PDA/FDA Joint Regulatory Conference 2026

The PDA/FDA Joint Regulatory Conference is PDA's flagship regulatory forum, co-organised with the U.S. FDA and running for more than three decades. The 2026 edition centres on CGMP and quality systems across the drug-product lifecycle: risk-based manufacturing oversight, facilities and process control, raw materials, and supplier management. It is a podium-and-Q&A conference built around direct FDA-industry dialogue, not an exhibition.

Cold-chain and distribution professionals attend for the regulatory read-out: FDA expectations on quality oversight, data integrity, and post-approval control that set the frame for GDP and temperature-controlled compliance. The FDA speakers here signal the enforcement tone that downstream distribution and cold-chain programmes must align to. There is no dedicated cold-chain track; the value is the regulatory signal rather than stream-specific content.

The room is FDA reviewers and investigators alongside pharma and biologics quality, regulatory-affairs, and compliance leaders, largely director-to-VP level from manufacturers, CDMOs, and consultancies. Attendance skews US regulatory and quality practitioners rather than logistics or cold-chain operators.