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Publication and Clinical Trials Transparency
June 27, 2017 - June 28, 2017
With more stringent focus on posting results publicly, it is a necessity to align the registration process, results release, report writing and publication. Now in its sixth year, CBI’s Publication and Clinical Trial Transparency congress is the only life sciences forum that convenes publication planning and clinical trial registry, transparency and disclosure professionals to share strategies and benchmark plans for coordinating results postings in registries and journals, ensuring transparency and compliance with global regulations.
Why This Conference? Why Now?
The regulatory environment is heating up with new and evolving developments within this space, including the mandatory EMA data sharing policy, expanded rulemaking for FDAAA, modified EudraCT database posting timelines, new EFPIA code on transfers of value, forthcoming Clinical Trials Regulation and pending GPP3 guidelines.
Industry is responding to these recent shifts together and CBI’s Publication and Clinical Trial Transparency congress provides much-needed best practice benchmarking and knowledge-sharing on publication and data sharing initiatives.
Benefit from Expert Insights On:
- Experiences and lessons learned from companies sharing patient-level data and posting to the EudraCT database
- Preparations for the public disclosure of transfers of value made to healthcare professionals and organizations
- Guidelines to prepare and deliver patient lay summaries
- Compliance with Good Publication Practice 3 (GPP3)
- Communicating the results of trials to investigators and patients
- Navigating varying posting requirements on ClinicalTrials.gov, EudraCT and other local registries
- Avoiding open access fraudulent publishing
- Discussing initial experiences with the posting requirement from NIH Final Rule of FDAAA
- The redaction of clinical study reports (CSRs) for patient confidentiality
- Analyzing the legal status of EMA Policy 0070