This is the recording of the press briefing of European Medicines Agency from 25 January 2022 on entry into force of the Clinical Trials Regulation and the launch of Clinical Trials Information System scheduled to take place on 31 January 2022.
00:00 Introduction
02:01 Update from Andrzej Ryś, Director, European Commission
07:34 Update from Karl Broich, Heads of Medicines Agencies (HMA)
13:47 Update from Emer Cooke, Executive Director, EMA
20:35 Questions from the journalists
21:19 Challenges in the implementation of new Clinical Trials Regulation
27:21 Lessons learnt from clinicaltrials.gov and what are workspaces in CTIS?
29:45 Wrap up
30:50 Attractiveness of Europe as a place to do clinical research
Speakers:
Andrzej Ryś, Director of Health Systems, Medical Products and Innovation Directorate, European Commission
Karl Broich, Heads of Medicines Agencies (HMA) Management Group Chairperson and President of BfArM
Emer Cooke, Executive Director, EMA
Fergus Sweeney, Head of Clinical Studies and Manufacturing Task Force, EMA
EMA Moderator:
Marie-Agnes Heine, Head of Communication
#EMAPresser #COVID19
CTR / CTIS go-live press briefing 25 January 2022
Теги
emaEMAPresserpressbriefingjournalistsicknesstreatmentfragileregulatormarketing authorisationdataevidenceeffectivenessevolutionclinical trialsCTISCTRonlineportalwebsitesponsorsEuropean CommissionDG SANTEHMAHeads of Medicines Agencieshubresearchclinicaltrialsattractiveness of Europeclinical researchnumber of clinical trials in EUUSAclinicaltrials.govlessons learntmulti-nationalClinical Trials Information Systemacademiaemer cooke