Compliance 101-Most common issues and MSL-related gray areas

In this episode, Jessica McLin and Melody Davis explore the intricacies of compliance and communication in medical affairs. Jessica shares her journey into entrepreneurship and discusses her work with Versant Learning Solutions. The conversation covers FDA standards, ethical collaboration with sales reps, and the importance of understanding company SOPs. They delve into strategies for navigating compliance gray areas and the role of training, especially in smaller companies. The episode also highlights the significance of professional development through conferences and the importance of leadership in enforcing compliance. Finally, they address key compliance rules and best practices for MSLs, including the Sunshine Act.

Today’s guests are Jessica McLin and Melody Davis of Versant Learning. We discuss MSL Compliance 101 and the most common issues and MSL-related gray areas.

In this episode we discuss:

• Jessica and Melody intro


• What Versant Learning does


• Compliance and what people need to know


• The most common gray areas to look out for


• Where can an MSL find compliance information outside their current organization


• The role of MSL Leadership in communicating compliance standards and how much of the effort lies on the MSL


• The most important for the MSLs to keep in mind

(0:00) Introduction of guests Jessica McClint and Melody Davis
(1:15) Guest backgrounds and Jessica's transition to entrepreneurship
(5:24) Overview of Versant Learning Solutions and medical communications
(6:15) Compliance in medical affairs and FDA standards
(8:35) Collaboration with sales reps and ethical considerations
(10:25) Understanding company SOPs and compliance training innovations
(12:58) Navigating gray areas in MSL compliance
(16:06) Communication strategies: Proactive vs reactive
(20:48) Role of compliance training and resources for smaller companies
(24:02) Professional development for MSLs through conferences and education
(27:09) Leadership and compliance enforcement
(31:06) Conducting internal vs. external audits
(31:50) Recording MSL interactions and compliance best practices
(35:55) Key compliance rules for MSLs and Sunshine Act navigation