Episode Summary
DS InPharmatics Senior Regulatory Affairs Consultant, Dr. Catherine Bernard joins the show to share her experience in regulatory affairs in the pharmaceutical industry and preparing dossiers associated with CMC. In this episode, Ed, Brian, Meranda and Catherine discuss breakthrough designations, the role of agencies such as the FDA, and future trends in pharmaceutical regulation.
What We Covered
- 03:00 – Dr. Catherine Bernard joins the show to discuss her background in regulatory affairs within the pharmaceutical industry
- 07:35 – Dr. Catherine speaks to some of the challenges associated with preparing a CMC dossier
- 10:38 – Dr. Catherine speaks to the vital role project management plays in submissions and explains realistic timelines and target dates
- 12:58 – Dr. Catherine talks about her experience with breakthrough designations and managing sponsor expectations
- 20:59 – The importance of listening to regulatory agencies such as the FDA
- 29:01 – Future trends in pharmaceutical regulation that Dr. Catherine foresees and one thing the audience doesn’t know about Dr. Catherine
- 32:29 – Ed, Brian and Meranda thank Catherine for joining the show
Tweetable Quotes
Links Mentioned
Design Space InPharmatics – LinkedIn
Design Space InPharmatics – Twitter
Edward Narke on LinkedIn
Catherine Bernard on LinkedIn