31 SIERPNIA 2020 21:59
Autor: Karol Szczukiewicz

Clinical Trial Regulation Information Day – going virtual on 18 September

Due to the outbreak of the COVID-19 pandemic, DIA decided to change the format of the upcoming DIA Clinical Trial Regulation Information Day from "face-to-face" to entirely virtual.

This event will take place on Friday 18 September in an entirely interactive virtual meeting format that mirrors in-person events, with both speakers and attendees participating remotely, in real-time. Additional benefits are savings on travel costs, more time for Q&A and recorded sessions being available to all paid attendees.

Is your Organization Ready for Implementation of Clinical Trial Regulation (CTR) in 2021? If you still have any doubts around the topic join regulators and experts in the field join virtually on 18 September and hear about Member States preparedness for the regulation and plans for co-operation between agencies and ethics committees. The CTR will introduce significant changes to the administrative process and procedures which will add complexity during the transition from Directive to CTR phase.

Radosław Sierpiński, Acting President from the Polish Medical Research Agency (ABM) will open the event with a keynote, introducing the newly created Medical Research Agency which aims to bridge the gap between the Polish healthcare system and biomedical sciences to improve access to clinical trials.

A Member of the Clinical Trials Facilitation Group (CTFG) secretariat together with Stefan Strasser from The Austrian Agency for Health and Food Safety (AGES) will take you on a journey from the existing Directive 2001/20/EC to the CTR (EU Regulation 536/2014).

Fia Westerholm, Programme Assurance Manager of the Clinical Trials Information System (CTIS) programme, EMA, will present an overview and update on the current status of the Clinical Trial Information System (CTIS), providing an opportunity to ask questions about the CTIS functionalities.

Further, Representatives of regulatory authorities will discuss the current status of preparedness in their country.

Among confirm participants are:

  • Eunika Książkiewicz, Medical Research Agency, Poland

  • Katarina Kovacova, State Institute for Drug Control (SUKL), Slovakia

  • Violeta Getova and Veska Gergova, the Bulgarian Drug Agency (BDA), Bulgaria

  • Mirela Vita, National Agency for Medicines and Medical Devices of Romania (NAMMDR), Romania


Learn more

Details of this Information Day

Date: Friday, 18 September 2020

Location: virtual

Registration Information

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

Register now