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, product withdrawals, and FDA oversight authority
The conference presentations will be group into the Pre-Approval and Approval Process; FDA Review and Approval; IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More; Post-Approval; Advertising, Promotions, and Related First Amendment Concerns.
Co-Chairs Kurt K. Karst of Hyman, Phelps, McNamara PC and Rebecca K. Wood of Sidley Austin will speak on "Understanding the Relevance of New FDA Initiatives and Policies and How They May Redefine the Life Sciences Industry in the Aftermath of COVID-19."
In addition, two pre-conference workshops will be offered on September 22, 2020. 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 am, 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 offered on September 24, 2020, entitled "Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group," from 2:45 pm to 6:15 pm.
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 is $1,995 for registration by August 28, 2020 and $2,095 for registration thereafter. The workshops are $600 apiece. Patent Docs readers are entitled to a 10% discount off of the registration fee using discount code D10-806-806FX03. 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 FDA Boot Camp.
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