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DIA 2021 Global Annual Meeting


Opportunities for Harmonization of Clinical Trial Information in Regulatory Documents

Session Chair(s)

Robert  Paarlberg, MS

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)

Julie G. Holtzople

Industry Update

Julie G. Holtzople

  • Head of Clinical Transparency and Data Sharing
  • AstraZeneca, United States
Melissa  Jean

Health Canada Update

Melissa Jean

  • Scientific Reviewer, Public Release of Clinical Information
  • Health Canada, Canada
Radu  Popescu, MD

EMA Update

Radu Popescu, MD

  • Scientific Administrator
  • European Medicines Agency, Netherlands