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ICH webinar to update on M11 clinical trial guideline

ICH webinar to update on M11 clinical trial guideline

A free webinar on the M11 Guideline has been organised by the International Council for Harmonisation (ICH) M11 Expert Working Group (EWG). The Guideline is an initiative to promote greater harmonisation across international clinical trial protocols. The webinar takes place on 26 January 2023 at 10am-12pm EST (3-5pm GMT).

17 Jan 2023
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EMA reminder that clinical trials must use CTIS

EMA reminder that clinical trials must use CTIS

The European Medicines Agency (EMA) has issued a reminder that from 31 January 2023 clinical trial sponsors must use the Clinical Trials Information System (CTIS) for initial trial applications.

9 Jan 2023
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EMA and ECDC collaborate on vaccine safety and effectiveness monitoring studies

EMA and ECDC collaborate on vaccine safety and effectiveness monitoring studies

The European Medicines Agency (EMA) and European Centre for Disease Prevention and Control (ECDC) held the first meeting of the Immunisation and Vaccine Monitoring Advisory Board (IVMAB) of the Vaccine Monitoring Platform (VMP) in early December. Via the VMP they will coordinate and oversee EU-funded, independent post-authorisation studies on vaccines use, safety and effectiveness in EU countries.

30 Dec 2022
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