Medical Writing Community

Hi all MRCT is organising a webinar on Tuesday, June 4, from 11 – 12 PM ET to explore the practical uses and applications of the MRCT Center's Clinical ...

Hi all The EMA is currently running a pilot programme offering scientific advice for high-risk (Class IIb and Class III) medical devices. EU-based manufacturers ...

Hi all PHUSE's EU CTR Implementation project within the Data Transparency Working Group has posted a Year 2 update blog on EU CTR Implementation ...

Hi all EMA published " Guidance on real-world evidence provided by EMA: support for regulatory decision-making " that describes how real-world evidence ...

Hi all DARWIN EU® (Data Analysis and Real-World Interrogation Network) generates real-world evidence (RWE) to support EMA committees and national regulators ...

Hi all Following the UK's exit from the EU, MHRA became a full Member of ICH in May 2022. A page directory for current ICH Guidelines implemented ...

Hi all Nguyen et al.'s review article " Regulatory Issues of Platform Trials: Learnings from EU-PEARL " provides the most up-to-date assessment ...

Hi all The FDA has opened for comments the revised guidance document Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission ...

Hi all European medical Writing Association (EMWA) is organising a webinar next week that will focus on Securing Medical Writing: Navigating ...

Global Clinical Trial Disclosure and Data Transparency Conference September 23-24, 2024 | Westin Arlington Learn about the latest requirements ...

Do you have an idea that would make a great presentation, session or short course at the DIA Latin America Annual Meeting? If so, submit your abstract ...

Hi all The EU Medical Device Coordination Group released the MDCG 2024-3 Guidance on content of the Clinical Investigation Plan (CIP) for clinical ...

Hi All – Discussions for today's meeting 1 – Deadline for submission for Japan DIA Annual. I think that we may need two sessions: our CDM review and ...

Just a quick reminder to join our MW Community SHARED LEARNING SESSION! Date: Wednesday, 13 March 2024 ...

Have your voice heard! The Call for Abstracts is now open for the Latin America Annual Meeting until Sunday, March 31. We are seeking abstract ...