Amber Sheriff is a Senior Regulatory Affairs Consultant at Design Space InPharmatics. With more than 32 years of experience, Amber is an expert in regulatory strategies for orphan drug designation, exclusivity, controlled correspondences, and briefing books, to name a few. In this episode, Amber, Ed, Meranda and Brian discuss regulatory pathways in the European Union (EU), the impact Brexit has had on CMC filings, and the advantages and disadvantages of the three defined procedures to obtain approval for products in Europe.
Run time: 33:17mins
Episode 16 - Brexit: What You Need to Know for Drug Development
Video Credit: DSI, a PLG Company
Takeaways:
00:54 – Ed, Brian and Meranda welcome to the show Amber Sheriff who speaks to her background as a regulatory affairs specialist in the pharmaceutical industry and the three procedures for obtaining market authorization in the European Union
06:15 – What CMC drug development looks like in the EU and how it differs from the United States
11:24 – Amber breaks down specifics of the centralized filing procedure in the EU
15:49 – Amber provides insights on the impact of Brexit on CMC filing in the EU
18:40 – Benefits and advantages of a decentralized or mutual recognition procedure
23:28 – Amber speculates on the future of drug regulation, including collaborations between the FDA and the EU
27:57 – Finals thoughts from Amber
31:28 – Ed, Brian and Meranda thank Amber for joining the show
About CMC Live
FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.