[Virtual Event] FDA Boot Camp - September 23rd - 24th, 8:15 am - 12:45 pm EDT

American Conference Institute (ACI)
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September 23rd - 24th, 2020
8:15 AM - 12:45 PM EDT

Or call 888-224-2480 for fastest service.

You can save an extra 10% off the current rate by using code D10-999-JDS20.

NO NEED TO TRAVEL. WE ARE BRINGING THE BOOT CAMP TO YOU VIRTUALLY.

For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully virtual format, with the continued intent of providing these individuals with an essential working knowledge of core FDA concepts, and real world examples that will help them to excel in their everyday practices.

Download the conference brochure here »

LEARN FROM THE MASTERS

A distinguished faculty of top FDA regulatory authorities – a “Who’s Who of the FDA Bar” – will share their knowledge and provide you with critical insights on:

  • 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

MEET 2020 CO-CHAIRS:

Kurt R. Karst
Partner
Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

Rebecca K. Wood
Partner
Sidley Austin LLP (Washington, D.C.)

(Former Chief Counsel, U.S. Food and Drug Administration)

Click here to see the complete list of speakers »

BOOST YOUR FDA REGULATORY IQ: FROM PRE-APPROVAL THROUGH POST-APPROVAL

In addition, our updated agenda offers advanced guidance sessions focusing on new approval requirements under FDARA and the 21st Century Cures Act, advertising and promotion guidelines for pharmaceuticals and biologics, and a look at the latest initiatives and policies of the FDA.

Don’t miss the pre-and-post conference workshops:

Sept. 22 Workshop A — A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

Sept. 22 Workshop B — Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations

Sept. 24 Workshop C — Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

REGISTER NOW and save an extra 10% off the conference by using code D10-999-JDS20.

*Discount is valid for new registration only and it’s not applicable for workshops.

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American Conference Institute (ACI)
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