Obtain Regulatory Approval for Gene Therapy
& Gene Editing Therapeutics
Welcome to the Gene Therapy Regulatory Affairs Summit
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 unites 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 on this unrivalled opportunity to inform your trial design, perfect your CMC approach and supercharge your global submission strategy for regulatory success.
Join 80+ industry leaders from 4D Molecular Therapeutics, Advanced Cell & Gene Therapy, Adverum Biotechnologies, Astrazeneca, Bridge Bio, Health Canada, Omega Therapeutics, Opus Genetics, Regeneron Pharmaceuticals, Sangamo Therapeutics, Solid Biosciences, Spark Therapeutics, Ultragenyx Pharmaceutical, and more…
EXPERT SPEAKERS FROM INDUSTRY LEADING COMPANIES
HOURS OF NETWORKING OPPORTUNITIES
DAYS OF CAREFULLY
CURATED CONTENT
PRE-CONFERENCE
WORKSHOP DAY
Download the Full Event Guide for more information on:
- 17+ Expert Speaker Faculty
- Full access to the 3-day conference agenda
- Pre-conference workshop day details
- Audience Breakdown
- & more
World-Class Speaker Faculty Includes:
Exclusive Interviews From the Likes of:
Yao-Yao Zhu
Ex-FDA & Director of Global Regulatory Affairs
AstraZeneca
Join your Gene Therapy Peers from the likes of:
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”
Other Events in the Gene Therapy Series
