Large Language Models (LLMs), including ChatGPT and Bard, offer great potential to mimic human conversation. LLMs only directed toward general purposes and whose developers make…
The ECA has published a new guide to illustrate the generally applicable requirements for the design of GMP equipment and to explain how the connection…
Products classified as medical devices must demonstrate they meet the requirements of UK Medical Devices Regulations. The purpose of these regulations is to ensure the…
The MHRA has published its GCP Inspections Metrics Report covering the period 1st April 2019 to 31st March 2020. Perhaps of interest to HSRAA members are…
This guideline (which replaces EMA/INS/GCP/454280/2010 Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials) describes some…
Welcome to WordPress. This is your first post. Edit or delete it, then start writing!
Each year the HSRAA is invited to represent the views of archivists at the MHRA GLP StEM (Stakeholder Engagement Meetings). The 2022 StEM will take…
Raw data in electronic structured format is currently not systematically included as part of marketing authorisation and variation applications submitted to EMA. However, the Regulations…
The latest edition of the EMA Clinical Trials Information System (CTIS) Newsletter provides insights on clinical trials topics. Of particular interest to HSRAA members is…
The EMA Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–25. For more…