1 year ago

Work programme 2017


Medium-term objective

Medium-term objective MAWP initiative Activity description Timeframe Start End Ensure a more optimal organisation of the available expertise within the network for services provided to EMA Ensure 'fit-for-purpose' scientific capability of the network Provide stakeholders and partners with consistent, high quality, timely, targeted and accessible information on Agency work, outputs and medicinal products revised policy on access to documents 3.1-5 Monitor and improve implementation of the multinational assessment team (MNAT) approach pre-authorisation 3.1-6 Implement the first phase of the multinational assessment team approach post-authorisation 3.1-3 Work with NCAs to include training courses in NTC learning management system and promote use of NTC courses, to maximise the use of the EU NTC learning management system 3.1-2 Review and update existing curricula to ensure provision of up-to-date training, and further develop new curricula in various areas of identified needs 3.3-6 Review and improve the format and content of EMA information on medicines for patients and healthcare professionals (i.e. EMA summaries in lay language) 1.4-6 Implement and maintain up-to-date 'productrelated communication guidance' on 'what' 3.3-6 and 'when' EMA publishes information on products Implement a framework for communicating the scientific output of EMA scientific committees 3.3-6 Implement user-testing for EMA 3.3-7 communication products which target the general public 3.3-10 Run a pilot to test and improve the crisis communication plan 3.3-8 Organise workshop with HCIN to explore additional ways to assess impact of EMA communications 3.3-7 Carry out an EMA perception survey to better understand communication opportunities and challenges, and review the Agency's communication products and tools as per the results of the survey 3.3-3 Improve the corporate website by adding new tools and features, such as tools to improve search, search-engine optimisation, accessibility, analytics and others 3.3-5 Develop new digital and multimedia communication tools 2016 2020 2016 2019 2015 2019 2015 2017 2016 After 2017 2016 2017 2016 2017 Before After 2016 2017 2017 After 2018 2017 2017 2017 After 2017 2016 After 2017 2016 After 2017 Work programme 2017 EMA/583016/2016 Page 92/123

Medium-term objective MAWP initiative Activity description Timeframe Start End 3.3-1 Develop and implement an annual Q1 2017 2017 communications plan, in line with the framework strategy for external communication 3.3-4 Implement a social media strategy Before 2016 After 2017 Resources Area of activity Financial resources (cost, thousand Euro) 2017 Human resources (FTEs) 2017 Partners and stakeholders 11,241 38 Transparency and access to documents 4,831 21 Information 3,137 14 Communication 6,771 28 3.4. International activities Activity area In its work, the Agency collaborates with non-EU competent authorities and regulators (US FDA, Japanese PMDA/MHLW, Australian TGA, Health Canada, Swissmedic and others), as well as international organisations and forums (such as EDQM, WHO, ICH, ICMRA, VICH, OIE, ISO, HL7, IPRF and others). These interactions span most of the activities of the Agency, and activities covered in this area include the following: • Regular exchanges of information on products, guidelines, policies, approaches and other activities take place across the lifecycle of the product and in all therapeutic and product areas. • Specific collaborative projects, such as provision of parallel scientific advice (human and veterinary) with the FDA, qualification of novel methodologies, joint collaboration on orphan medicines, biosimilars, paediatric and advanced therapies, and in the area of nanomedicines. The potential for further international work-sharing has led to additional cooperation activities, particularly in the areas of inspections, pharmacovigilance and signal-detection, as well as in transatlantic efforts to combat antimicrobial resistance and on generic medicine evaluation. • Supporting the evaluation of medicines intended for use in developing countries. The Agency has a specific legislative responsibility (Article 58 provision) to collaborate with the WHO on providing opinions for the evaluation of medicines intended for markets exclusively outside the European Union. • Supporting the capacity building and training of non-EU regulators through providing access to the scientific and regulatory training events organised by the EU Network via the EU Network Training Centre. Work programme 2017 EMA/583016/2016 Page 93/123

2017 Work Programme
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