Overview of the NDA/BLA Process in South Korea
The webinar was successfully concluded on
November 29, 2023
Topics Covered:
- Introduction
- Types of Business Licenses for Drug Products in Korea
- Dossier Preparation
- MFDS Review Process
- Health Authority Meeting
- GMP Site Inspection
- Approval
- DMF Registration
- Orphan Drug Designation
- Question & Answers
As a continuous practice, Freyr will continue to organize more webinar sessions related to Regulatory aspects in Life Sciences. We presume you would like to be a part of all those sessions. If yes, we will be happy to inform you in prior about the next session.
Michael has forty (40) years of industry experience, with twenty-nine (29) years in CMC Regulatory functions and an additional eleven (11) years in other scientific development roles. His experience includes collaborating with Regulatory partner companies.
In Pyo Hong is a Regulatory Expert with over twenty-five (25) years of experience in the Korean pharmaceutical industry. He specializes in Regulatory affairs for pharmaceutical and healthcare products.
Hosted By
Michael Lambell
Sr. Vice President, MPR Regulatory Affairs
Presented By
In Pyo Hong
Associate Director, MPR Regulatory Affairs – South Korea