Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan and South Korea. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in both countries, the importance of partner selection and the cultural knowledge needed for success. The recent changes made by PMDA and KFDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agencies since these changes, will also be discussed.
Who will Benefit:-

This course will be beneficial to the following personnel whose responsibilities require knowledge of Japan and South Korea's regulatory requirements for Life Science products:

- Regulatory Compliance personnel
- Clinical / Pharma & Device personnel
- Clinical Trial Project Managers
- Monitors / CRAs
- QA / QC Personnel
- Pharmacovigilance reporting personnel