• June 3-6, 2024
  • San Diego Convention Center, California

Sessions

Loading

Regional Approaches to Regulatory Approvals

Wednesday, June 05, 2024
Breakout Session
Emerging Opportunities in Global Markets
26B
The European Union’s transition to a regional approvals regime has created challenges, as well as opportunities, for industry’s global growth. Other regulators, such as PMDA in Japan, are trying to replicate this approach. Join us for an exciting session where our experts from Japan and the EU discuss their approaches to regulatory approvals in their region. We will share lessons learned on how companies can use these models to streamline their regulatory approval process.
Moderator
Nancy Travis
Vice President of International Affairs
BIO
Speakers
Steffen Thirstrup, MD, PhD
Chief Medical Officer
European Medicines Agency (EMA)
Yoshiaki Marumaya
Review Director at the Office of Cellular and Tissue-based Products
PMDA
Back to Session List

BIO DOUBLE HELIX SPONSORS

Thanks to our sponsors for supporting our mission to drive a revolution to cure patients, protect our climate, and nourish humanity.

Loading

BIO HELIX SPONSORS