Saerom Shin is an Assistant Advisor in the Regulatory Practice and
Analysis Branch at Medsafe, Ministry of Health. Before joining Medsafe, Saerom
worked in the medical devices industry
as a regulatory and quality assurance specialist in Seoul, South Korea. She has
6 years of experience in crafting conformity assessment dossiers for product
approval as well as assisting GMP audits for overseas manufacturing sites.
Therapeutic Products Regulation Workshop
The Ministry of Health's work on the development of the new
regulatory scheme for therapeutic products is progressing steadily. This
session will provide an opportunity to be updated on progress and to discuss
the overall approach proposed for the regulation of medical devices.