Overview
Join us to deliberate the latest challenges and opportunities resulting from EMA, Health Canada and National Institutes of Health data disclosure & transparency policies, and gain insights on different approaches to navigate and comply with global disclosure and transparency requirements for medicinal products and medical devices.
We will also discuss the impact of the EU General Data Protection Regulation (GDPR) on data sharing; various strategies for preparing for the implementation of the EU Clinical Trials Regulation; the impact of Brexit on MHRA and disclosure requirements; how new ICMJE data sharing requirements are being implemented; what approaches sponsors are taking for redaction and anonymization; and updates on sponsor compliance.
This 2019 Conference builds on prior conference discussions and leverages learnings from Regulators and international experts in the field.
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Program Committee
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Julie Holtzople President
Holtzople Consulting, United States -
Merete Joergensen, MBA, MSc Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark -
Scott Feiner Senior Manager, Trial Disclosure
AbbVie, United States -
Robert Paarlberg, MS Principal
Paarlberg & Associates LLC, United States -
Matthias Zerm, PhD Lead Expert, Clinical Trial Disclosure and R&D Processes
Germany
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