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  • Hi everyone I have some questions regarding EU's GDPR.  1. First, what are the main differences between GDPR and HIPAA?  Has anyone done a gap analysis between GDPR and HIPAA? 2. How does privacy protection interact with the MDR?  Does it form part of the risk analysis file?  Thanks. ------------------------------ Karen Zhou ------------------ ...

  • To address the Coronavirus outbreak, China's health system recently eased approval rules to allow for critically needed devices and diagnostics.  On January 27, the NMPA authorized the import of non-NMPA approved medical devices that meet certain requirements including FDA, CE Marking or Japan approval. China continues to face a gap in diagnostics ...

  • There is a very good position paper from the EFPIA from January 2020 on the use of Form 1572 outside the US and the exact problem you face.  Just search on EFPIA and 1572 form and you should find it.  I have also attached it for reference.  This pretty much mimics what FDA has said at meetings, etc. ------------------------------ Michael Hamrell, Ph.D., ...

  • Yep exactly Richard - thus why we - and me personally - have removed the word "checklist" from my vocabulary, documents, procedures, templates, etc. because there is much more involved with GSPR now.  I would even argue calling it the GSPR Trace/Traceability Matrix because most likely how it is going to be used now. ------------------------------ Richard ...

  • Great to know. Thank you for sharing. Is the final regulation or amendment now published? Much appreciated, April ------------------------------ April Komplin Sun Prairie WI United States ------------------------------


Volunteer Appreciation 2019

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here

 

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