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Intro
EMA Stakeholder Group
Framework for interaction between the EMA and healthcare professionals
How are healthcare professionals involved in the EMA?
Medicines regulatory pathway
Organizations that the EMA works with
The HCP Working Party
The members of the HCPWP
How to learn more about the HCP Working Party
Transparency initiatives of the EMA
Introduction
Update on recent developments (as of 04.11.2021) by Dr. Cavaleri
Questions from journalists
What are the tools to tackle the pandemic
Fourth dose of COVID-19 vaccine
Mix and match approach
Antiviral therapies
Data on AstraZeneca
Children vaccination
BMJ report
Monoclonal antibodies
Pregnant women
Vaxveria vaccine
Molnupiravir and Fluvoxamine
Wrap-up
Topics covered in this lecture
Evolution of European clinical trials legislation
Three pillars of the Clinical Trials Regulation
Clinical Trials Regulation - what's in scope?
CTA dossier content and assessment timelines
The Clinical Trials Regulation foresees a 3-year transition period to CTIS
CTIS - Clinical trials information system
CT Regulation: Publication of data
Fields/ documents that will not be published
Accelerating Clinical Trials in the EU (ACT EU)