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Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program
Session Chair(s)
Robert Paarlberg, MS
Principal
Paarlberg & Associates LLC, United States
Identify key areas impacted by Policy 0070 and the NIH Final Rule, challenges and approaches for compliance; Describe experiences with redaction packages; Discuss how companies are approaching EMA, ClinicalTrials.gov and FDA’s new pilot clinical document requirements and identify best practices.
Learning Objective : Identify key areas impacted by Policy 0070 and the NIH Final Rule, challenges and approaches for compliance; Describe experiences with redaction packages; Discuss how companies are approaching EMA, ClinicalTrials.gov and FDA’s new pilot clinical document requirements and identify best practices.
Speaker(s)
The Evolution of Clinical Data Transparency: Streamlined Project Management in the EMA’s Policy 0070 Space
Rosalynd Cole
Jazz Pharmaceuticals, United Kingdom
Senior Manager
Disclosing Data: EMA Policies 0043/0070, EudraCT, and the Clinical Trial Regulation - Where Are We Now?
Marie Manley
Sidley Austin LLP, United Kingdom
Partner, Head of EU and UK Life Sciences (UK)
Update from ClinicalTrials.gov
Rebecca Williams, PHARMD, MPH
Essex, part of Emmes Group, United States
Senior Clinical Trials Subject Matter Expert
Beyond Disclosure: Working Toward Better Outcomes for Patients
Olivia Shopshear, MS
Biogen, United States
Senior Director, US Regulatory Policy Lead
FDA’s Pilot to Enhance Transparency of Clinical Trial Information
Ann M. Witt, JD
FDA, United States
Counselor to DC for Policy, OND, CDER
EMA Update
Anne-Sophie Henry-Eude, PHARMD
European Medicines Agency, Netherlands
Head of Documents Access and Publication Department