The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 35th iteration – is scheduled to take place from March 24- 25, 2020 at DoubleTree By Hilton Metropolitan, New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.
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, including: INDs, NDAs, BLAs, OTC Approval, the PMA process and the Expedited Approval Process
- Clinical trials for drugs and biologics
- Unique Considerations in the approval of combination products, companion diagnostics, and stem cell therapies
- The role of the Hatch-Waxman Amendments in the patenting of drugs and biologics
- Labeling in the drug and biologics approval process
- cGMPs, adverse events monitoring, risk management and recalls
In addition—and new for 2020—are special focus sessions on:
- FDA’s Digital Health Initiatives
- Opioid and Other Controlled Substances Classifications
Hyman, Phelps & McNamara, P.C.’s Suchira Ghosh will lead a workshop titled “Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group.”
FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-874-874DX01. You can access the conference brochure and sign up for the event here. We look forward to seeing you at the conference.