Anon, This is a "must do" exercise medical device manufacturers need to go through and there can be many different ways to do this. It can be from having a couple check boxes on a component specification, read more
Good day Anon, Without seeing the exact shipping path and transactions occurring - based on the information provided, yes this is ok. In fact, shipping products within the European Union is quite ok read more
Anon, There is not really any guidance out there - I gave a presentation concerning this at RAPS Euro Convergence in 2023 so might be able to find some "white paper" information. I would not have a template read more
Hello Folks, I have 21 years work experience in QA&RA function, and 14 years work experience in MNC medical company as a QA/RA Supervisor/ Manager/MR. The headquarters are located in EUROPE / USA. My read more
China NMPA also creates the searchable database open to public: ๅฝๅฎถ่ฏๅ็็ฃ็ฎก็ๅฑๅป็ๅจๆขฐๅฏไธๆ ่ฏๆฐๆฎๅบ (nmpa.gov.cn) ------------------------------ Minghua Chen BD Manager, APAC Qserve Group (China) Nanjing China --- read more
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Yemi Ijose Regulatory Affairs Senior Manager GC America Inc. ...
Hi Everyone Just a reminder we will meet this week at 3 pm to 4 pm on Friday. I will present Chapter 8 of EU, from the 5th edition of the RAPS Study Guide. Join Zoom Meeting https://umaryland.zoom.us/j/96213811970?pwd=V2lQeWowQTAxaDc2U2lpU0h3dVZ4dz09 ...
This message was posted by a user wishing to remain anonymous Hello, I am working on updating Module 3 sections for an IND as we are beginning Phase 3. This is a clinical-stage biotech and this is the DS and DP that will be used in registrational ...
This message was posted by a user wishing to remain anonymous We plan to send out a Dear Dr Letter to notify investigators of a new safety event for our investigational drug. Do we need to submit this Dear Dr. Letter to FDA for review first before sending ...
You are making a presentation to the senior management team. You announce that there is no way that the FDA will clear your device in less than 120 days. The head of marketing says, "In my last company, the regulatory affairs group was able to get a ...
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