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RA Considerations During Clinical Development in the EU

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Thursday, 17 February 2021 (9:00 AM - 4:00 PM) Central European Time

Join Adriaan Fruijtier of CATS Consultants at the Hilton Rotterdam, The Netherlands on 17 February 2022 as he guides you through the writing of a regulatory plan, emphasizing which aspects you should consider. Several pathways to speed up development will be explored, such as PRIME and adaptive pathways.

Participants will learn to:

  • Create a comprehensive regulatory plan
  • Explain how to obtain and maintain orphan medicinal product status from the EMA
  • Explain the role of scientific advice and pediatric investigation plans in regulatory plan development

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 500metres 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.