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Work programme 2017

WC500221614

Area Medium-term

Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) approaches to best use of existing and resistance developed and published new antiparasitic veterinary medicine so as to minimise development of anthelmintic resistance Promote innovation and use of 2.1-5 Evaluate the impact of measures 2016 2019 High - increasing number of applications in new approaches in the recently put in place to support novel therapies development of veterinary medicines innovation (ADVENT, ITF) and implement improvements in measures - report on impact of measures to promote innovation published to support innovation 2.1-6 Develop and implement regulatory 2015 2019 High - increased number of applications for guidance in priority areas for technologies that are new to veterinary innovative medicines - guidance on areas of cell-based medicine therapies and monoclonal antibodies Innovation published - gap analysis on regulatory approaches to facilitate authorisation of alternatives to antimicrobials completed Ensure the establishment of MRLs supports the safe use of 2.1-7 Review the approach on genotoxic impurities in veterinary medicinal 2014 2016 High - first draft of guideline on genotoxic impurities in veterinary medicines veterinary medicines in regard products published Maximum residue limits to their impact on human health 2.1-8 Finalise, in collaboration with ECHA and EC, the procedure for the establishment of MRLs for biocidal substances used in animal husbandry included in the 10-year review programme (long-used substances) 2.1-9 Provide technical support to the European Commission in drafting 2015 2017 High - role of EMA confirmed with the European Commission for establishment of MRLs for biocidal substances 2016 2017 High - recommendations and implementing acts sent to the EC Work programme 2017 EMA/583016/2016 Page 24/123

implementing acts specified in Regulation 470/2009 Objective 2: Promote 'Better Regulation' Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Legislative framework Plan for and implement the revised veterinary legislation 2.2-1 Provide necessary advice to the European Commission during the codecision process for the new veterinary legislation 2.2-2 Put in place the revised processes and IT systems envisaged in the revised legislation 2014 2019 High - advice provided to the European Commission on request in a timely and accurate manner 2015 2019 Critical/ - IT systems and processes implemented urgent - practical approaches to harmonisation of the SmPCs of veterinary medicinal products developed with the Network Support efficient and effective 2.2-3 Publish information to the general 2016 2020 High - annual pharmacovigilance bulletin conduct of pharmacovigilance public on the surveillance of centrally published authorised veterinary products on the market 2.2-4 Strengthen signal-detection for 2016 2019 High - data on nationally authorised products Veterinary pharmacovigilance veterinary medicines by developing an approach for ensuring quality control and verification of product data in the EU database of veterinary medicines, and linking these data to adverse event information in the EudraVigilance veterinary data warehouse 2.2-5 Revise the reflection paper on promoting pharmacovigilance reporting supplied for use in EudraVigilance - data quality controlled and linked to adverse event information in the data warehouse - approach defined to develop and deliver a replacement database for EVVet 2 - VICH-compliant database fully operational 2016 2017 Low - increase in reporting of adverse reactions in food-producing species, Work programme 2017 EMA/583016/2016 Page 25/123

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