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Virtual Event

Sep 18, 2020 8:30 AM - Sep 18, 2020 5:30 PM

(Central Europe Standard Time)

4051 Basel, Switzerland

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)? Join the discussion on managing clinical trials in the face of changes coming soon in 2021.

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

Session Chair(s)

Stefan  Strasser, MD

Stefan Strasser, MD

Head of Clinical Trials, Institute Surveillance

AGES, Austria

Session 4: 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

Piotr S. Iwanowski, MD, PhD

Panel Discussion Focusing on Challenges and Solutions. Panelist from Poland:

Piotr S. Iwanowski, MD, PhD

Assoc. Vice President Clinical Research Europe, Wockhardt Bio AG, Poland

Board Member, Polish Association for Good Clinical Practice (GCPpl)

Ewa  Oldak, PhD

Panelist from Poland:

Ewa Oldak, PhD

The Office for Medicinal Product, Medical Devices and Biocidal Products , Poland

Director, Department for Clinical Trial of Medicinal Products

Stefan  Strasser, MD

Panelist from Austria:

Stefan Strasser, MD

AGES, Austria

Head of Clinical Trials, Institute Surveillance

Katarina  Kovacova

Panelist from Slovakia:

Katarina Kovacova

Institute for Research & Development, BioHub, Slovakia

Clinical Trial Expert for Ministry of Health

Eunika  Ksiazkiewicz

Panelist from Poland:

Eunika Ksiazkiewicz

Medical Research Agency, Poland

Legal Specialist for Scientific Projects

Mirela  Vita, MD

Panelist from Romania:

Mirela Vita, MD

NAMMDR, Romania

Physicain Clincial Trails Assessor

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