American Conference Institute (ACI) will be holding its 36th Annual FDA Boot Camp on March 24th from 8:15 am to 5:45 pm EST and March 25th from 8:30 am to 1:45 pm EST as a VIRTUAL conference. ACI faculty will give presentations 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, by co-chairs Kurt K. Karst and Torrey Cope;
• Navigating the Approval Process for Drugs and Biologics;
• Exploring FDA's Expedited Review and Approval Programs: Applicability and Eligibility;
• Appreciating the Nuances of the Approval Process for Controlled Substances;
• Clarifying the Clinical Trial Process for Drugs and Biologics;
• 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;
• Discovering the Unique Role of Current Good Manufacturing Practices ("cGMPs") in the Post Approval Process Part 1: Drug and Biologics Advertising and Promotion 101 and Part 2: Exploring the Subtleties and Safe Zones of Off-Label Communications;
• Preparing for the Worst: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls; and
• Understanding the Scope of FDA Enforcement Authority and Actions.
In addition, there will be two Pre-Conference Workshops on March 23rd. The first, entitled "FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws," which will be held from 9:00 am until noon. The second, entitled "Medical Devices Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations," will be held from 1:30 until 1:40 pm. There will also be a Post-Conference Workshop on March 25th, entitled "Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency."
An agenda for the conference and additional information regarding the workshops can be found here. 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 alone is $1,695 (paid registration by March 5th) or $1,795 for paid registration by March 23rd. Workshop registration is $400 apiece, and there is an All-Access Pass for the conference and all three workshops for $2,095 (paid registration by March 5th) or $2,195 for paid registration by March 23rd. Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-874-874EX06. 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 Inaugural Summit on Women Leaders in IP Law.
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