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Session 2: Joint Session - Practical Implications of Transparency in CTIS
Session Chair(s)
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark
Nick Sykes, MS
Policy Advisor
EFPIA, Belgium
The session aims to cover the below topics through presentations and ample opportunity to ask questions and discuss with the panel: • CTIS Publication Rules: how CTIS supports access to clinical trial data – explanation and demonstration of the related CTIS functionality for sponsors and for public access • How sponsors are approaching the challenge of managing the deferral rules and preparing for the redaction/anonymisation of the ‘for publication’ documents. • Ensuring consistency of redaction/anonymisation between documents for publication via CTIS and via other EMA disclosure policies (Policy 70 and Policy 43).
Speaker(s)
CTIS Publication Rules: How CTIS Supports Access to Clinical Trial Data
Laura Pioppo, MSc
European Medicines Agency, Netherlands
Scientific Administrator, CTIS expert
Preparing for the redactions of the ‘for publication’ documents and challenges of managing the deferral rules: A Sponsors’ Perspective
Sameer Sharma, MPharm
Merck KGaA, Germany
Associate Director, Clinical Trial Transparency
Panel Discussion with Q&A and with the additional participation of:
Claudia Riedel
Federal Institute for Drugs and Medicinal Devices (BfArM), Germany
Head of the Clinical Trial Unit, Division of Scientific Services
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