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Back by Popular Demand: All Access Pass Now Available
Maximize your FDA Boot Camp experience with full access to all three workshops – at a value-packed rate.
| All Access Pass | Conference + 3 Workshops | $2,795 ($4,495 value) |
| Conference Pass | Conference only | $2,095 |
| Workshop Pass | Individual workshops | $600 each |
Rates increase after October 30.
See PricingMaster FDA Fundamentals. Navigate a New Era of Regulatory Change.
FDA is changing how it reviews products, conducts inspections and enforces compliance. From accelerated approval initiatives and evolving AI oversight to new quality system requirements and heightened scrutiny of drug promotion, life sciences companies and their counsel face a regulatory environment where understanding both the fundamentals and the latest developments has never been more important.
At ACI’s 45th FDA Boot Camp, life sciences attorneys, regulatory professionals and industry executives will gain the essential FDA knowledge and practical insights needed to navigate today’s regulatory landscape. Led by former FDA officials and leading practitioners, this trusted program combines foundational training with a clear assessment of what is changing, what remains constant and what it means for your business.
Leave with more than an understanding of FDA law.
Gain the confidence to engage with the agency, anticipate regulatory challenges, identify risks earlier and make better-informed decisions throughout the product lifecycle.
Over two intensive days, you will:
Understand how FDA operates today, including the roles of CDER, CBER, CDRH, OII and the Office of the Commissioner, and how agency structure, authority and policy shape regulatory decisions.
Master the essential FDA frameworks governing drug and biologic approvals, clinical trials, patents and exclusivities, labeling and promotion, manufacturing and quality systems, post-market safety, inspections and enforcement.
Put the latest regulatory developments into practice, including expedited review initiatives, AI-enabled technologies, medical device oversight, QMSR implementation and evolving enforcement priorities, through real-world examples and guidance from former FDA counsel.
Who Attends?
This event is designed for professionals involved in navigating FDA regulatory law in real-world settings. Our audience includes:
- In-house legal teams from leading pharmaceutical, biotechnology, medical device, and diagnostics companies
- Corporate counsel, general counsel, and regulatory affairs leaders responsible for compliance and product lifecycle management
- Partners and associates from top law firms focused on FDA, intellectual property, and life sciences litigation
- Strategic advisors and investment professionals involved in funding or advising FDA-regulated businesses
Past Attending Organizations
Attendees represent companies across the U.S. and globally, including AbbVie, GSK, Merck, Vertex, Novo Nordisk, Regeneron, and dozens more.
Whether you’re an experienced advisor or new to FDA matters, this is your opportunity to build fluency in the concepts, laws, and enforcement trends shaping the life sciences landscape.
CLE Accreditation
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as non-transitional for the purposes of CLE accreditation. Workshop A contains 2 substantive credits and 1 ethics credit. Workshops B and C provide 3 credits each. And the main conference provides a total of 11 hours and 15 minutes of CLE credits.
Learn more
Testimonials
“The speakers and content were second to none. It was a fantastic experience for me to attend.”—Senior Counsel, GSK
“Very positive. Helpful topic coverage, flagging of issues and current regulatory climate.”—Corporate Counsel, Ulrey
Thank you to our 2026 Sponsors & Partners
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Sponsor Opportunities
With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, the Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.
For more information please contact:
Aaron Goldstein
Senior Business Development Manager
Email: [email protected]
