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Work programme 2017

WC500221614

Address the threat posed

Address the threat posed by illegal medicines supply chains Facilitate/support availability of already approved medicines 1.1-15 Consolidate information on compliance issues and quality defects 1.1-16 Continue to support the implementation of the Falsified Medicines Directive 1.1-17 Streamline process for reporting of suspected falsified medicines in the supply chain by MAHs 1.1-18 Strengthen communication within the network, including with WGEO 1.1-19 Review collaboration with EDQM in the framework of the sampling and testing programme to include increased number of APIs and parallel distribution medicinal products 1.1-20 Support and contribute to Member States' efforts in addressing issues that limit access to already authorised medicines highly enriched uranium to low enriched uranium in the production of radiopharmaceuticals 2017 2019 Medium - system of warning letters in case of GMP non-compliance issues implemented - improvements implemented in the coordination/handling of quality defects across the network 2011 2019 High - number of cases supported/coordinated by EMA in relation to falsified medicines in the supply chain 2011 2019 High - implementation of the revised form for reporting quality defects and suspected falsified medicines 2014 2019 High - timely sharing of relevant information related to illegal supply chain as it is notified to EMA 2016 2018 High - criteria for inclusion of APIs and parallel distribution medicinal products in the sampling and testing programme agreed and reflected in new contract with EDQM 2016 2020 Medium To be confirmed, based on the reflection paper (to be finalised in 2016) Work programme 2017 EMA/583016/2016 Page 18/123

Objective 2: Ensure timely access to new beneficial and safe medicines for patients Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Reduce time–to-patient of novel 1.2-1 Integrate 'adaptive pathways' concept 2014 2018 Medium - number of development proposals medicines through optimised into formal EMA scientific advice following the adaptive pathways concept use of existing and new assessment approaches within procedures in scientific advice existing regulatory frameworks 1.2-2 Provide reinforced regulatory and 2014 2017 Critical/ - number/increase in PRIME products scientific advice for priority medicines urgent that received scientific advice (PRIME) - time from request to final response – compared with other products and with previous period 1.2-3 Develop/enhance collaboration with EUnetHTA, HTAN as well as 2010 2019 High - number of procedures for parallel scientific advice HTA/pricing and reimbursement bodies - number of HTA bodies involved in the area of parallel regulatory-HTA scientific advice, including contribution - analysis on scientific views expressed by regulators and HTA bodies, to specific deliverables in EUnetHTA respectively, on development Early access to medicines Support effective and efficient conduct of pharmacovigilance Joint Action 3 1.2-4 Implement planned access and analysis of real-world data 1.2-5 Conduct planned surveillance using patient registries, also in collaboration with EUnetHTA Joint Action 3 programmes - deliverables of Joint Action 3 / work package 5a with regard to parallel regulatory-HTA scientific advice 2016 2020 High - availability and use of tools and processes for analysing real-world data 2016 2019 High - patient registries actually used for novel medicines Work programme 2017 EMA/583016/2016 Page 19/123

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