Obtain the guidance you need to master the difficult area of FDA regulatory law

This premier event is designed to provide professionals working in the life sciences space – such as patent and products litigators, in-house counsel, regulatory affairs specialists, business executives, and investors – a strong working knowledge of core FDA competencies.

 

In addition to providing a “101” training, our updated agenda offers advanced guidance sessions discussing the pathways to approval, a patent and IP overview for pharmaceuticals, post-approval issues, and recalls and withdrawals. In addition, each step of the process comes with strategies to apply this knowledge to real-life situations.


OUR ESTEEMED FACULTY WILL DRILL YOU WITH KNOWLEDGE IN THE BASICS OF FDA LAW AND REGULATION AS THE EXPERTS HELP YOU:

  • COMPREHEND the structure of FDA
  • GAIN a practical working knowledge of clinical trial process for pharmaceutical products
  • MASTER the basics of the application and approval processes for drugs, as well as follow-on products such as ANDA’s and Biosimilars
  • RECOGNIZE the pivotal role of labeling, as well as promotions and off-label communications in drugs and biologics
  • APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
  • UNDERSTAND the importance of cGMPs to the post-approval regulatory process
  • NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls

 

The agenda and speaker list will be available soon.
Stay up-to-date by signing up to receive emails.


OUR PRIOR DELEGATES SAY IT BEST:

“The ACI Boot Camp covers all the basics by the experts. The speakers are what give this conference life.”

Travis Thayer, Sr. Regulatory Associate, Chiesi USA

“This event offers a unique combination of experienced faculty, a comprehensive and up-to-date program, and concise and practical content. For any practitioner in the FDA space who wants to get a powerful learning boost in a compact package, this is a great program to attend.”

Second co-chair, Christopher M. Mikson, Partner, Mayer Brown

“The ACI Boot Camp is the perfect way to learn how to navigate the complexities of the FDA regulatory process that is so critical throughout the life cycle of drugs and biologics.”

Saira Haider, Patent Attorney, Fresenius Kabi

“Excellent conference with talented speakers who hold a wealth of knowledge.”

Timothy Benoit-Ledoux, Legal Counsel, Vapotherm

Don’t miss your opportunity to save with Early Bird rates!

Register now and learn to navigate your way through the regulatory maze that plays such a crucial role to your cases and practice areas.

AGENDA & SPEAKERS LIST COMING SOON!

stay up-to-date by signing up
for email updates

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Event Contacts

For sponsorship opportunities please contact:
American Conference Institute
[email protected]


For media partnership opportunities please contact:
Andrea Sachs
P: 212-352-3220 ext. 5224
[email protected]


For questions about this year’s program/content, or information on how you can speak next year please contact:

Tel: ext.

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