Update on the Evolving Global Gene Therapy Regulatory Policy Landscape

2:30 PM - 3:45 PM, Monday, June 3,2019 ・ 118A, Level 100
Scientific technology for gene therapy has made tremendous progress and the regulatory landscape is still developing. Both the FDA and EMA have issued recommendations for gene therapies. Panelists will discuss recent updates to the policy landscape for in vivo and ex vivo gene therapy as well as opportunities for harmonization.
Speakers
photo
Director, Office of Tissues and Advanced Therapies (OTAT), CBER
FDA
photo
Associate Director, Global Regulatory Affairs
Janssen
photo
Scientific Director, Advanced Therapies
Norwegian Medicines Agency (NOMA)
photo
Vice President Technical, Regulatory and Technical CMC Consulting Cell, Gene Therapy and Tissue Engineering
PAREXEL International
photo
EMA Liaison Official at FDA, International Affairs Division
European Medicines Agency