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Work programme 2017

WC500221614

Additional objectives

Additional objectives and activities In addition to delivering its regular activities regarding inspections and compliance, the Agency plans to undertake and progress the following activities: Medium-term objective MAWP initiative Activity description Timeframe Start End Increase efficiency, consistency, quality and coverage of inspections through enhanced international cooperation and reliance on inspections by trusted authorities Minimise risk and impact of shortages due to manufacturing problems and quality defects Ensure quality of medicines wherever they are manufactured Improve application of equivalent standards of good manufacturing and clinical practice throughout the world Improve knowledge and understanding of data integrity 4.3-2 Strengthen collaboration on GCP and pharmacovigilance compliance and inspections activities in areas of particular interest, based on mutual reliance with trusted international partners, in particular those with confidentiality agreements in place (e.g. FDA and Japan) Continue to provide support to EC on negotiations work to establish a mutual reliance framework with US FDA 4.3-2 Set up a pilot phase with FDA on sharing 4.3-4 information on pharmacovigilance inspections 4.1-5 Implement EudraGMDP instruction rules for planning module to enable increased cooperation with Member States in coordinating third-country inspections 1.1-17 Implement the new form for reporting quality defects/suspected falsified medicinal products and start compiling information received, to analyse root causes for quality defects 1.1-14 Provide regulatory support to the work of the EU Observatory to facilitate the transition from high enriched uranium to low enriched uranium 1.1-20 Support and collaborate with HMA on the availability of medicines initiative 1.1-15 Develop a new procedure within the Compilation of Union Procedures for issuance of warning letters by Member States in case of non-compliance issues through the GMDP IWG 4.1-4 Monitor and report on the use of EudraGMDP planning module by inspectorates 4.1-6 Publish risk-based approach to GMP inspection for plasma master file inspections 4.2-1 Support training activities in India and China, including establish a panel of European inspectors available to participate in capacitybuilding workshops in these countries 4.1-2 Develop a draft guidance for industry on data integrity with the GMDP IWG and in Before 2018 2016 Before 2017 2015 2015 2018 2017 2018 2015 2019 2014 2019 2017 2019 2017 2019 2016 2017 2017 2018 Continu Continuo ous us 2017 2018 Work programme 2017 EMA/583016/2016 Page 86/123

Medium-term objective MAWP initiative Activity description Timeframe Start End and implications for regulatory decision-making Address the threat posed by illegal supply chains of medicines Support capacity building of non-EU regulators Strengthen collaboration with EDQM collaboration with PIC/s 1.1-16 Review the practical use of the existing Rapid Alert mechanism for transmission of information related to stolen and falsified medicines 4.4-1 Deliver training and capacity-building for inspectors and assessors, including international regulators 3.4-3 Review collaboration with EDQM to enable the 1.1-19 updated contract to be signed 2017 2019 Before 2018 2016 2017 2018 Resources 2017 Financial resources (cost, thousand Euro) 15,886 Human resources (FTEs) 41 3.3. Partners, stakeholders, communication and transparency Activity area Activities covered in this area include the following: • Interactions with partners. In order to deliver its mission, the Agency collaborates with national competent authorities in Europe, the European Commission, other EU institutions and EU agencies, and health technology assessment (HTA) bodies. These interactions range from exchange of information, qualification of novel methodologies with HTA bodies, and collaboration on guideline and standards development, to capacity-building, providing scientific expertise in the evaluation processes, cooperation on inspections, and other areas. • Stakeholder interactions with patients, healthcare professionals, industry organisations and academia. The interactions involving patients and healthcare professionals range from information and consultation to participation in the scientific activities of the Agency and its committees, and review of information intended for the public. The Agency is also developing its collaboration with academia, with a particular focus on innovation in medicines, such as qualification of biomarkers and new methodologies. • Micro, small and medium-sized enterprises. The Agency has an office specifically dedicated to supporting smaller companies, the SME Office. It provides eligible SMEs with access to various incentives and regulatory assistance, including fee reductions, deferrals and conditional exemptions, administrative and procedural support, as well as assistance with translations of the product-information documents submitted in applications for marketing authorisation. Around 1,450 SMEs are registered with the Agency. Work programme 2017 EMA/583016/2016 Page 87/123

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