Overview

This Clinical Trial Regulation Information Day provides a forum to prepare stakeholders from Central and Eastern European Countries for the implementation and launch of the new EU Clinical Trial Regulation (536/2014) which will replace the European Clinical Trials Directive (2001/20/EC). The Information Day will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes. It further aims to provide a platform for discussion about the compliance with the new Regulation and associated implementing acts in the region. You will hear from experts in the field and regulators from various Member States about their preparedness status for the new legislation and how the new rules will impact clinical trials run in the EU.

Featured topics

Clinical Trials Regulation objectives and why the replacement of EU Directive is needed
Clinical Trial Regulation Overview and Latest Status
Key changes from Directive to Regulation and associated challenges
Procedure for Initial Authorization and Substantial Modifications Mono and Multinational CTs
Submission of application dossier

Part I common scientific documents
Part II the national documents

New Process for Clinical Trial Registration and EU CT number application
Transition from the Directive to the Regulation
Implementation and readiness status at the local level in Central and Easter European countries
Competent authorities and Ethics Committees perspectives
Update on the CT Information System (CTIS) formally “EU Portal and Database”
Clinical Trials Regulation related guidelines

Who should attend?

This event is specifically targeted to colleagues in CEE countries:

Regulatory agencies: assessors, reviewers, inspectors
The pharmaceutical industry and contract research organisations, including:

Regulatory affairs personnel in clinical research
Professionals in charge of clinical trial strategy
Regulatory intelligence and policy professionals
Change managers for clinical trials business processes
Clinical research professionals working with submission, data, information sharing
Clinical safety professionals
Clinical Trials Investigators and Patients' associations representatives
Laboratory experts in clinical trials

Program Committee

Steffen Thirstrup, MD, PhD Chief Medical Officer
European Medicines Agency, Netherlands
Massimiliano Sarra, PhD, MPH Permanent official and CTFG Secretary
Italian Medicine Agency (AIFA), Italy
Mihaela David Director Regulatory Affairs
PSI Pharma Support Romania SRL, Romania
Stefan Strasser, MD Head of Clinical Trials, Institute Surveillance
AGES, Austria
Vladimir Vujovic, MPharm Director, Regulatory Affairs
IQVIA, Serbia
Vojtech Kvita Executve Director
NextPV Services, Czech Republic

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Clinical Trial Regulation Information Day for CEE Countries