The 2nd Cell & Gene Therapy Regulatory Affairs Summit Returns to Washington!
The regulatory landscape for cell and gene therapies (CGTs) is shifting faster than ever. With new FDA leadership at CBER, draft guidance on post-approval CMC requirements, and potency assays under intensified scrutiny, 2025 is already proving to be a pivotal year. At the same time, global agencies are raising the bar, with ANVISA and Health Canada joining harmonization efforts and ICH Q12 implementation advancing across modalities. For regulatory professionals, staying aligned with these changes is critical to accelerating approvals and ensuring therapies reach patients quickly and safely.
The 2nd Cell & Gene Therapy Regulatory Affairs Summit (December 2-4, Washington, D.C.) is the only industry-led event dedicated exclusively to CGT regulatory strategy. Designed for professionals navigating nonclinical, clinical, and CMC submissions, this summit provides a unique forum to benchmark with peers, learn directly from regulators, and explore solutions to the most pressing challenges in CGT development.
Over two days, 80+ experts will share real-world case studies and actionable insights across key focus areas, including:
- FDA & CBER updates – what new leadership means for CGT review and approvals
- CMC strategy – addressing post-approval requirements, comparability, and potency assays under scrutiny
- Global harmonization – aligning submissions across FDA, EMA, ANVISA, Health Canada, and beyond
- IND-to-BLA planning – practical approaches to streamline submissions and reduce risk
- Emerging modalities – navigating evolving guidance for next-generation CGTs
With regulators, leading biotech innovators, and experienced regulatory strategists all in attendance, this event offers the only comprehensive look at the regulatory expectations shaping 2025 and beyond.
Whether your focus is early-stage IND preparation, late-stage BLA strategy, or post-market compliance, this summit equips you with the knowledge, frameworks, and peer connections to stay ahead of evolving requirements.
👉 Learn more and secure your place here: https://ter.li/qxpkae
