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Opportunities for Harmonization of Clinical Trial Information in Regulatory Documents
Session Chair(s)
Robert Paarlberg, MS
Principal
Paarlberg & Associates LLC, United States
The global clinical trial transparency landscape has different requirements for disclosing clinical information. The COVID-19 pandemic has clearly illustrated the need for sponsors to expeditiously prepare clinical documents for submission to regulators under existing policies. This session will explore the challenges in submitting a more harmonized dossier to regulators and the public posting of clinical documents by regulators and opportunities for the future.
Learning Objective : Identify lessons learned from the recent COVID-19 experience and opportunities of harmonization in document submissions to regulators; Recognize the challenges to sponsors in preparing clinical documents for regulators in multiple regions; Discuss steps toward reaching a more harmonized approach.
Speaker(s)
Industry Update
Julie G. Holtzople
AstraZeneca, United States
Senior Director Clinical Transparency and Data Sharing
Health Canada Update
Melissa Jean
Health Canada, Canada
Scientific Reviewer, Public Release of Clinical Information
EMA Update
Radu Popescu, MD
European Medicines Agency, Netherlands
Scientific Administrator
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