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    MHRA update for GCP

    MHRA updated their Good Clinical Trials guideline on 22 May 2020. https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials ------------------------------ Terry Katz Chair, DIA GCP-QA Community ------------------------------

  • Today, Wednesday 27 May, at 10a,  Ioannis Chatziioannidis presents on Auditing and Audit Trails in Clinical Studies. 10a ET (16:00 CET)  Zoom Meeting:  https://diaglobal.zoom.us/j/97299875474?pwd=S0hWbHFIcm9zcTJ5clZaczQrVEU3Zz09  Meeting ID: ...

  • ​See April 16, 2020 updated Appendix questions at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic ​ ------------------------------ Jean Mulinde Policy ...

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  • Hi GCP-QA Community, With all the posts about COVID-19 challenges on clinical trials, I did not initially see this new EMA Notice to sponsors on validation and qualification of computerised systems used in clinical trials.  The two paragraphs state their ...

  • EMA created a task force to address COVID-19 medicines per their objective " to manage and coordinate the discussions on development, authorisation and surveillance of relevant medicinal products, which are under the remit of EMA, and post-authorisation ...

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    FDA/CVM

    Issued this morning.  FDA's Center for Veterinary Medicine states: Many of the challenges noted in FDA's Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic , issued in March 2020, may arise during the conduct of studies ...

  • Last Friday, the GCP-QA Core Community held an internal discussion on practical steps Sponsors and CROs could take to adjust to the changing landscape of clinical trials under the COVID-19 pandemic.  These GCP items are aligned with the newest FDA, EMA, ...

  • FDA updated last week's Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, adding a Question and Answer appendix. https://www.fda.gov/media/136238/download ------------------------------ Terry Katz Chair, DIA GCP-QA ...

  • GCP-QA, we have seen FDA and MHRA guidelines for clinical trials during the coronavirus pandemic, and included here is the link to the EMA guideline that specifically address GCP issues.  The new guideline states: Extraordinary measures may need to ...

  • FDA has continued to publish new guidelines in effect during the coronavirus pandemic.  On March 20 they issued an Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public ...

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