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.
“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)
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