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Monday, June 27 • 10:45am - 12:00pm
#136: Clinical Data Disclosure and Transparency: ClinicalTrials.gov Final Rule, EU Requirements, and Other Key Updates

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will involve a panel and analyze the ClinicalTrials.gov Final Rule, discuss how companies are navigating the US and EU disclosure/transparency mandates, and discuss data sharing expectations.

Learning Objectives

Identify the requirements of the Final Rule expanding the ClinicalTrials.gov database; Describe how industry is navigating US and EU disclosure mandates; Discuss how companies are approaching data sharing expectations

Chair

Robert Paarlberg, MS

Speaker

Panelist
Rebecca J. Williams

Panelist
Marla Jo Brickman, PhD



Chair
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in global clinical trial disclosure strategy and operations, regulatory policy and regulatory intelligence. Bob has more than 35 years of industry experience in US and international regulatory affairs. Bob has been actively involved with clinical trial disclosure since 2005. Bob is Chair of DIA’s Clinical Trial Disclosure Community. He received a M.S. in... Read More →

Speakers
avatar for Marla Jo Brickman

Marla Jo Brickman

Senior Director/Team Leader, Clinical Trial Disclosure Group, Pfizer Inc
Marla Jo Brickman, PhD, is the Senior Director/Team Leader for the Clinical Trial Disclosure Group at Pfizer and serves as the global disclosure policy lead for all clinical trial registration and results disclosures, as well as, providing oversight of Pfizer’s implementation of the PhRMA/EFPIA principles. Marla received her PhD and completed her post-doctoral training in Immunology from Duke University, in Durham, NC.
avatar for Rebecca Williams

Rebecca Williams

Assistant Director, ClinicalTrials.gov, NCBI, National Library of Medicine, NIH
As the Assistant Director of ClinicalTrials.gov, Dr.Williams is responsible for the results submission process, outreach and education, policy and regulation development, and research related to evaluating and improving reporting of clinical research.


Monday June 27, 2016 10:45am - 12:00pm
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA