Full-day Virtual Seminar - South Korea: Navigating the Regulatory and Clinical Trial Environment (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: Dec 09, 2011||End Date/Time: Dec 09, 2011|
This 6-hr training will provide valuable insights into how regulations and compliance issues are culturally handled in Japan.
This course specifically focuses on the regulatory compliance requirements and procedures for conducting Clinical Trials on Pharmaceutical Products in Japan. The course will also cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in South Korea. Content will also include descriptions of the methods by which regulators in the Ministry of Health / KFDA process filings and registrations for new Clinical Studies and what is expected throughout the lifecycle of Phase I â€“ Phase IV studies in the country.