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
No more lawyers in PRC?
In this episode we're joined by Heather McFalls, Director of Promotion Compliance at Otsuka Pharmaceutical Companies to discuss the evolving role of ad promo executives and the regulatory landscape in the pharmaceutical industry. Dive into the conversation as we explore the impact of regulatory bodies like the FDA, FTC, and NAD, and the importance of compliance in avoiding legal pitfalls. Plus, learn valuable insights on the role of legal and compliance in navigating the complexities of ad promo. Don't miss out on this enlightening discussion!
Points discussed:
1. How has the concept of regulatory evolved?
2. Is legal essential in MLR?
3. How do we define the roles of legal, compliance, and regulatory?
4. How does a company's history and risk tolerance affect PRC committee interactions?
5. How much flexibility should be given to regulatory consultants?
6. How to manage pushback within PRC team dynamics?
