Compliance Considerations in Medical/Commercial Collaborations
Ann Ford, BSN, JD, Marta Sokolowska, PhD, and Claudia Schoenig-Diesing, MD, MSJ
The success of the Medical Affairs function is highly dependent upon the understanding, by its members, of how the regulations surrounding their activities apply and, at the same time, of the commercial implications of their work.
Maintaining this delicate balance is no small task, especially considering the intensified public and regulatory scrutiny applied to the pharmaceutical and medical device industries. Advisory boards are of particular relevance as a strategy for obtaining non-binding but informed guidance on a range of business aspects. As regulatory requirements get tougher and patients, payers and healthcare providers demand more and more diverse clinical data and health outcomes information to prove product value, it is critical that companies balance the value added to their clinical and commercial goals with the compliance with the relevant codes and laws.
In this webinar, we explore two scenarios that can open Medical Affairs up to censure. Scenario one explores participation of commercial team members in Medical Advisory Boards and scenario two looks at the implications of a commercial team member requesting a medical team member to participate in a thought leader meeting.
By participating in this eCademy Webinar, attendees will be better able to:
- Deep dive into regulatory and other guidance on medical/commercial collaborations
- Explore latest updates to laws/regulations governing compliance
- Learn best practices & key considerations when conducting Medical Advisory Boards
- Explore common compliance risks and approaches to mitigate risk and safeguard credibility in scientific exchange