1 year ago

Work programme 2017


Benefit-risk assessment

Benefit-risk assessment Increase involvement of stakeholders in relevant regulatory activities 1.2-6 Capture and incorporate patients' values and preferences into the scientific review process, in particular in benefit-risk evaluation 2016 2019 High - processes to capture such values and preferences developed and implemented - increased number of cases where patient and healthcare professional input is incorporated in the scientific review - number of patients involved in benefitrisk evaluation Objective 3: Support for patient focused innovation and contribute to a vibrant life science sector in Europe Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Clinical trials Implement the Clinical Trials Regulation 1.3-1 Deliver the required IT tools to allow implementation of the Clinical Trials Regulation 1.3-2 Update guidelines and inspectionrelated procedures in accordance with the new legal requirements 2014 2018* Critical/ urgent - availability of functional IT tools/systems 2014 2018* High - level of completion or availability of updated guidelines/processes * According to the timeframe adopted by the EMA Management Board, audit of the IT systems will take place in 2017, leading to the regulation becoming applicable by October 2018. Innovation Facilitate translating innovation into medicinal products 1.3-3 Streamline interaction with academia 2016 2019 Medium - implemented framework for collaboration with academia - increased number of interactions with academia 1.3-4 Strengthen collaboration with HTAN, EUnetHTA, HTA/pricing and reimbursement bodies to optimise the interface at market entry and to facilitate exchange between regulators 2015 2019 Medium - report on cases of divergence between MAA and a sample of HTA bodies during the reporting period - number of cases where EUnetHTA relative efficacy assessment was Work programme 2017 EMA/583016/2016 Page 20/123

Provide adequate regulatory support to innovation stemming from SMEs and academia and downstream decision makers 1.3-5 Identify areas in need of further science and innovation support for medicines development, in collaboration with the network, and communicate these to funding bodies 1.3-6 Explore opportunities to reduce regulatory and administrative burden 1.3-7 Review existing support measures and explore additional supportive measures to incentivise innovation by SMEs 1.3-8 Involve academia in early dialogue procedures (ITF, Innovation network, SA, Paediatric procedures, PRIME, orphan designation) facilitated following regulatory assessment, as part of Joint Action 3 / work package 4 Contin Contin High - number of research areas/opportunities uous uous identified 2016 2020 Medium - number of opportunities identified and implemented 2016 2020 High - increasing use of the available support measures/incentives 2016 2017 High - increase in the number of early dialogue procedures involving academia Objective 4: Strengthen regulatory capability and transparency Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Regulatory capability Strengthen pharmacovigilance capability across the network 1.4-1 Implement necessary processes to ensure capacity and capability to manage signals submitted by the pharmaceutical industry 1.4-2 Ensure EU network is ready for the new EudraVigilance functionalities, including centralised reporting and the new data format 2016 2018 High - implementation of required processes 2016 2018 High - number of NCAs/MAHs trained on new functionalities Work programme 2017 EMA/583016/2016 Page 21/123

2017 Work Programme
Work Programme 2011 - ERA - Europa
MHRA powerpoint template - TOPRA
VMGN 11 - Veterinary Medicines Directorate - Defra
IFAH-Europe annual report 2006 - Bundesverband für Tiergesundheit
How TOPRA in Spain will work - presentation
Work Programme 2013 - ECHA - Europa
final programme - digital edition - seg/esg congress 2013
The 9th TOPRA Annual Symposium 2012 - Human Medicines
Dr. Monica Vinhas de Souza - EHC
EFAMA Conference Programme
(CPD) Programme for Pharmaceutical Staff
FP7 ICT Work Programme 2013 - RTD
programme activities - European Consortium for Ocean Research ...