American Conference Institute (ACI) will be holding its FDA Boot Camp conference on September 23-24, 2020 as a VIRTUAL conference. The conference will provide attendees with presentations on these topics: • The organization, jurisdiction, functions, and operations of FDA • The essentials of the approval process for drugs and biologics • The role of the Hatch-Waxman Act in the patenting of drugs and biologics • Clinical trials for drugs and biologics • Labeling in the drug and biologics approval process • cGMPs and other manufacturing concerns relative to products liability • Proactive adverse events monitoring and signal detection • Recalls,…
