Mastering EU Clinical Trials: Navigating the New Regulation and Its Impact on Trial Management
Online Masterclass
- 29th - 30th October 2024
- 9.00am – 1.30pm CEST (UTC+2)
Trainer
Adriaan Fruijtier
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Introduction
On January 31, 2022, the new Regulation (EU) No 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use came into force, revolutionizing the assessment and approval process for multinational clinical trial authorization applications. This regulation introduced a single authorization procedure for clinical trials, which must now be conducted electronically via a new EU portal. The regulation ensures that fundamental rules for the protection of subjects are uniformly applied, regardless of where a clinical trial is conducted. This includes clinical trials conducted outside the EU that are referenced in an EU clinical trial application. These trials must comply with regulatory requirements that are at least equivalent to those in the EU clinical trials regulation.
In this masterclass, Adriaan Fruijtier will provide a comprehensive overview of the new procedure, including the latest changes related to transparency. He will also discuss how this regulation will impact the management of clinical trials after approval has been granted, as well as ongoing trials that were approved under the previous Clinical Trial Directive. Join us to gain valuable insights into the latest regulatory landscape and learn how to navigate the new clinical trial authorization process effectively.
Who Should Attend
- Regulatory Affairs Manager
- Clinical Trial Manager
- Quality Assurance Specialist
- Clinical Research Associate
- Pharmacovigilance Officer
- Compliance Officer
- Clinical Operations Director
- GMP Compliance Manager
Meet The Trainer
Adriaan Fruijtier graduated as a pharmacist from the University of Utrecht, The Netherlands. Since April 2004, he has been an independent regulatory affairs consultant. Before this, he served as Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA, until March 2004. From 2001 to 2003, he was the Director of
Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet, he worked as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom, for four years. Adriaan transitioned to the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was the Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996, he spent six years as Head of Drug Regulatory Affairs at Ciba-Geigy in the Netherlands and also worked as Manager of Regulatory Affairs at
Glaxo, also in the Netherlands.
