Regulatory Affairs Community

Hello Beth, In the US, the only formal guidance from FDA that describe any areas of enforcement discretion around proactive dissemination of information ...

Is there a good resource for guidance on proactive dissemination of medical information before product approval? Things like reprints in a medical booth, ...

For our meeting next Wednesday, 19-March at 11am ET, we have experts from Docuvera coming into showcase an example of component-based authoring and generative ...

Thanks all for the amazing turnout today! wowzer. We sure appreciate your support of the WG. We had a great meeting today covered the following topics: ...

Hi all, On March 11, 2025, EMA released its latest CTIS Newsflash, providing significant updates on CTIS and links to useful reference materials. The ...

The development of an Artificial Intelligence (AI) Action Plan is underway, and YOUR input is needed! 📢 This action plan is a required output of ...

Hello All - You don't want to miss the next AdPromo WG on Tuesday, March 11 @ 12 PM ET (see Zoom info below). Join us for a deep dive into the 1st OPDP ...

Hi all, The New Information Platform HumRes (Human Research Switzerland), formerly 'Portal for Human Research in Switzerland', became live on 01 March ...

Hi all, The European Medicines Agency (EMA) has published the latest revisions in several CTIS training program documents that enhance public access ...

Join us in Arlington, VA on April 7-8 for DIA's Global Labeling Conference . Register by end of day Monday, March 10 and save $300! Here's why you ...

Hi all, On February 28, 2025, the homepage of the Australia and New Zealand Clinical Trials Registry (ANZCTR) website hosted by the University of ...

Hold the Date for the next AdPromo WG on Tuesday, March 11 @ 12 PM ET (see Zoom info below). Join us for an insightful discussion with our Guest Presenter ...

Dear all, The UK Health Research Authority (HRA) provided an update on February 28 th on the progress of the new Clinical Trials Regulations. The ...

Hi all, On February 25, 2025, EMA released its latest CTIS Newsflash, providing significant updates on CTIS and links to useful reference materials. ...

Hi all, The Accelerating Clinical Trials in the European Union (ACT EU) initiative supports clinical trials through regulatory, technological and process ...