Speaker Profile


Adriaan Fruijtier

Regulatory Affairs Consultant, CATS Consultants GmbH

Adriaan Fruijtierhas 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 during 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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The New Clinical Trial Regulation

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").

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Regulatory Aspects of Advanced Therapy Medicinal Products in the EU

Advanced therapy medicinal products are human cells and tissues or products with a genetic mode of action; they generate huge expectations but are also associated to new significant threats including tumorigenicity, cell (de)differentiation, and patient integration.

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Scientific Advice in the EU

Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorization application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorization. Following advice from the Regulatory Authorities increases the probability of a positive outcome.

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Product Information in the EU

In order to obtain a marketing authorization, a Summary of Product Characteristics (SmPC) in accordance with Article 11 of Directive 2001/83/EC must be included in the application. In accordance with Directive 2001/83/EC, when the marketing authorization is issued, the Marketing Authorization Holder shall be informed, by the competent authorities of the Member States concerned, of the SmPC as approved by it. For decisions concerning centralized marketing authorizations, according to Article 10 of Regulation (EC) No 726/2004, the final Commission decision with the SmPC is addressed and notified to the Marketing Authorization Holder.

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