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Clinical Trial Disclosure and Data Transparency Conference
Session 2: Access to Regulatory Clinical Documents: Sponsors’ Experiences
Patricia A. Teden, MBA
- President and Principal
- Teden Consulting LLC, United States
This is the second session on Access to Regulatory Clinical Documents, and focuses on the Sponsors’ experience. Both the EU and US require regulatory documents be made available on public portals, and Canada announced their intention to do the same. These requirements raise issues regarding protecting personal confidentiality and corporate confidential information. Initial standards have been documented by a few groups, and ‘tested’ by actual experience posting documents on the EMA’s website. This session will focus on the experience of sponsors who have prepared and posted regulatory clinical documents, including technical issues (such as redaction), corporate process issues, and communication with regulators.
Learning Objective :
Julie G. Holtzople
- Clinical Trial Transparency Operations Director
- AstraZeneca, United States
- Regulatory Intelligence Manager
- Novartis Pharmaceuticals Corporation, Switzerland
Q&A Panel Discussion
- All Session Speakers, United States