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15:00 CET        Welcome and Introduction

15:10    ICHE8R1 – General Considerations for Clinical Studies – What Do You Need To Know?

Andy Lawton (Risk Management & Quality by Design Consultant)

15:40    Unifying and Harnessing the Voice of The Global Clinical Research Site Community

Vivienne van de Walle (Society for Clinical Research Sites – SCRS)

 16:10    Clinical Research Excellence in Practice – A Site’s Perspective

Dr Kim Narunsky (University of Cape Town, Lung Institute)

 16:40    PCMG Star Awards – Share Your Experience of Overcoming an Outsourcing Challenge

Gill Slater – (Chair Pharmaceutical Contracts Management Group)

 16:50    Next Steps

 17:00    Close

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