ComplianceOnline, Hyatt Regency Columbus 350 North High Street
t 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
- Regulatory personnel whose responsibilities require knowledge of Japan's and South Korea’s Regulatory and Clinical Trial environment
- Global Supply Chain personnel
- Manufacturing personnel
||Robert J. Russell
President of RJR Consulting, Inc
Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.