The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 36th iteration – is scheduled to take place from March 24-25, 2021 (Eastern Time). The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. And like a lot of conferences over the past year, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference.
ACI’s FDA Boot Camp will provide you not only with the essential background in FDA regulatory law to help you in your practice, but also key sessions that show you how this regulatory knowledge can be applied to situations you encounter in real life. A distinguished cast of presenters will share their knowledge and provide critical insights on a host of topics, including:
- The organization, jurisdiction, functions, and operations of FDA
- The essentials of the approval process for drugs and biologics
- Clinical trials for drugs and biologics
- The role of the Hatch-Waxman Act in the patenting of 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, product withdrawals, and FDA oversight authority
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst is co-chairing the conference and will also present at a session titled “Understanding the Relevance of New FDA Initiatives and Policies and How They May Redefine the Life Sciences Industry in the Aftermath of COVID-19.”
FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-874-874EX05. You can access the conference brochure and sign up for the event here. We look forward to seeing you (virtually, of course) at the conference.