Obtain Regulatory Approval for Gene Therapy
& Gene Editing Therapeutics
This Event Has Now Run
Welcome to the Gene Therapy Regulatory Affairs Summit 2024
Overcome Regulatory Hurdles Across Non-Clinical, Clinical & CMC Functions from Pre-IND Through to Approval and Satisfy Regulatory Requirements for Gene Therapies by Demonstrating Safety & Efficacy
With 2023 welcoming newly FDA-approved gene therapies from BioMarin, Krystal Biotech and Sarepta Therapeutics, many more treatments are hot on their heels for approval, investment is pouring into developing gene therapies and the role of regulatory affairs has never been more important.
As the first ever regulatory affairs forum wholly dedicated to gene therapy, this meeting uniquely united regulatory bodies and the leading regulatory personnel across big pharma and innovative biotech to discuss the hottest topics, identify industry bottlenecks and offer actionable insights.
Don’t miss out in 2025 on this unrivalled opportunity to inform your trial design, perfect your CMC approach and supercharge your global submission strategy for regulatory success.
It would be your chance to join 80+ industry leaders from 4D Molecular Therapeutics, Advanced Cell & Gene Therapy, AstraZeneca, Bridge Bio, Health Canada, Omega Therapeutics, Opus Genetics, Regeneron Pharmaceuticals, Sangamo Therapeutics, Solid Biosciences, Spark Therapeutics, Ultragenyx Pharmaceutical, and more…
2024 Agenda Highlights Included...
EXPERT SPEAKERS FROM INDUSTRY LEADING COMPANIES
HOURS OF NETWORKING OPPORTUNITIES
DAYS OF CAREFULLY
Our 2024 World-Class Speaker Faculty Included:
Regulatory Affairs CMC Lead
Senior Director of IVD Regulatory Affairs
Senior Director of Regulatory Affairs
Vice President, Regulatory Affairs, Genetic Medicines
Regeneron Pharmaceuticals Inc
Who Attended in 2024?
Previous Gene Therapy Event Series Attendees Have Said:
“I think the diversity of discussions and presentations was extremely useful. Overall, an excellent conference and well organized.”
“Direct feedback from influential Health Authority staff, which added to the overall conference value”