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.

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

Session Chair(s)

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)

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

Massimiliano Sarra, PhD, MPH

Permanent official and CTFG Secretary, Italian Medicine Agency (AIFA), Italy

Anca Budulac

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

Patients vs Clinical Trials

Costin Radu Ganescu

Vice President, European Patients Forum (EPF), Romania

Laurentiu Micu

Senior specialist internal medicine, Fundeni Clinical Institute, Romania

Austria

Stefan Strasser, MD

Head of Clinical Trials, Institute Surveillance, AGES, Austria

Bulgaria

Bovan Dognev

Vice-President, Bulgarian Central EC, Bulgaria

Slovakia

Katarina Kovacova

Clinical Trial Expert for Ministry of Health, Institute for Research & Development, BioHub, Slovakia

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Clinical Trial Regulation Information Day for CEE Countries

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

Session Chair(s)

Massimiliano Sarra, PhD, MPH

Speaker(s)

Be informed and stay engaged.