[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

American Conference Institute (ACI)
Contact
March 24th - 25th, 2021
8:15 AM - 1:45 PM EDT

Or call 888-224-2480 for fastest service.

Save extra 10% off the current rate by using code D10-999-JDS21.

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation.

Conference Co-Chairs

Kurt R. Karst

Torrey Cope

Kurt R. Karst
Partner
Hyman, Phelps & McNamara, P.C.

Torrey Cope
Partner
Sidley Austin LLP

WHAT TO EXPECT AT THE VIRTUAL FDA BOOT CAMP

Icon

Icon

Icon

Icon

Enjoy an Easy to Use, Dynamic Online Platform.

Immerse Yourself in Live Presentations and Panel Discussions.

Engage in meaningful dialogue with attendees and speakers in an interactive format.

Meet 1:1 with Your Fellow Attendees. Expand your network and make new connections.

Gain essential working knowledge of core FDA concepts, and real-world examples that will help you excel in your everyday practices.

The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. Recent news stories and high-profile trials concerning FDA-regulated products have made it clear that it is critical for attorneys who do not have regulatory practices and life sciences executives who deal with FDA-regulated products to have a familiarity with these concepts.

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
  • Clinical trials for drugs and biologics
  • The role of the Hatch-Waxman Act in the patenting of 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

SPECIAL FOCUS SESSIONS ON

  • Expedited Approvals: Chasing the COVID-19 Vaccine
  • Controlled Substances

Download the Agenda to see the full program including speaker faculty.

Save an extra 10% off the conference by using code D10-999-JDS21.

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

PRESENTED BY:

American Conference Institute (ACI)
Contact
more
less

American Conference Institute (ACI) on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.