Now in its 30th iteration, FDA Boot Camp is the premier event that will provide you with the ultimate roadmap to the complicated landscape of FDA regulatory law

This year’s FDA Boot Camp will provide you not only with the essential background in FDA regulatory law to help you in your practice, but also the key sessions that show you how this knowledge can be applied to situations you encounter in real life.

 

Preeminent members of the nation’s Food and Drug bar will drill you in the basics of FDA law and regulation as they help you:

 

  • LEARN what to expect during a product meeting with the FDA – NEW FOR THIS YEAR!
  • MASTER the basics of the application and approval processes for drugs and biologics
  • COMPREHEND the structure of the FDA
  • DEVELOP a practical working knowledge of clinical trials for drugs and biologics
  • APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
  • RECOGNIZE the pivotal role of labeling in the drug and biologics approval process
  • SEE the importance of cGMPs to the post-approval regulatory process
  • NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls

 

Download this year’s brochure now

 

BE PART OF ACI’S LIFE SCIENCES COMMUNITY!

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PAST ATTENDEES INCLUDED…

1400+

In-House General Counsel, Head of IP, Directors of IP, Patents and Legal Affairs, VP of Patents, IP Counsel, IP/Patent Managers, Head of Regulatory, Regulatory Affairs Managers, Private Practice Lawyers and Patent Attorneys, and many more.

 
 

As our long-time speaker and past co-chair, Geoffrey Levitt, Senior Vice President and Associate General Counsel for Regulatory, Environmental and Global Supply at Pfizer, explains why FDA Boot Camp has remained such a draw for over a decade:

“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 at 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
“Conference offered a lot of good information.”
 

Attend the workshops to get the background and/or in-depth information you need to maximize your learning and networking experience at this event!

 

 

 

 

WE LOOK FORWARD TO SEEING YOU IN BOSTON THIS SEPTEMBER!
 

You may also be interested in:

Paragraph IV Disputes Master Symposium
Master the Necessary Skills to Rise to the Newfound Challenges of the Pharmaceutical Patent Endgame

October 2 - 3, 2017
Chicago, IL

Event Contacts

For sponsorship opportunities please contact:
Esther Fleischhacker
Tel: 212-352-3220 x5232
[email protected]


For media partnership opportunities please contact:
Linda Lam
Tel: 212-352-3220 ext. 5538
[email protected]


For questions about this year’s program/content, or information on how you can speak next year please contact:
Alma Subasic
Tel: 212.352.3220 ext. 5531
[email protected]


Venue

Omni Parker House

60 School Street, Boston, MA 02108
1-800-THE-OMNI

Accommodations:

The American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a preferential rate. To book a room at the discounted rate please call the number below and mention “ACI’ FDA Boot Camp” Alternatively, delegates can book online via the link below.

Room rate: $299.00+tax
Room Cut-off: August 23, 2017

Book