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Tuesday, June 29 • 2:00pm - 3:00pm
#241 SL: Opportunities for Harmonization of Clinical Trial Information in Regulatory Documents

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-577-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Robert Paarlberg, MS

Speaker

Industry Update
Julie G. Holtzople

Health Canada Update
Melissa Jean

EMA Update
Radu Popescu, MD



Speakers
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC, United States
Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB... Read More →
avatar for Julie Holtzople

Julie Holtzople

Head of Clinical Transparency and Data Sharing, AstraZeneca, United States
Julie Holtzople is the Head of Clinical Transparency and Data Sharing for AstraZeneca. Prior to joining AstraZeneca, Julie worked as a management consultant in the health care industry to deliver systems, process improvements, and change and program management. As Head of Clinical... Read More →
MJ

Melissa Jean

Scientific Reviewer, Public Release of Clinical Information, Health Canada, Canada
RP

Radu Popescu

Scientific Administrator, European Medicines Agency, Netherlands
Radu Popescu has been with the European Medicines Agency (EMA) for more than 10 years and worked in various positions. Currently, he is a member of the Documents Access and Publication Service. Following the completion of his medical training he was attracted by clinical research... Read More →


Tuesday June 29, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session