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Work programme 2017

WC500221614

Programme / Legal basis

Programme / Legal basis Start End Deliverables 2017 Project date date Clinical Trials programme EU portal and clinical trials database • Regulation (EC) 536/2014, art.80-82 Safety reporting • Regulation (EC) 536/2014, art.40-43 EudraCT and EU Portal • Regulation (EC) 536/2014, art.80-82, 98 Q3 2014 2018 • Delivery of fully functional system (i.e. EU portal and database) ready for audit • Initiation of audit of EU portal and database • Preparation of training materials and delivery of training to stakeholders • Preparation of user guidance documentation • Implementation of communication plan Q4 2014 2019 • Final business case completed for approval • Integration of safety reporting business requirements for the data warehouse with the EU portal and database requirements and EudraVigilance data warehouse 2017 2019 • Initial business case completed for approval • Design completed • Final business case completed for approval eCollaboration programme eCTD 4 preproject activities Single submission portal and integration (external project activities) Standalone projects AddValue: raising the standard of scientific output n/a 2017 2017 • Environmental analysis to examine available eCTD4 tools • Impact assessment to provide an estimation of cost for adapting the EMA systems to eCTD4 n/a Q3 2016 2018 • Provide centralised business subject matter expertise for integration of the human initial marketing authorisation application form in the CESP via the existing EUTCT, and EMA master data and controlled terminology n/a Q3 2015 2017 • Support tools and processes aimed at obtaining consistently high standards of scientific quality and robustness for key EMA scientific outputs, focussing on the marketing authorisation application assessment report • Support tools and processes to ensure consistency of assessment and decision-making throughout the process, along the life-cycle and across medicinal products • Standards for scientific quality of assessment reports with a special focus on how to best document the scientific rationale behind decisions • Mechanisms for continuous improvement of assessment reports Work programme 2017 EMA/583016/2016 Page 64/123

Programme / Project Legal basis Start date End date Deliverables 2017 • Recommendations for feasible approaches to increase the involvement of patients and the integration of their values into the body of assessment work (methodologies for benefit-risk evaluation and graphical representation) Work programme 2017 EMA/583016/2016 Page 65/123

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