EU Clinical Trials Regulation: Anticipating the Changes

概览

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.

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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

EU Clinical Trials Regulation: Anticipating the Changes

概览

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学习目标

获得信息并保持参与