1 year ago

Work programme 2017


• EU Network Training

• EU Network Training Centre. This is a joint EMA/HMA initiative to harmonise training in Europe through implementing a common online platform for scientific and regulatory training, accompanied by a training strategy, curriculum and methodology. • Information and transparency. The Agency places high importance on the transparency, openness and efficiency of its interactions with partners and stakeholders. The Agency maintains and manages specific communication and information exchange platforms, and provides up-to-date information to its stakeholders, partners and the general public on its work and outputs as well as important subject matters and developments, including lay-language summaries on medicines and regulatory outcomes. This information is also shared within the European regulatory network in advance of publication in order to ensure that consistent messages on medicines are available to citizens across the EU. In addition to the activities described above, public access to documents and information is provided in accordance with Regulation (EC) No 1049/2001, and the number of requests for access to documents is continuously increasing. • Communication activities. The Agency's communication activities aim at supporting the Agency's mission of protecting public and animal health and the achievement of its strategic priorities. The Agency uses a range of channels with its corporate website,, as the main channel. The Agency fosters productive relationships with the media, both general and specialist, through the provision of press materials, organising media interviews and press conferences, and responding to journalists' queries. The Agency has put in place a dedicated, centralised service to respond to queries received from patients, healthcare professionals and academia. The Agency's social-media activities include communication via a Twitter account and regular updates on LinkedIn and YouTube. Drivers The process of regulating medicines is becoming increasingly complex, with a multitude of stakeholders involved from the early stages of development through to patients accessing and using these medicines. As EMA enhances its efforts to share knowledge and information with the NCAs, patients, healthcare professionals, the media and other stakeholders, the central coordination role of the Agency becomes increasingly important. Increasingly complex environment of operations and interactions emphasises the need for EMA to increase its visibility in this space to ensure that its public-health messages continue to be heard and understood. The success of an increasing number of EMA initiatives depends on the Agency's ability to effectively engage with stakeholders and audiences, including those not yet familiar with the organisation. Clear communication using the right channels to provide meaningful content to these stakeholders is a prerequisite for any outreach activities by the Agency. Academia, SMEs and public-private partnerships are an increasingly important source of innovation in medicines. The ongoing work within the European medicines regulatory network to strengthen early support for innovative medicines, teamed with the roll-out of further funding opportunities, such as the SME instrument within Horizon 2020, will mean the number of SMEs registered with the EMA for assistance should continue to grow. The Agency will consider how to further reinforce its development support to these stakeholder groups, taking into account the 10 years of experience accumulated within the SME Office. There will also be a need to offer assistance to SMEs in the areas of pharmacovigilance and clinical-data transparency. Proactive publication of clinical reports (submitted as part of marketing-authorisation applications and applications for line extensions/extensions of indication) under the 2014 EMA policy on publication of clinical data for medicines for human use started in 2016. SMEs are provided with specific support to Work programme 2017 EMA/583016/2016 Page 88/123

meet the policy's requirements. In 2017, the Agency will monitor the implementation of the policy and publish a report. An independent communication perception survey conducted on behalf of the Agency in 2015 highlighted the need to produce more targeted communications using a wider range of tools and platforms, as well as to further engage with different groups of users via electronic communication channels and via social media. This is particularly pertinent in the area of medicine-related information. The increasing involvement of and demand from key stakeholders, including patients and healthcare professionals, for easily usable and reusable up-to-date information requires the use of simplified messages and more user-friendly communication tools and platforms. Recent user research confirms that patients are taking ever greater control of healthcare decisions and choices, basing these choices on a range of online information sources. Delivering clear, coordinated messages via appropriate communication channels will be key to facilitating access to timely, authoritative, consistent, reliable and understandable information on medicines by the public across the EU. The multitude of traditional and social media contributing to an ever accelerating news cycle means that the reputation of an organisation is under threat at any time. Safeguarding EMA's reputation requires continuous monitoring of press and social media, as well as the ability to respond quickly and effectively to public concerns. Workload indicators Results Forecasts 2014 2015 2016 2017 Requests for SME qualification 499 793 582 650 SME status renewal requests 813 994 1,185 1,400 Number of cases of patient/consumer engagement 1 in EMA 633 743 750 700 activities New scientific, regulatory and telematics curricula developed n/a 1 8 0 Number of training events advertised to the EU Network n/a 105 140 170 Number of reimbursed training events to the EU Network n/a 7 25 25 Number of messages circulated via 'Early Notification System' 317 310 380 400 Number of EMA communications pro-actively sent to 135 138 172 200 stakeholders Number of EPAR summaries and EPAR summaries updates 260 340 283 300 published Number of summaries of orphan designation published 218 230 240 250 Access to documents, requests received 416 701 823 850 Access to documents, documents released 1,771 2,972 2,876 2,500 Requests for information received 4,625 4,573 4,843 4,800 Number of documents published on EMA website 4,858 7,154 7,369 7,000 Number of pages published and updated on EMA website 2,201 2,911 4,790 3,500 Number of press releases and news items published 190 197 150 Requests for interviews and comments by media 2,384 2,268 2,149 2,000 representatives Number of reports, brochures, leaflets laid out or printed 7 25 2 6 Work programme 2017 EMA/583016/2016 Page 89/123

2017 Work Programme
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