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Learn China Mandatory Period Risk Evaluation Report (PRER) and the latest PMS Requirements in China NMPA and US FDA
July 9, 2020 @ 12:00 pm – 1:10 pm
China has been increasing its surveillance on post market monitoring with more regulations and random inspections both inside China and outside of China. Find out how to meet the upcoming deadline for the new Period Risk Evaluation Report (PRER) regulations now required by National Medical Products Administration (NMPA) for all Class II and Class III devices in their 1st approval cycle. Do not miss the PRER submission deadline of September 30, 2020. In these webinar, we will give you a brief idea about:
- What is the latest requirements/regulations for PMS/QMS in China NMPA and US FDA
- How to complete and meet the China NMPA PRER submission deadline of September 30 2020
- Familiarize yourself with how to leverage your overseas QMS for your China operations by understanding China GMP regulations and Chinese culture differences
- Find out how to comply with required adverse events (AE) and serious adverse events (SAE) reports in FDA and NMPA
- Case Studies about mock audit, AE/SAE reporting, etc.