American Conference Institute (ACI) will be holding its 37th Annual FDA Boot Camp conference on September 29-30, 2021 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 grouped into the Pre-Approval and Approval Process; Patents and Related IP Protections and Mechanisms; Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry; Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process; cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices ("cGMPs") in the Post Approval Process; Advertising, Promotions, And Related First Amendment Concerns; Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls; and Understanding the Scope of FDA Enforcement Authority and Actions.
Co-Chairs Christopher Mikson of DLA Piper LLP and Chad Landmon of Axihn, Veltrop & Harkrider LLP 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 28, 2021. 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 held from 2:30 pm to 5:30 pm on September 30th 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 is $1,595 for registration by July 30, 2021, $1,695 for registration by August 27, 2021, and $1,795 for registration thereafter. The workshops are $600 apiece. ACI is offering an All Access Pass for the conference and all three workshops for $2,095 for registration by July 30, 2021, $2,195 for registration by August 27, 2021, and $2,295 for registration thereafter. Patent Docs readers are entitled to a 10% discount off of the registration fee using discount code D10-806-806GX06. 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 37th Annual FDA Boot Camp.
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