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Session 3 Track D: The Broad Global Impact of EMA’s Transparency Policy
Session Chair(s)
Robert Paarlberg, MS
Principal
Paarlberg & Associates LLC, United States
The European Medicines Agency's (EMA) Publication Policy 0070 enables public access to clinical overviews, clinical summaries and clinical study reports included in a Marketing Authorization (MA) or Postmarketing Authorization. Clinical data that were submitted under the centralized procedure after January 1, 2015, (including clinical trials conducted outside the EU or EEA that were included in the MA) will be posted on the EMA website. Under Policy 0070, companies must balance public health interests while ensuring the privacy of patients identified in regulatory submissions.
This session will provide an early assessment of Policy 0070, highlight some potential challenges encountered in the de-identification of patient data, and discuss the challenges in writing a clinical study report with disclosure in mind.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss the current status of EMA Publication Policy 0070
- Recognize the potential risks of jeopardizing personal privacy by disclosing specific clinical trial patient data
- Discuss how clinical study reports can be written with disclosure in mind
- Describe the challenges of redacting commercially confidential information and anonymization of personal data in clinical study reports
Speaker(s)
EMA’s Clinical Data Transparency Policy – Where Are We?
Robert Paarlberg, MS
Paarlberg & Associates LLC, United States
Principal
Options for Data Sharing: Industry Implementation
Helle Gawrylewski, MA
Hawkwood Consulting, LLC, United States
Owner
Best Practices for Writing Clinical Study Reports for Disclosure
Ann Winter-Vann, PhD
Whitsell Innovations, Inc., United States
Senior Writer and Manager
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