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
Your Site’s Background Check is Illegally Incomplete - Here is why
Use Left/Right to seek, Home/End to jump to start or end. Hold shift to jump forward or backward.
In this episode, Darshan Kulkarni dives into the terrifying reality of compliance failures at clinical trial sites. While most directors worry about standard fines, the true danger lies in the "off-the-book" penalties and the looming threat of criminal prosecution for employing excluded physicians. If you aren't auditing your lists correctly, you aren't just risking a citation—you're risking your entire career.
www.kulkarnilawfirm.com
If you are a clinical trial site, you must have a process of checking these lists to ensure that you are not employing or retaining or contracting with physicians who are on any of these lists. Then there are civil penalties and criminal prosecution, all of which needs to be considered.
SPEAKER_01It's also important to recognize that there are some other alternatives, other penalties that may be imposed that are not strictly by the book. And what I mean by that is
