RA Considerations During Clinical Development in the EU

6.0
RAC Credits
Virtual Programs Virtual Programs Europe Europe
Thursday, 17 February 2022 (8:30 AM) - Thursday, 17 February 2022 (4:30 PM) Central European Time (CET)

There are myriad elements that factor into the development of regulatory strategy. This workshop will provide an analysis of writing of a regulatory plan, emphasizing which key aspects to consider. Several pathways to expedite development will be explored, such as PRIME and adaptive pathways.

Among the topics to be discussed are:

  • Qualification as an orphan drug, and subsequent benefit from incentives,
  • Selecting between national and EU scientific advice,
  • Paediatric studies and investigation plans.

Pricing Amounts and Deadlines

Before 17 January 2022: Member € 555 | Nonmember € 650

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

Learning Objectives

Upon completion of this workshop, participants will be able 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 paediatric investigation plans in regulatory plan development.

Agenda

8:30-9:00 a.m.

Welcome, introductions, and overview

9:00-10:15 a.m.

Regulatory strategy & regulatory plans, including PRIME

10:15-10:30 a.m.

Break

10:30-11:15 a.m.

Applying for orphan designation

11:15-12:00 p.m.

Maintenance of orphan designation

12:00-1:00 p.m.

Lunch break

1:00-2:00 p.m.

Scientific advice

2:00-2:15 p.m.

Break

2:15-3:00 p.m.

Paediatric development

3:00-3:45 p.m.

Case studies

3:45-4:00 p.m.

Review and conclusion

Speaker(s)

Adriaan Fruijtier is an independent regulatory affairs consultant, helping companies develop global regulatory strategy. With a career spanning more than 30 years, he initially studied to be a pharmacist before joining the field of regulatory affairs, where Adriaan specialized in oncology and immunology. He has worked with several companies throughout his career, including Ciba-Geigy B.V., Glaxo B.V., Novartis AG, Micromet AG, and Bayer AG, where he was the head of the oncology group within global regulatory affairs. Additionally, Adriaan spent nearly four years as a project manager at the European Medicines Agency in London. Adriaan has authored more than 15 publications and delivered countless presentations and workshops for the regulatory affairs profession.

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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