On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation").
Especially the procedure for assessment and approval of multinational clinical trial authorisation applications will change. A single authorisation procedure for clinical trials will be introduced that will be performed electronically via a new EU portal.
The Regulation will ensure that, no matter where a clinical trial is being performed, the fundamental rules for the protection of subjects are applied. It therefore includes rules for clinical trials which are conducted outside the EU but referred to in a clinical trial application within the EU. For such trials, the rules call for compliance with regulatory requirements at least equivalent to those in the EU, including rules on transparency
Why Should You Attend
It is important to know the new procedures for approval of clinical trials to avoid delays and minimize the time for approval.
In the current situation, a common protocol is proposed in all EU Member States that participate in a clinical trial but requests for amendments may result in country-specific changes that require subsequent amendments in other countries to maintain a common protocol.
In the Webinar it will be explained how in the new procedure this problem will be avoided.
The Webinar will also discuss important changes with regard to the protection of subjects and give a detailed overview of the new procedure. A detailed knowledge of the new procedure are all key to personal responsible for clinical trial applications.
Additionally, the new Regulation will affect how the conduct of a clinical trial is managed after approval has been granted. New provisions for public access to an EU clinical trials database will enforce disclosure of clinical trials data and information.
The new Regulation will change the way pharmaceutical companies handle the clinical trial approval process, and companies need to start preparing for these changes now. The timelines for implementation will be discussed in this Webinar to allow optimal preparation.
Areas Covered in this Webinar
The webinar will start with a discussion of the disadvantages of the current situation.
An overview of the Clinical Trials Regulation and the scope of the regulation will be provided. In particular the following points will be addressed:
The timelines for implementation will be described.
Who Will Benefit
Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004, he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003, he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked for four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996, he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands.View all trainings by this speaker