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Session 2: Global Harmonisation- benefits and barriers
Session Chair(s)
Nate Root, MSc
Associate Director, Disclosure and Transparency
Ionis Pharmaceuticals, United States
The global harmonization session will cover a brief history of the ongoing harmonization efforts to date and an introduction to the new PHUSE Best Practice guide. Industry experts will be discussing how the COVID-19 pandemic has changed the global collaboration of regulators and opportunities to where this can translate into disclosure and data sharing, as there has been an increasing demand in transparency. In these challenging times, we want to ensure that information is being disclosed timely and appropriately, while abiding by current regulations and maintaining trial integrity on a global scale.
Speaker(s)
Global Harmonisation – an Industry Perspective
Julie Holtzople
Holtzople Consulting, United States
Independent Consultant
Global Clinical Trial Transparency and the Patient
Merete Joergensen, MBA, MSc
Merete-J Consulting, Denmark
Clinical Disclosure and Transparency Expert
Combined Panel Discussion with Q&A with Speakers from both Sessions 1 & 2, in addition to:
Nancy B. Sager, MBA
FDA, United States
Director, Division of Information Disclosure Policy, ORP, CDER
Combined Panel Discussion with Q&A with Speakers from both Sessions 1 & 2, in addition to:
Anne-Sophie Henry-Eude, PharmD
European Medicines Agency, Netherlands
Head of Documents Access and Publication Department
Combined Panel Discussion with Q&A with Speakers from both Sessions 1 & 2, in addition to:
Andre Molgat, PhD
Health Canada, Canada
Head of Operations, Public Release of Clinical Information