Clinical Trials Workshop II - Translating the New Transparency Requirements into Practice 2014 covers topics such as:
- 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
Clinical Trials Workshop II - Translating the New Transparency Requirements into Practice 2014 brings together:
- 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
