Dr. Frank Li, Founder & Principal Consultant of BLA Regulatory, will be a featured speaker at an upcoming online seminar hosted by Japan R&D Support Center, sharing insights on successful U.S. drug development and the latest FDA regulatory landscape.
Webinar Information:
📅 Date: Thursday, August 27, 2026, starting at 8:00 PM (EDT)
💻 Format: Online
🏢 Organizer: Japan R&D Support Center
📄 Flyer: Download the Webinar Flyer [EN] [JP] [KR] [CN]
Navigate the U.S. Drug Development Pathway with Confidence
For biotech and pharmaceutical companies outside the United States, entering the U.S. market presents significant opportunities—but also complex regulatory challenges.
How should you prepare for an IND? When should you engage with the FDA? What regulatory strategy can help reduce development risks and avoid unnecessary delays?
In this online seminar hosted by Japan R&D Support Center, Frank Li, MD, PhD, RAC, Founder & Principal Consultant of BLA Regulatory, will join fellow industry experts to share practical insights into U.S. drug development, FDA regulatory strategies, and the latest regulatory developments.
The seminar is designed for pharmaceutical and biotech companies seeking to advance their drug development programs in the United States.
What You Will Learn
During this seminar, attendees will gain insights into:
- Strategies for successful drug development in the U.S.
- Latest FDA regulatory expectations and updates
- Regulatory strategies from early development through marketing approval
- IND, NDA, and BLA submission planning
- FDA meeting preparation and regulatory communication
- Practical approaches to common regulatory challenges
Ready to strengthen your U.S. regulatory strategy?
Gain practical insights into navigating FDA requirements and advancing your drug development program in the United States.