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Overview

This pre-conference short course will bring you up-to-date with current developments and preparations for the implementation of the new clinical trial regulation so far. The course will complement the knowledge and information you’ll receive within the following conference days. It is recommended to take part if you did not attend last year’s clinical trial regulation conference.

Featured topics

Workshop Chair:

Sini Eskola,Director Regulatory Affairs, EFPIA

12:00   Registration

13:00   Introduction including Roadmap for EU CTR implementation

  Sini Eskola,Director Regulatory Affairs, EFPIA

13:30   EU CTR: preparing the organisation for change - a Sponsor perspective

 Adam Smith, Development Excellence Leader; Roche, Switzerland

14:45   EU CTR: preparing for change - a CRO perspective

          John Poland, Association of Clinical Research Organizations, UK

15:30   Refreshment Break

16:00   EFPIA CTiMonitor

            Sini Eskola,Director Regulatory Affairs, EFPIA

16:40   VHP as a stepping stone to CT Reg: Sponsor perspective

  Claire Berry, Roche, Switzerland

17:20   Wrap Up

 Sini Eskola,Director Regulatory Affairs, EFPIA

17:30   End of the Workshop

Learning objectives

  • You will be up to date on current preparations for the implementation of the new clinical trial regulation
  • Understand the top line implementation challenges faced by sponsors, CROs, and member states