Welcome to another episode of Queens of Quality. Join us in this podcast episode as we decode compliance and quality assurance complexities in the pharmaceutical and biotech industries with Sherice Mills, founder of ADROIT Risk Management. Sherice enlightens us on the evolution of REMS programs, their importance in patient safety, and the role of the FDA. We also delve into the challenges in leadership and innovation in these industries and the need for a partnership mentality for revolutionary ideas. The episode further explores the changing expectations of the FDA from vendors, the impact on patient safety, and the need for trusted advisors. Don't miss out on this informative conversation.
Tune in!
During this episode, you will learn about;
0:00:32 - Guest introduction: Sherry Mills, founder of Adroit Risk Management.
0:01:39 - Discussion about the history and origins of REMS programs.
0:04:14 - Mention of the FDA's authority to require additional safety measures.
0:06:03 - Explanation of the various components of REMS programs.
0:09:12 - Discussion on the challenges of standardizing REMS programs globally.
0:16:33 - Challenges in Leadership and Innovation
0:18:58 - Addressing resistance to change within the pharmaceutical industry.
0:20:23 - Importance of in-house expertise and trusted advisors.
0:24:16 - Reference to the REMS Industry Consortium (RIC) and the need for industry collaboration.
0:27:46 - Mention of upcoming workshops and exploration of AI in the industry.
0:31:56 - Closing remarks and contact information.
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