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11 MARCA 2020 12:31
Autor: Karol Szczukiewicz

UWAGA - wydarzenie zostało przesunięte na wrzesień 2020. Więcej informacji wktótce.

 

Is your organization ready for implementation of the New EU Clinical Trial Regulation (536/2014)? It will introduce substantial changes to the administrative process and procedures and adds complexity specifically during the transition phase. Join the discussion with regulators and experts in September 2020 in Warsaw and don’t miss these highlights:

Radosław Sierpiński, Acting President from the Polish Medical Research Agency (ABM) will introduce the Agency which was created last year and is aiming to bridge the gap between the Polish health care system and biomedical sciences and improve the access to clinical trials. The presentation will touch upon past, current and future activities of the Medical Research Agency in connection with the clinical trials.

Fia Westerholm from the European Medicines Agency (EMA) will provide an overview and update on the current status of the Clinical Trial Information System (CTIS) previously called “EU Portal and Database”

Massimiliano Sarra from AIFA & CTFG secretary and Stefan Strasser from AGES will cover the differences between the directive and the regulation, point out the challenges and take a deep look at the procedures for both initial authorization as well as substantial modifications.

In a panel discussion, key regulators from Poland, Czech Republic, Bulgaria, Romania and Slovakia will update on the current implementation status and how they are preparing for the change. Amongst the confirmed regulators for this panel are:

  • Jakub Berezowski & Eunika Książkiewicz from Medical Research Agency
  • Ewa Oldak from URPL
  • Lucie Kravackova from SUKL, CZ
  • Violeta Getova & Veska Gergova from BDA, Bulgaria
  • Mirela Vita from ANM, Romania
  • Katarina Kovacova external consultant for Ministry of Health, Slovakia

This conference provides the perfect neutral and professional platform for collaboratively discussing the principal guidelines for future development.

Learn more

Details of this Information Day

Date: TBC - September 2020

Location: Novotel Center, Marszałkowska 94, 00-510 Warsaw, Poland (TBC)

Registration Information

As a member of the GCP Association Poland, you profit from a 15% discount on the standard fee.

Register now


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