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The EU Clinical Trial Regulation

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Thursday, 18 February 2021 (9:00 AM - 12:00 PM) Central European Time

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 in-person 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 17 January 2022: Member € 555 | Nonmember € 650

After 17 January 2022: Member € 650 | Nonmember € 770

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.

 

Location

Hilton Rotterdam

Weena 10, 3012 CM Rotterdam

The Netherlands

Accomodations

RAPS has secured a discounted room block at the Hilton Rotterdam for workshop attendees. Please mention that you are participating in the RAPS workshops.

Check-in time is 15h00. Although the hotel will make every reasonable effort to accommodate guests who arrive before the check-in time, the client recognizes that guest rooms may not be immediately available. Baggage storage will be available. The hotel check-out time is 12.00 on the day of departure.

Room Rate: € 165.00 per night

Room includes:

  • Complimentary breakfast
  • Free WIFI Internet for all in-house guests
  • Tax (VAT)

Book your discounted group rate here:

Access & Public Transport

The Hilton Rotterdam is located in the city centre, just 500 metres away from Rotterdam Central Station.

Airport

There is a direct train connection from Schiphol airport to Rotterdam central Station which takes about 26 minutes.

For real-time information, please visit the mobile website OV9292.

Taxi

Taxis are available directly from the airport outside the departure and arrival halls. You can choose a regular taxi, a luxury Schiphol Business Taxi or a Schiphol Travel Taxi minibus.

If you prefer to pre-order a taxi in advance, don’t hesitate to contact Schiphol Transfer Assistance (STA). Just call +31 20 601 3400 or visit the STA desk in Schiphol Plaza. You can find them in Arrivals 4, open anytime day or night.

Parking

The hotel has parking at a cost of € 30 per night.