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Work programme 2017

WC500221614

Increase collaboration

Increase collaboration with 3.4-4 Involve patients, HCPs and academia 2016 2020 High - increase in number of patients, HCPs civil-society representatives more, to further integrate clinical practice and real-life experience of and academia involved in EMA activities - frameworks for interaction with patients disease and its management along a and HCPs and/or action plans revised, Collaboration with stakeholders Streamline interactions with corporate stakeholders medicine's lifecycle 3.4-5 Increase engagement with GPs, thus fostering interaction with primary care 3.4-6 Formalise and structure interactions with pharmaceutical industry associations taking into account experience gained - framework for collaboration with academia implemented 2016 2019 Medium - virtual expert group with GPs created - number and implementation level of joint recommendations between EMA/UEMO/EFPC/WONCA for GPs' involvement in EMA activities 2016 2020 High - framework for interaction with corporate stakeholders implemented Work programme 2017 EMA/583016/2016 Page 36/123

Theme 4: Contributing to the global regulatory environment Objective 1: Assure product supply chain and data integrity Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Ensure adequate control and monitoring through all stages of 4.1-1 Increase information-sharing between regulators responsible for oversight of Contin uous Contin uous High - timely sharing of relevant information related to GMP inspections, quality the manufacturing and supply different stages of manufacturing defects and shortages chain Improve knowledge and understanding of data integrity, 4.1-2 Develop guidance on data integrity in collaboration with PIC/s 2017 2018 High - draft guidance published and implications for regulatory decision-making 4.1-3 Develop joint communication and training in collaboration with the FDA 2016 2018 High - joint communication material developed - one joint training session per year Supply chain and data integrity Ensure quality of medicines wherever they are manufactured 4.1-4 Develop a procedure to facilitate populating the EudraGMDP Planning module 4.1-5 Develop a procedure for the coordination of inspections in third countries, to make best use of network resources 4.1-6 Implement a risk-based approach to PMF inspections delivered 2016 2017 High - information on planned GMP inspections systematically introduced in the existing EudraGMDP planning module by inspectorates 2017 2019 Medium - increased coverage of GMP inspections in third countries, using fewer network resources 2012 2018 Medium - implementation level of the risk-based approach to PMF inspections Work programme 2017 EMA/583016/2016 Page 37/123

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