Clinical Trial Results Disclosure: What Have We Learned from EMA Policy 0070 Implementation and ClinicalTrials.gov Postings?
Robert Paarlberg, MS
Paarlberg & Associates LLC, United States
This session will discuss how companies are approaching the Policy 0070 and Final Rule requirements. The session will also provide the latest updates on Policy 0070 and the Final Rule from EMA and ClinicalTrials.gov staff. The panel will include representatives from EMA, National Library of Medicine (ClinicalTrials.gov) and industry speakers from mid-size and large pharma.
Learning Objective : Identify key areas impacted by the Final Rule and Policy 0070; Discuss approaches companies are taking in order to comply;Discuss challenges of Policy 0070; Describe experiences with redaction packages; Discuss how companies are approaching EMA and ClinicalTrials.gov document requirements; Identify best practices.
The Evolution of Clinical Data Transparency: Managing Policy 0070 Requirements of the Future to Maximize Compliant Efficiency
Accenture UK Ltd, United Kingdom
Disclosing Data: EMA Policies 0043/0070, EudraCT, and the Clinical Trial Regulation - Where Are We Now?
Marie Manley, LLM
Partner and Head of the Regulatory Practice
Bristows LLP, United Kingdom
Update from ClinicalTrials.gov
Rebecca J. Williams, PharmD, MPH
Assistant Director, ClinicalTrials.gov, NCBI
National Library of Medicine, NIH, United States