The EU Clinical Trial Regulation

6.0
RAC Credits
Europe Europe Virtual Programs Virtual Programs
Friday, 18 February 2022 (8:30 AM) - Friday, 18 February 2022 (4:30 PM) Central European Time (CET)

On 31 January 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 will likely come into force and change the procedure for assessment and approval of multinational clinical trial authorization applications. As a result, a single authorization 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 clinical trials regulation, including rules on transparency.

During this workshop, Adriaan Fruijtier, of CATS Consultants will discuss important changes regarding the protection of subjects and provide a detailed overview of the new procedure. Additionally, he will explain how the new regulation will affect the way 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.


Pricing Amounts and Deadlines

Before 18 January 2022: Member € 555 | Nonmember € 650

After 18 January 2022: Member € 650 | Nonmember € 770


Learning Objectives

Upon completion of this workshop, participants will be able to:

  • Navigate the new regulatory landscape for clinical trial applications in the European Union.
  • Understand how the different stakeholders (sponsors, EMA, national competent authorities, ethics committees) interact.
  • Submit a clinical trial application under the new Regulation.

Agenda

8:30-9:00 a.m.  Welcome, introductions, and overview
9:00-9:45 a.m Current process of applying for clinical trial authorization in the EU
9:45-10:30 a.m. Voluntary harmonization procedure
10:30-10:40 a.m. Break
10:40-11:20 a.m. Clinical trial facilitation group (CTFG) and useful guidance
11:20-12:20 p.m. Overview of the new clinical trial regulation, part 1 (including paediatric trials)
12:20-1:15 p.m. Lunch break
1:15-2:00 p.m. Overview of the new clinical trial regulation, part 2
2:00-2:45 p.m. Requirements for IB and IMPD
2:45-3:00 p.m. Break
3:00-3:45 p.m. GMP requirements (including ATMP), QP for batch release
3:45-4:00 p.m. Review and conclusion

       

Speaker(s)

Adriaan Fruijtier, CATS Consultants

Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. Until March 2004 was 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 worked four years as a project manager for oncology projects at the European Medicines Agency (EMA) in London, UK.

He joined EMA 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 a manager of regulatory affairs at Glaxo, also in the Netherlands.


Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. 

Substitutions may be accepted with written approval from RAPS and must be submitted to support@raps.org. 


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