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Holiday Inn Bloomsbury

Oct 26, 2015 7:00 AM - Oct 27, 2015 5:00 PM

Coram Street, London, WC1N 1HT, United Kingdom

Clinical Trials Workshop

This 2-day workshop will provide a forum for information exchange and discussion on conceptual and practical questions through lectures and panel discussions.There will be a particular focus on the critical issues affecting sponsors and Member States as they consider the impact and changes needed to implement the regulation.

Session 7 How the clinical trial sponsors are working towards implementation and the issues they are facing?

Session Chair(s)

Mark  Rutter

Mark Rutter

Co-Founder, Head of Product Development & Strategy

RxTROSPECT, United States

This session will focus on the work being conducted, approaches being taken and the challenges being faced by sponsors as they are considering what needs to be done to ensure they implement the CTReg. Views from Commercial and non-commercial sponsors and CROs will be included. Panel discussion with Q&A

Speaker(s)

Adam  Smith

Connecting the EU Jigsaw: Creating the CTR Mindset

Adam Smith

F. Hoffmann-La Roche Ltd, Switzerland

Development Excellence Leader, Pharma Portfolio Management

John  Poland, PhD

Clinical Trial Regulation Readiness – Insight From the CRO Perspective

John Poland, PhD

Association of Clinical Research Organizations (ACRO), United Kingdom

Regulatory Affairs Consultant

Mark  Rutter

Company Readiness for the CTR: Key Considerations

Mark Rutter

RxTROSPECT, United States

Co-Founder, Head of Product Development & Strategy

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