RAPS's Biologics CMC workshop series returns with a virtual, two-day session on phase-appropriate CMC development — the regulatory expectations that shift as a biologic or biosimilar moves from early characterization through licensure.
Dates and format
- Dates: 1–2 October 2026
- Format: virtual workshop
- Organizer: Regulatory Affairs Professionals Society (RAPS)
- Series: a recurring RAPS workshop title, distinct from earlier 2025 and April 2026 editions
What it covers
The workshop walks phase-appropriate regulatory agency expectations for biologics and biosimilars — how much characterization, specification-setting and process validation a submission needs at each stage of development, from first-in-human through licensure — and best practices for building a CMC regulatory strategy that holds up across that lifecycle.
Who should attend
RA/QA professionals, regulatory managers and development scientists who own or contribute to biologics CMC dossiers. The framing is practical rather than introductory: teams deciding how much testing a given development phase actually requires, and how to defend that judgment to a reviewer, are the intended audience.
Looking at other October options? RAPS's Cybersecurity Unauthorized workshop runs later the same month, and cell and gene teams may also want Advanced Therapies Week 2027 in January. The full events directory lists everything we have verified.
Frequently asked questions
When is the RAPS Biologics CMC: Phase Appropriate Development workshop?
1-2 October 2026, delivered virtually. RAPS runs this workshop title periodically; this is the October 2026 edition, distinct from earlier 2025 and April 2026 editions.
Who should attend?
RA/QA professionals, managers and development scientists responsible for biopharmaceutical CMC development and dossier preparation, per RAPS's own description of the workshop.
Is this workshop free?
No — RAPS workshops are paid, member/non-member priced events. Current pricing for this specific October 2026 date was not confirmed from the sources reviewed for this listing; check the RAPS registration page for current rates.
Is this the same session as RAPS's April 2026 Biologics CMC workshop?
No. RAPS runs this workshop title as a recurring series with separate editions and separate registration pages; this listing covers only the 1-2 October 2026 edition.
Sources & further reading
- RAPS. Workshop — Biologics CMC: Phase Appropriate Development, 1-2 October 2026. raps.org
Event details are published by the organizer and can change. This listing was verified via WebSearch cross-corroboration rather than a direct fetch of the organizer's page, disclosed above. Confirm dates, format and pricing with RAPS before registering. Last verified 7 August 2026.
