Clinical Trials Workshop II - Translating the New Transparency Requirements into Practice 2014

Key Topics

• Impact on preparation and update of CTA submissions by sponsors
• Key aspects of the present and new requirements on clinical trials with respect to disclosure and transparency of clinical trial information
• Role of European Commission and EMA and implementing measures
• Preparing redacted Clinical Study Reports (CSRs) and lay summaries in response to the EFPIA-PhRMA Principles, the new EMA policy, and the new Clinical Trials Regulation
• Public information in the EU Clinical Trials Register from the EudraCT database
• Entering study results into the EudraCT database versus ClinicalTrials.gov
• Industry scheme for clinical trial data sharing

Who should Attend

• The pharmaceutical industry and Contract Research Organisations including
  • Regulatory affairs personnel
  • Staff from clinical data disclosure, clinical science, and clinical operations
  • Staff from Legal, Patent departments and Scientific Intelligence
  • Pharmacovigilance staff
• Regulatory agencies
• Physicians
• Academic institutions
• Patient organisations