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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)
Rosalynd Cole
Senior Manager, Jazz Pharmaceuticals, United Kingdom
The Evolution of Clinical Data Transparency: Streamlined Project Management in the EMA’s Policy 0070 Space
Marie Manley
Partner, Head of EU and UK Life Sciences (UK), Sidley Austin LLP, United Kingdom
Disclosing Data: EMA Policies 0043/0070, EudraCT, and the Clinical Trial Regulation - Where Are We Now?
Rebecca Williams, PHARMD, MPH
Senior Clinical Trials Subject Matter Expert, Essex Management, Part of Emmes Group, United States
Update from ClinicalTrials.gov
Olivia Shopshear, MS
Senior Director, US Regulatory Policy Lead, Biogen, United States
Beyond Disclosure: Working Toward Better Outcomes for Patients
Ann M. Witt, JD
Counselor to DC for Policy, OND, CDER, FDA, United States
FDA’s Pilot to Enhance Transparency of Clinical Trial Information
Anne-Sophie Henry-Eude, PHARMD
Head of Documents Access and Publication Department, European Medicines Agency, Netherlands
EMA Update
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