Novotel Bucharest City Centre

Oct 22, 2019 8:00 AM - Oct 22, 2019 7:00 PM

Calea Victoriei 37B Sector 1, Bucharest, Romania, 010061

Clinical Trial Regulation Information Day for CEE Countries

Are Central and Eastern European Union member states ready to implement the new EU Clinical Trial Regulation (536/2014)? This information day provides a platform for discussion about the status of the implementation and further compliance with the new Regulation, as well as the associated legislation in the region.

Session 4: Implementation and Readiness Status at the Local Level Member States and Ethic Committees

Session Chair(s)

Massimiliano  Sarra, PhD, MPH

Massimiliano Sarra, PhD, MPH

Permanent official and CTFG Secretary

Italian Medicine Agency (AIFA), Italy

Implementation and Readiness Status at the Local Level Member States and Ethic Committees

Speaker(s)

Massimiliano  Sarra, PhD, MPH

Status of Implementation in European Member States from CTFG Point of View

Massimiliano Sarra, PhD, MPH

Italian Medicine Agency (AIFA), Italy

Permanent official and CTFG Secretary

Anca   Budulac

Anca Budulac

), National Institute of Infectious Diseases-Prof. Dr. Matei Bals , Romania

Costin Radu  Ganescu

Patients vs Clinical Trials

Costin Radu Ganescu

European Patients Forum (EPF), Romania

Vice President

Laurentiu  Micu

Laurentiu Micu

Fundeni Clinical Institute, Romania

Senior specialist internal medicine

Stefan  Strasser, MD

Austria

Stefan Strasser, MD

AGES, Austria

Head of Clinical Trials, Institute Surveillance

Bovan  Dognev

Bulgaria

Bovan Dognev

Bulgarian Central EC, Bulgaria

Vice-President

Katarina  Kovacova

Slovakia

Katarina Kovacova

Institute for Research & Development, BioHub, Slovakia

Clinical Trial Expert for Ministry of Health

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