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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
    Steffen Thirstrup, MD, PhD Director, NDA Regulatory Advisory Board
    NDA Advisory Services Ltd, United Kingdom
  • Massimiliano  Sarra
    Massimiliano Sarra CTFG Secretary
    Italian Medicine Agency (AIFA), Italy
  • Mihaela  David
    Mihaela David Director Regulatory Affairs
    PSI CRO AG, Romania, Romania
  • Stefan  Strasser, MD
    Stefan Strasser, MD Head of Clinical Trials, Institute Surveillance
    AGES, Austria
  • Vladimir  Vujovic, MPharm
    Vladimir Vujovic, MPharm Regulatory and Safety Manager
    Optimapharm, Serbia
  • Vojtech  Kvita
    Vojtech Kvita Pharmacovigilance Specialist
    PrimeVigilance s.r.o., Czech Republic
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