FDA associate Jacqueline Berman will speak at the 19th annual FDA-Orange County Regulatory Affairs Educational Conference. Jackie will participate in a panel discussion focused on how to handle the difficult scientific and legal issues underlying the regulatory, clinical, and quality aspects of due diligence involving biotech products and companies.
Due Diligence: The Regulatory, Quality and Clinical Challenges Posed by Transactions Involving Highly-Regulated Biotech Products and Companies
May 5, 2016 | 10:35 – 11:45 am
Transactions involving FDA-regulated firms or products present unique challenges for professionals less familiar with intricate regulatory, quality, and clinical considerations. This session will explore how to prepare and executive due diligence efforts, how to separate the essential from the “nice to know” when conducting such reviews (particularly with limited resources and subject to tight time lines), and how to organize internal teams to maximize efforts and help management make go/no-go decisions on deals.