Life Sciences

CBI Publication and Clinical Trial Disclosure Forum

6/9/2014 | Event Brian Sharkey is speaking at the CBI Publication and Clinical Trial Disclosure Forum in Dublin, Ireland on June 9-10, 2014.  Brian will be a panelist speaking on Disclosure of Financial Support — The Impact on Medical Publications, Track I: Publication Planning, on Tuesday, June 10 at 1:45pm.

CBI Publication and Clinical Trial Disclosure Forum Highlights

Summit Description:
Similar to the Sunshine Act implemented in the U.S., other regulations governing the disclosure of financial support for the preparation of publications are taking hold throughout Europe. This session identifies the impact of these growing regulations on how medical publications are written and supported.

  • Transparency measures governing transfer of value in the EU
  • Payment reporting requirements
  • Implications to medical publications

The EMA’s recent announcement around transparency of clinical trial data marks one of the biggest developments in public disclosure. More pharmaceutical companies are committing to sharing patient-level data with third party researchers and investigators upon reasonable request, leaving many questions around global competitiveness, misuse of data, patient confidentiality and publication timelines.

Now in its third year, The Publication and Clinical Trial Disclosure Forum is designed for professionals working in publication planning and clinical trial disclosure to share strategies and benchmark plans for coordinating data sharing and ensuring transparency.

Key Topics:

  • Implications of the EMA data transparency and data sharing initiatives
  • Results posting procedures on the EudraCT database
  • The Editor perspective on working with industry and publishing data
  • How the Sunshine Act and other regulations affect financial disclosure of medical publications
  • Updated ICMJE authorship guidelines
  • Clinical data standardization of disparate sources and systems
  • Specific requirements and emerging developments of local and national registries
  • Collaboration between the disclosure and medical writing groups

For more information, please click here.