Combination products — drug-device and cell/gene-therapy delivery systems alike — sit across regulatory frameworks that were not built for them, and RAPS runs this live online workshop, , 10 a.m.–1 p.m. ET, to work through where that leaves current development programs.
Date and format
- Date: 19 November 2026, 10 a.m.–1 p.m. EST
- Format: live virtual workshop, case studies and panel discussion
- Organizer: Regulatory Affairs Professionals Society (RAPS)
- Registration pricing was not stated in the sources checked at our last verification — registration runs through raps.org
What it covers
The session works through the future regulatory framework for unmet medical needs and next-generation drug-delivery devices, using case studies and a panel discussion rather than a lecture format. RAPS positions the learning outcomes around analyzing current regulatory expectations, understanding emerging innovation platforms, and following global convergence and harmonization efforts for combination products — an area RAPS notes will require close industry collaboration to resolve its regulatory, clinical and technical challenges.
Who should attend
Regulatory strategy leads on combination-product and cATMP programs, device and drug-delivery engineers navigating primary-mode-of-action questions, and quality professionals who need FDA's current thinking direct from agency leadership rather than filtered through guidance documents alone.
Tracking sterile-manufacturing science too? The PDA Pharmaceutical Microbiology Conference runs the same season, and the full events directory lists everything we have verified.
Frequently asked questions
When is the RAPS combination products workshop?
19 November 2026, 10:00 a.m.-1:00 p.m. EST, live online, per RAPS's own event listing.
What does the workshop cover?
Case studies and a panel discussion on the regulatory framework for complex devices, cell and gene therapy combination products (cATMPs), and next-generation drug-delivery devices, including global convergence and harmonization efforts.
Who speaks at the workshop?
RAPS describes speakers including FDA leadership and industry specialists with combination-product development and regulatory-strategy experience; individual names were not published in the sources checked.
Is there a cost to attend?
This listing was verified via search-engine corroboration rather than a direct fetch of RAPS's registration page, and pricing was not surfaced in that process — confirm current pricing on RAPS's own event page before registering.
Sources & further reading
- RAPS. Workshop: Navigating Regulatory Challenges for Complex Devices, cATMPs, and Combination Products Delivery — event listing, November 2026. raps.org
Event details are published by the organizer and can change. This listing was verified via WebSearch cross-corroboration of RAPS's own event-page text rather than a direct fetch, because this session's network egress could not reach raps.org directly — confirm date, time and registration with RAPS before making plans. Last verified 1 August 2026.
