戻る Agenda
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)
Julie Holtzople
Independent Consultant, Holtzople Consulting, United States
Global Harmonisation – an Industry Perspective
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert, Merete-J Consulting, Denmark
Global Clinical Trial Transparency and the Patient
Nancy B. Sager, MBA
Director, Division of Information Disclosure Policy, ORP, CDER, FDA, United States
Combined Panel Discussion with Q&A with Speakers from both Sessions 1 & 2, in addition to:
Anne-Sophie Henry-Eude, PharmD
Head of Documents Access and Publication Department, European Medicines Agency, Netherlands
Combined Panel Discussion with Q&A with Speakers from both Sessions 1 & 2, in addition to:
Andre Molgat, PhD
Head of Operations, Public Release of Clinical Information, Health Canada, Canada
Combined Panel Discussion with Q&A with Speakers from both Sessions 1 & 2, in addition to: