded us why Compliance should continue having a seat at the table. Here are some reminders and key takeaways from PCC 2024!

AI has landed. While no two companies are embracing and implementing AI in the same way, there is no question that AI is transforming work as we know it and compliance teams are rushing to keep up. Just as we’ve seen with other game-changing technologies, companies are progressively opening the door to greater AI use, which means their policies and training must evolve at the same pace. With AI’s wide-ranging impact, it’s important not to rely on a single training event and instead employ multiple learning channels (such as eLearning, microlearning, videos, job aids, etc.) to instill and reinforce a culture of responsible and compliant AI use.

Compliance applies to everyone. Whether you are a large-scale global company marketing approved products or a smaller scale company with products pending approval, compliance should be at the forefront of your organization. And you need to ensure that your compliance training program meets the needs of your whole organization. While commercial field teams certainly engage in high-risk activities, don’t neglect other members of the organization who may not be as aware of the compliance risks they face.

Social media is still a trending topic. Like AI, the use of social media is constantly evolving. Is your policy up to date? Have you trained your employees on this policy? Your employees need to know the proper ways they may engage with your company’s social media content and the guidelines they must follow regarding their personal use of social media. What can they like, share, or comment on? As we commented on in an earlier post, social media training needs to be rich with examples and help employees understand how their social media behavior can add to their company’s compliance risk.

Keep your training on target. As you may know, the OIG’s General Compliance Program Guidance explicitly states that compliance officers should develop annual training plans that include the training topics to be delivered and the target audience for each topic. While certain training must be delivered company-wide, your training does not always have to be “one size fits all.” When possible, tailor your training to the individual receiving it. And remember, employees are looking for shorter, impactful, and relevant training.

Stay aligned with new and emerging enforcement trends and risk areas. Is your training keeping up with the current compliance landscape? Here are some topics we consistently heard about at PCC:

• Off-label promotion: Pay attention to social media and other digital content that may not undergo a formal review and approval process.
• Clinical trial transparency and oversight: Ensure your clinical trial communications contain substantiated claims and truthful, accurate data.
• Kickback and inducements: Be aware of the implications regarding charitable copays and charitable activities involving patient access programs (PAPs).
• Data privacy and cybersecurity: Keep patient health data and sensitive information protected.
• Market access and patient support programs: Monitor your programs to ensure they are operating as intended.

2025 will be here before you know it. Those are just some insights we gathered from this years’ PCC, and we are already looking forward to next year’s event. If you missed us in the exhibit hall and are interested in learning how we can help you reduce your compliance risk, contact us at compliance@nxlevelsolutions.com.

Thanks for reading! See you at the next conference!

We always look forward to the Pharmaceutical Compliance Congress, but never more so than this year with AI becoming such a transformative force in the life sciences industry and beyond. This year’s congress, occurring April 16-18, is being held at a pivotal moment for compliance professionals. And once again, there are hard choices to make, as there are more intriguing sessions than one person can possibly attend. To help you decide which ones to drop in on, here are five sessions that stood out to us when reviewing the agenda.

Day 1: Top Areas of Concern for the Compliance Professional – There are few details for this particular session available right now, but based on the title, the senior compliance professionals on the panel, and it’s prime slot position on Day One, we are eager to find our seats.

Day 1: Enforcement Panel – Critical, Industry-Specific Updates from the Most Active Office’s for the Bio/Pharma and MedTech Industry – This is a unique opportunity to hear about enforcement trends and new risk areas straight from DOJ officials. (And you may want to follow up with the afternoon session on New and Emerging Risk Areas for 2024 and Beyond.)

Day 2: Industry Pioneer Panel – A Look at the Rapid Adoption of AI Across the Life Sciences Sector – This session promises to provide insights on how compliance professionals can help their organizations responsibly adopt AI and mitigate the risks involved. (Once again, there is a complimentary afternoon session on Artificial Intelligence in Life Sciences Compliance.)

Day 3: Industry Case Study: Compliance Training Strategy and Implementation –This is a can’t-miss session for compliance training professionals. Three members of Regeneron’s compliance team will share their experience implementing and executing an effective training strategy. Expect plenty of practical insights.

Day 3: FDA Address –  The conference ends on a high note with a session with Catherine Gray, PharmD, Acting Director, Office of Prescription Drug Promotion, U.S. Food and Drug Administration (FDA). Hear the OPDP’s top priorities from the Director herself, as well as her thoughts on enforcement trends and warning letters.

Special Mention

Day 1: Compliance Training on the Digital Frontier—Okay, we’re biased. NXLevel Compliance Senior VP Dan O’Connor and his panel have put together a session that explores how you can use existing tools and emerging technologies to create a compliance training program that reduces risk while meeting the expectations of all of your employees, no matter where they are on the “digital fluency” spectrum.

These are just some of the exciting programs planned for PCC, and we look forward to seeing many of you there. If we don’t run into you at a session, please stop by and visit us at the NXLevel Compliance booth, where we will be sharing examples of the different kinds of compliance training solutions we can create to help you meet this unique moment in the life sciences industry.

See you in Virginia!