25th Aug, 2016 - 10h (CET) - EU Clinical Trials Regulation (EU) No 536/214

Webinar Topic 

EU Clinical Trials Regulation (EU) No 536/214 – Submission and Authorisation Process


Webinar Date & Time

25 August 2016 from 10:00 to 11:30 (CET)


Webinar Overview

European Legislation for Clinical Trials

EU has come forward with legislation for clinical trials in the form of a Directive in 2001 (Dir. 2001/20 EC) that had to be transposed into national law by the Member States in 2004. More than a decade has passed since then and all stakeholders gained vast experience with the European system. Although many positive elements can be recognised in the current legislation, overall, the Directive did not fulfil the expectations. Member States used their right to “add on” to the core legislation that was set out in the Directive. As a consequence, national particularities worked against harmonisation. In multi-national clinical trials, the requirement to submit in every Member State adds to the administrative burden and is perceived as duplication of work. The goal to make the EU an attractive place for clinical research seems to be jeopardised. The fact that the number of clinical trials in the EU has declined by about 25% over the last 5-8 years, might be – among other reasons - also based on the current landscape for clinical trials in the EU.

The new regulatory approach: a new EU “Regulation” on clinical trials ((EU) No 536/2014) is in force since 16 June 2014 and will repeal Directive 2001/20/EC as soon as the Regulation is coming into effect. Latest publication by the EMA states that the new Regulation will apply in October 2018.

Stakeholders will face a number of changes, be it pertaining to definitions, the scope of the Regulation or the submission and authorisation process. Other procedures like informed consent, safety reporting and labelling of IMPs are affected as well by the new Regulation. Last but not least, new rules for transparency will change the environment for clinical trials drastically.

This webinar is the 2nd of a series of webinars on the EU Clinical Trials Regulation (EU) No 536/2014. After the first webinar on definitions and scope of the Regulation, this webinar will cover the future submission and authorisation process of clinical trials in the EU. Safety procedures and informed consent procedures will be upcoming topics.



Clinical Trial Submission and Authorisation Process

  • Initial Application
  • Substantial Modifications
  • Subsequent Addition of a Member State Concerned

Application Dossier



Dr. Dagmar Chase, Vice-President EUCROF

Managing Director Clinrex GmbH


Attendance Fee

€ 90,- for EUCROF non-members

€ 60,- for EUCROF members only.


Deadline for registration

24 August 2016


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