DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
Compliance guru talks practical Insights on Speaker Programs
In this episode, host Darshan Kulkarni speaks with Joseph Keeney about speaker programs in the life sciences industry, exploring practical differences between small and large companies. They highlight that while fundamentals like compliance, pragmatism, and sound business principles apply across organizations, strong mitigating controls and adherence to legal and industry codes are critical.
Joseph explains the importance of engaging with various business units to understand real plans, aligning training programs with compliance needs, and avoiding pitfalls that could trigger violations of federal anti-kickback statutes. He emphasizes careful management of speakers bureau rosters, evaluating the necessity and effectiveness of healthcare professionals (HCPs) on the program, and considering fair market value while avoiding indirect remuneration risks.
The conversation also covers compensation approaches, proper documentation, and the value of third-party partners for benchmarking and compliance review. Joseph stresses that each program should be tailored to the company’s unique needs and highlights the importance of ongoing evaluation, diligence, and oversight.
Reach out to learn more.
www.kulkarnilawfirm.com
