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Virtual

Nov 18, 2020 1:45 PM - Nov 19, 2020 7:00 PM

(Central Europe Standard Time)

Clinical Trial Regulation Conference

Session 2: Joint Session - Practical Implications of Transparency in CTIS

Session Chair(s)

Merete  Joergensen, MBA, MSc

Merete Joergensen, MBA, MSc

Clinical Disclosure and Transparency Expert

Merete-J Consulting, Denmark

Nick  Sykes, MS

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)

Laura  Pioppo, MSc

CTIS Publication Rules: How CTIS Supports Access to Clinical Trial Data

Laura Pioppo, MSc

European Medicines Agency, Netherlands

Scientific Administrator, CTIS expert

Sameer  Sharma, MPharm

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

Claudia  Riedel

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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