New European regulation on clinical trials of drugs

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ANSM

Published on Apr 7, 2022
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The objective of this conference is a reminder of the key points of this regulatory system, the strategic issues and impacts of this new Regulation as well as the different vectors of exchanges existing with the actors of the field. This webinar will also be the occasion for an initial feedback a few weeks after its effective implementation. ▬▬▬▬▬▬▬▬▬▬▬ TO GO FURTHER ▬▬▬▬▬▬▬▬▬▬▬ ???? More information in our file: https://ansm.sante.fr/actualites/entr... ???? The video presentations: https://ansm.sante.fr/evenements/webi... ❓ A FAQ, updated regularly, is also available: https://ansm.sante.fr/documents/refer... ▬▬▬▬▬▬▬▬▬▬▬ AGENDA ▬▬▬▬▬▬▬▬▬▬▬▬ 00:00 Introduction by Caroline Semaille, Deputy Director General ANSM 00:03:23 Introduction by Gaëlle Guyader, Director of the Authorizations Directorate ANSM 00:05:02 New Clinical Trials regulation: a win/win lever in Europe and France for research and access to innovation (ANSM) 00:15:32 Notice to sponsors: points of attention on the main changes to the regulation (ANSM) 00:26:52 Notification of serious violations, inspection reports, unexpected events other than EIGI and MUS 00:35:06 Implementation in France of the new regulation of ECs of medicines - Focus on the organization of the ethical evaluation and ANSM-CPP coordination (Directorate General of Health) 00:53:55 Focus on the submission of dossiers via CTIS (Directorate General of Health) 01:12:17 Issues of the entry into force of the European drug regulation 2022 (National Commission for Research Involving Humans and representative of the CPP) 01:32:28 Point of view of a CPP 01:50:50 First assessment on CTIS (ANSM) 01:57:04 First steps on CTIS (ANSM) 02:03:46 Information on information channels and on European working groups (ANSM) 02:08:43 Conclusion and perspectives (ANSM)

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