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Preparing Clinical Documents for Public Release: The Issues of Transparency and Redaction
Session Chair(s)
Kerstin Dahlström, MPharm, MS
Director Transparency and Outsourcing
H. Lundbeck A/S, Denmark
EU Regulation No. 536/2014 (EMA policies 43+70) and EFPIA/PhRMA’s ’Principles for Responsible Clinical Trial Data Sharing’ are both initiatives to increase transparency of information on medical products and data on which regulatory decisions are based. The overall ambition is to support patients and society. However, we also have to protect patients’ privacy and safeguard personal data before sharing any information. This session will elaborate on this challenge but also give guidance on potential solutions and future ways of working.
Speaker(s)
De-Identification of Patient Data in Rare Disease Clinical Studies – Special Considerations
Adel Salem
Novo Nordisk, Denmark
Senior Programmer
The Impact of Clinical Trial Data Disclosure on Trial-related Documents: Redaction Requirements and Future Document Structure
Tracy Farrow
PPD, United Kingdom
Senior Director Medical Writing
How We Deliver It All Together – Reflections on Medical Writers’ Collaboration with Other Skill Groups
Kerstin Dahlström, MPharm, MS
H. Lundbeck A/S, Denmark
Director Transparency and Outsourcing
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