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Work programme 2017

WC500221614

Annex 7: Terms and

Annex 7: Terms and abbreviations Term/abbreviation 3Rs AD ADAPT SMART ADR ADVANCE ADVENT AE AER Agency AMR API Art AST AST/SC ATD ATMP BEMA CAP CAT CCTV CESP CHMP CHMP ORGAM CMDh CMDv CO 2 CoI Commission committee(s) COMP Council CVMP CxMP (DG) DIGIT DoI DPO eAF eCV EC ECD ECHA eCTD ECDC EDPS EDQM EEA EFPC EFSA EFTA Definition '3 R' principles in testing of medicines for regulatory purposes: replacement, reduction and refinement administrator category post Accelerated development of appropriate patient therapies: a sustainable, multi-stakeholder approach from research to treatment-outcomes; a European public-private collaboration adverse drug reaction Accelerated development of vaccine benefit-risk collaboration in Europe project ad hoc expert group on veterinary novel therapies adverse event adverse event report European Medicines Agency antimicrobial resistance active pharmaceutical ingredient article assistant category post secretarial and clerical category post access to documents advanced-therapy medicinal product benchmarking of European medicines agencies centrally authorised product Committee for Advanced Therapies closed-circuit television, video surveillance system Common European eSubmission Platform Committee for Medicinal Products for Human Use virtual meeting held to discuss CHMP organisational matters Coordination Group for Mutual Recognition and Decentralised Procedures - Human Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary carbon dioxide conflict of interest European Commission scientific committee(s) of the Agency Committee for Orphan Medicinal Products European Council Committee for Medicinal Products for Veterinary Use scientific committee(s) of the Agency European Commission’s department for informatics declaration of interests data protection officer electronic application form electronic Curriculum Vitae European Commission Eudra Common Directory European Chemicals Agency electronic common technical document European Centre for Disease Prevention and Control European data protection supervisor European Directorate for the Quality of Medicines and Healthcare European Economic Area European Forum for Primary Care European Food Safety Authority European Free Trade Association Work programme 2017 EMA/583016/2016 Page 120/123

Term/abbreviation Definition EMA European Medicines Agency EMAS EU Eco-Management and Audit Scheme ENCePP European Network of Centres for Pharmacoepidemiology and Pharmacovigilance EPAR European public assessment report EPITT European Pharmacovigilance Issues Tracking Tool eRMR electronic reaction monitoring report ESVAC European Surveillance of Veterinary Antimicrobial Consumption EU European Union EudraCT European Union Drug Regulating Authorities Clinical Trials EudraGMDP European Union Drug Regulating Authorities good manufacturing and distribution practice EudraLink European Union Drug Regulating Authorities secure file sharing EudraMail European Union Drug Regulating Authorities email services EudraNet European Union Drug Regulating Authorities secure Network for the EU regulatory network EudraPharm European Union Drug Regulating Authorities Pharmaceutical Database EudraVigilance European Union Drug Regulating Authorities Pharmacovigilance EUnetHTA European network for health technology assessment EU reference dates, list of active substances and combinations of active EURD list substances contained in medicinal products subject to different marketing authorisations, together with the corresponding EU reference dates, frequencies for submission of PSURs and related data lock points EUTCT EU Controlled Terminology EV EudraVigilance, European Union Drug Regulating Authorities Pharmacovigilance EVVet EudraVigilance, European Union Drug Regulating Authorities Pharmacovigilance - veterinary EXB EMA Executive Board FDA United States Food and Drug Administration FG (I, II, III, IV) function group (for contract agent staff) FP-7 7 th Framework programme, EU research and innovation funding programme for 2007-2013 FTE full-time equivalent Group of Eight – group of eight highly industrialized nations – France, G8 Germany, Italy, the United Kingdom, Japan, the United States, Canada, and Russia GAAD Global Action Against Dementia GCP good clinical practice GL guideline GLP good laboratory practice GMP good manufacturing practice GMDP good manufacturing and distribution practice GMDP IWG good manufacturing and distribution practice inspectors working group GP general practitioner GVP good pharmacovigilance practice GxP good practice (clinical, laboratory, manufacturing, distribution, pharmacovigilance etc) HCIN Heads of Communication and Information Network (of EU agencies) HCP healthcare professional HL7 Health Level 7 HMA Heads of Medicines Agencies Horizon 2020 EU framework programme for research and innovation for 2014-2020 HR Human Resources HMPC Committee on Herbal Medicinal Products HTA health technology assessment HTAN Health Technology Assessment Network ICH International Council for Harmonisation of Technical Requirements for Work programme 2017 EMA/583016/2016 Page 121/123

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