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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 PricingThe Industry’s Most Trusted FDA Training – Essential in a Rapidly-Shifting Regulatory Climate
With FDA rolling out AI-enabled device and PCCP guidances, recalibrating its stance on LDT oversight after court challenges, and issuing a wave of enforcement activity around GLP-1 compounding, telehealth promotion, and drug/device advertising, regulatory expectations are moving quickly and leaving less room for guesswork.
At ACI’s 45th FDA Boot Camp, life sciences counsel and industry executives get a clear, grounded framework for how FDA is operating right now, so you can navigate approvals, labeling and promotion, quality and safety expectations, and emerging technologies without overreacting to headlines or underestimating risk.
Over two intensive days, you will:
- Understand how CDER, CBER, CDRH, ORA, and OC fit together and how that structure drives decisions, inspections, and enforcement.
- Interpret the latest developments on AI-enabled products, GLP-1s and compounding, LDTs, cGMP and data integrity, advertising and promotion, and post-market safety – and what they practically mean for your pipeline and portfolio.
- Apply real-world lessons from former FDA officials and leading practitioners through case studies that separate “nice-to-know” from “must-do” in today’s enforcement and policy environment.
You leave with a winning playbook, led by former FDA counsel and built on current FDA expectations, so your team can move faster, spot issues earlier, and defend decisions with confidence in a regulatory landscape that won’t sit still.
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
“The speakers and content were second to none. It was a fantastic experience for me to attend.”
“Very positive. Helpful topic coverage, flagging of issues and current regulatory climate.”
Thank you to our 2026 Sponsors & Partners
Media Partner
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]
