American Conference Institute (ACI) will be holding its 39th Annual FDA Boot Camp conference on September 14-15, 2022 as a VIRTUAL conference.
The conference will provide attendees with presentations on these topics:
• Exploring New FDA Initiatives under Commissioner Robert M. Califf
• Navigating the approval process for drugs and biologics
• Exploring FDA's Expedited Programs with regard to applicability and eligibility
• The Nuances of Obtaining Approval for Controlled Substances
• Clinical Trials for Drugs and Biologics
• Patents and Related IP Protections and Mechanisms
• Hatch-Waxman and BPCIA Essentials, follow-on products and generic entry
• Drugs and Biologics Labeling
• The Role of Current Good Manufacturing Practices (cGMP) in the post-approval process
• Advertising and Promotion for Drugs and Biologics
• Off-label Communications: subtleties and safe zones
• Adverse Events Monitoring, Pharmacovigilence, Risk Management, and Recalls
• FDA Enforcement Authority and Actions
In addition, two pre-conference workshops will be offered on September 13, 2022. The first, entitled "FDA Law 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws," will be offered from 9:00 am to 12:00 pm EST, and the second, entitled "Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations," will be offered from 1:30 pm to 4:30 pm. There will also be a post-conference workshop held from 2:30 pm to 5:30 pm on September 15th entitled "Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group."
A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the conference and all three workshops is $2,495 for registration by September 14, 2022. Registration for the conference alone is $1,795. The workshops are $400 apiece. Patent Docs readers are entitled to a 10% discount off of the registration fee using discount code D10-999-PATENTDOCS. Those interested in registering for the conference can do so here, by e-mailing [email protected], or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's 39th Annual FDA Boot Camp.
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