US and EU Regulatory Update of Clinical Trial Disclosure
Track
:
Track 08:Regulatory Affairs and Submissions
Program Code:
254
Date:
Tuesday, June 25, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
254AB
CHAIR
:
Barbara Godlew, RN (SCHNON), President, The FAIRE Company, LLC, United States
Barbara Godlew provides senior-level consulting to the pharmaceutical industry and academic medical centers on clinical trial disclosure policy/ process development, operations implementation/management, and medical writing. Barbara is past Chair of the Clinical Trial Disclosure SIAC at DIA.
SPEAKER
(S):
Rebecca J. Williams, PharmD,MPH (SPKAGY), Assistant Director, ClinicalTrials.gov, National Library of Medicine, National Institutes of Health (NIH), United States
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.
Fergus Sweeney, PhD (SPKAGY), Head of Sector, Compliance and Inspection, European Medicines Agency, European Union, United Kingdom
PhD in pharmacology 1986 Joined EMEA in 1999. Coordination of GCP and Pharmacovigilance inspection. Chairman of the GCP Inspectors Working Group and Ad Hoc Pharmacovigilance Inspectors Working Group. Business analyst for the EudraCT database.
Description
This session focuses on US and EU requirements for clinical trial disclosure, including results reporting. Information obtained during this session applies to regulatory, clinical operations, medical writing, patient advocacy and other areas.