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  • As COVID eventually stabilizes, many Sponsors, CROs, Academic Institutions, and Regulatory Agencies, can reflect on the great progress made in the use of telemedicine, remote monitoring/SDV, drug shipping to local clinics or homes for administration, ...

  • Dear Colleagues, Following the presentation on Remote Inspections in July 2020, MHRA recently announced that they will start onsite inspections from September 2020.  https://mhrainspectorate.blog.gov.uk/2020/07/23/mhra-planning-for-return-to-on-site-good-practice-gxp-inspections/ ...

  • Dear Kamila, Thank you for the information. Best regards, Dipika ------------------------------ Dipika Shringarpure ------------------------------

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    RE: Post-COVID GCP

    Thank you Yvonne for reaching out.  We must definitely would like to hear your experiences!  Academic Site Networks, Sponsors, CROs, Research Laboratories, IRBs/EC, Government Agencies, all have valuable input into dealing with the current situation and ...

  • Reminder: Next week is the USA Annual DIA Meeting.  For those Community members registered to attend, our sessions are: Tuesday 16 June, 3:15p ET, Session 241 content hub: A Risk-Based Approach to Implement Audit Trail Review and Inspection Readiness ...

  • Next week starts the DIA Annual Meeting.  Presentations from our GCP-QA Community include: Tuesday 16 June, 3:15p ET, Session 241 content hub: A Risk-Based Approach to Implement Audit Trail Review and Inspection Readiness Plans in a Data Integrity Conscious ...

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    ICH E6(r3)

    For the past 2 days, CTTI & FDA sponsored a webinar on proposed areas for update with ICH E6(r3).   R(3) will add 2 annexes Annex 1 - Interventional clinical trials: use of unapproved or approved drugs in a controlled setting with prospective allocation ...

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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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