005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard

CMC Live - Chemistry, Manufacturing & Controls

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

“You need to be very careful what you’re going to put in a dossier during the product development.” (08:07)

“And that’s where the interaction with the FDA is critical. So, the sooner, the better. You need to be upfront when you go to those meetings with the FDA. However, you don’t ask a question for which you don’t want to hear the answer.” (09:04)

“So, it’s not because you’re going to get a breakthrough or a fast track that you’re going to cut the corner and not have all the appropriate information that is required or expected by the FDA. However, what you could do is do a science-based or some justification that you could propose to the FDA to mitigate the risk and ensure that your product meets always the same quality and strength.” (17:52)

“There are times where, as a consultant, you could provide the best of your knowledge, but then the sponsor will decide, ultimately, what to do and when to do it.” (27:00)

Relevant Links

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Edward Narke on LinkedIn

Catherine Bernard on LinkedIn