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

ACI’s FDA Boot Camp returns with a renewed focus to provide individuals working within the pharmaceutical space with the critical regulatory knowledge, core FDA concepts, and real world examples they require to excel in their everyday practices.

 

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.

Highlights from this year’s program include an up-to-the-minute “Ripped from the Headlines” section covering recent hot issues such as the FDARA, the states attempts to affect drug pricing, and the potential effects of the mid-term elections on federal legislation and FDA regulations.

 


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

 


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

 


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.

 
 

Our Prior Delegates Say it Best:

“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

JOIN US FOR THE PRE AND POST CONFERENCE WORKSHOPS:

September 26th, 2018:
A | FDA Law 101: Introduction to the Fundamentals
B | Resolving Ethical Challenges Encountered during the Drug Approval Process

September 28th, 2018:
C | Skill Session: Tips and Strategies for Communicating with the FDA

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 1 – 3, 2018
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:
Marc Gerstein
Tel: 212.352.3220 ext. 5530
[email protected]