The New Clinical Trial Regulation

    /Adriaan  /Fruijtierspeaker of compliance global
    Speaker: Adriaan Fruijtier
    Duration: 60 Minutes
    Product Code: 700185
    Level: Intermediate
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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.

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Areas Covered

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: 

  • A streamlined application procedure via a single entry point;
  • An EU portal and database, for all clinical trials conducted in Europe. Registration via the portal will be a prerequisite for the assessment of any application;
  • A single authorisation procedure for all clinical trials, allowing a faster and thorough assessment of an application by all Member States concerned, and ensuring one single assessment outcome and authorisation per Member State. Ethics committees will be involved in the assessment of clinical trials application. However, as with the current situation, their responsibilities and detailed composition will be determined independently by each EU country. In this way the different traditions in the various Member States are respected
  • The extension of the tacit agreement principle to the whole authorisation process which will give sponsors and researchers, in particular SMEs and academics, more legal certainty. The tacit agreement is to alleviate an unnecessary and frustrating restriction that trial sponsors face under the current rules. It is important, however, to emphasise that Member States will always have the possibility to stop any clinical trial, which they consider could endanger the heath of the participants
  • Strengthened transparency for clinical trials data. Transparency on the conduct and results of clinical trials has several benefits, and the Regulation strengthens the rules accordingly Transparency avoids redundancy and duplication. It ensures that even clinical trials with unfavourable results are made public, thereby avoiding 'publication bias'. Finally, transparency gives patients the possibility to find out about on-going clinical trials in which they may wish to participate
  • The concept of a 'low-intervention clinical trial' – an example being clinical trial phases comparing already authorised medicines. In such cases, the regulatory requirements will be lighter 

The timelines for implementation will be described.

Learning Objectives

  • Knowledge of the new Regulation
  • Knowledge of the impact of the new Regulation for the industry


  • Regulatory Affairs Personnel
  • CRA’s 
  • Clinical Operations Personnel
  • Personnel in the pharmaceutical and biotech industries who need a thorough understanding of the regulatory issues involved in the development of new medicinal products within the European Union
  • Individuals who are seeking to update their knowledge of recent regulatory changes and their impact on product development


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.

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