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Virtual

Nov 16, 2020 3:00 PM - Nov 18, 2020 7:30 PM

(Central Europe Standard Time)

Global Clinical Trial Disclosure & Data Transparency Conference

Session 2: Global Harmonisation- benefits and barriers

Session Chair(s)

Nate  Root, MSc

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

Global Harmonisation – an Industry Perspective

Julie Holtzople

Holtzople Consulting, United States

President

Merete  Joergensen, MBA, MSc

Global Clinical Trial Transparency and the Patient

Merete Joergensen, MBA, MSc

Merete-J Consulting, Denmark

Clinical Disclosure and Transparency Expert

Nancy B. Sager, MBA

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

Anne-Sophie  Henry-Eude, PharmD

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

Andre  Molgat, PhD

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

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