FDA as a Development Partner: A New Approach to Product Review Meetings – Webinar Recording/Transcript
Product Details
The best way to sidestep pitfalls in a drug product’s development is to anticipate the questions you’ll get from the FDA during product review meetings. But the FDA isn’t an adversary, it can be just as important to view these review meetings as opportunities to partner with the agency.
In this presentation, you will gain insights from three experts who have successfully worked with sponsors and regulators to advance products from pre-clinical through clinical development, regulatory submission and approval.
Learn best practices for interacting with the FDA and other global regulators in meetings at the different review stages, and how you can be proactive in planning to ensure a timely review and — if all goes well — approval of your product.
Presentation Takeaways:
In preparation for a product meeting with the FDA, you’ll develop a gameplan that:
- Defines the purpose of the meeting(s)
- Shows the value of preparation and rehearsing before meetings
- Understands the process at every stage of the product journey
- Adheres to timelines to ensure success
Take this time to learn best practices from experts to ensure you’ll have successful interactions with the agency’s reviewers.
Meet Your Presenters
Mark Lane is vice president of Development Consulting and Scientific Affairs at PharmaLex, a regulatory consulting group that serves the pharmaceutical, biotech and medical device industry. An expert in global drug development, Mark has over 30 years of experience at some of the world’s leading institutions and companies including the National Institutes of Health, Merck, Wyeth, MedImmune and GE Healthcare, among others.
Anna Perelka, director of Regulatory Affairs U.S. at PharmaLex, is a regulatory strategy expert for initial filings. She also supports product lifecycle activities.
Patrick Larcier, senior director of Strategy Product Development Solutions, EU and U.S. at PharmaLex, has significant experience in the development of biologics, therapeutic and prophylactic vaccines and IVDs/companion diagnostic tests, specifically in the areas of oncology, auto-immune disorders and infectious diseases.
Who Will Benefit
- Regulatory Affairs/Operations staff
- R&D staff
- Clinical Development staff
- Cell and Gene Therapy researchers
- Medical Officers