IMPORTANT NOTICE

Due to the rapidly evolving situation around COVID-19, FDA Boot Camp West Coast Edition has been removed from the calendar until 2021.

We have made this decision out of an abundance of caution given COVID-19 concerns. The safety and security of our attendees, speakers, exhibitors, and staff, remain ACI’s top priority.

The next FDA Boot Camp will be coming to Boston in September and we hope to see you there.



Still interested to attend the West Coast edition? Join our email list to ensure you will receive updates as they become available.

For nearly two decades, ACI’s FDA Boot Camp has been the “go-to” program for pharmaceutical professionals to obtain a core understanding of the fundamentals of FDA law and regulation. Don’t miss your opportunity to join their ranks and attend in: New York, Boston, and now San Francisco.

ACI is pleased to present our Inaugural FDA Boot Camp – West Coast Edition which like its New York and Boston sister events is designed to provide life sciences professionals with a strong working knowledge of core FDA competencies

Attend and learn from a distinguished faculty of leading FDA regulatory authorities – the “who’s who” of the FDA bar, including several former FDA officials, who will help you:

  • MASTER the core competencies of the application and approval processes for drugs and biologics
  • APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
  • GAIN a practical working knowledge of clinical trial process
  • RECOGNIZE the pivotal role of labeling
  • DECIPHER the requirements for advertising, marketing, and promotion of drugs and biologics
  • 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.

Testimonials

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“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

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“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

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“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

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

Timothy Benoit-Ledoux, Legal Counsel
Vapotherm