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Work programme 2017

WC500221614

Objective 2: Convergence

Objective 2: Convergence of global standards and contribution to international fora Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Improve application of 4.2-1 Develop (through relevant inspector Contin Contin High - Network approach to inspections and equivalent standards of good working groups) and apply an uous uous training collaboration agreed, with manufacturing and clinical practices throughout the world integrated and consistent approach to cooperation with key authorities (such particular focus on China and India - agreed procedures for cooperation as China and India) 4.2-2 Invite non-EU regulators to relevant Contin Contin High - increase in number of non-EU Harmonisation of international standards and approaches Facilitate effective informationsharing by using international electronic standards Promote uptake of harmonised standards for veterinary medicines at international level training activities and to observe GCP and GMP inspections 4.2-3 Leverage the technical, procedural and scientific advancements resulting from the EU pharmaceutical legislation to improve convergence with other regions 4.2-4 Implement first iteration of international electronic standards within the EU, and extend to non-EU countries 4.2-5 Consider international scientific approaches for the establishment of MRLs for harmonisation purposes 4.2-6 Participate in training events that raise awareness and enhance uptake of VICH standards by non-VICH countries uous uous inspectors participating in relevant training activities - increase in number of non-EU observers participating in inspections 2017 2019 High - systematic reporting to WHO of EU ADR reports and use of EU pharmacovigilance products by non-EU regulators, such as medical literature monitoring and on single assessment periodic safety update reports 2012 2019 High - implementation plan agreed - increase in the number of international partners using the standards 2016 2019 Medium - a report on the outcome of discussions with Codex Alimentarius presented to the CVMP 2016 2019 Medium - EU systems and approach presented at international training events Work programme 2017 EMA/583016/2016 Page 38/123

Contributing to European and 4.2-7 Implement a structured approach to 2016 2017 Medium - registration to EMAS, eco-friendly Compliance with global standards international initiatives and collaborations regarding environmental friendliness environmental management, with objective-setting and monitoring, with a target to reduce the carbon footprint of the Agency's activities management system International cooperation mechanisms Ensure appropriate representation in relevant fora, to ensure convergence of standards 4.2-8 Implement mechanisms to ensure representative and consistent representation of the network in international fora, and to provide feedback to the network, including ICH, VICH, WHO, OIE, IRCH and PIC/S, ICMRA, IPRF, IGDRP 2017 2019 Medium - mechanism to ensure participation and feedback through pharmaceutical committee and HMA agreed Use of animals in medicines development Minimise use of animals in medicines research and development activities 4.2-9 Contribute to the development of internationally harmonised guidance by VICH on applying the 3Rs approach to batch-testing of veterinary vaccines and other relevant areas 4.2-10 Improve the guidance available on regulatory acceptance of 3R principles in testing approaches 2014 2020 Medium - completed guidelines on applying 3R 2014 2017 Medium - availability of up-to-date guidance Work programme 2017 EMA/583016/2016 Page 39/123

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