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Work programme 2017

WC500221614

Term/abbreviation

Term/abbreviation Definition Registration of Pharmaceuticals for Human Use ICMRA International coalition of medicines regulatory authorities ICSR individual case-safety report ICT information and communication technologies IDMP Identification of Medicinal Products IGDRP International Generic Drug Regulators Programme IMI Innovative Medicines Initiative IPRF International Pharmaceutical Regulators Forum IRCH International regulatory cooperation for herbal medicines IRM Institute of Risk Management IT information technology ITF EMA Innovation Task Force ISO International Organisation for Standardisation KPI key performance indicator MA marketing authorisation MAA marketing authorisation application MAH marketing authorisation holder MAWP EMA multiannual work programme Member State (MS) Member State of the European Union MHLW Ministry of Health, Labour and Welfare, Japan MLM medical literature monitoring MNAT multinational assessment team MRL maximum residue limit MUMS minor use, minor species products NAP nationally authorised product NCA national competent authority Network European medicines regulatory network Network strategy EU Medicines Agencies Network Strategy to 2020 NTC EU Network Training Centre NUI non-urgent information OECD Organisation for Economic Cooperation and Development OIE World Organisation for Animal Health OMCL Official Medicines Control Laboratories EMA methodology for portfolio, programme and project management P3i methodology and ITIL (Information Technology Infrastructure Library, set of IT service management practices) PA protocol assistance PAES post-authorisation efficacy study Parliament European Parliament PAS Post Authorisation Studies PASS post-authorisation safety study PCO patients'/consumers' organisation PDCO Paediatric Committee PhV pharmacovigilance PIC/s Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme PIP paediatric investigation plan PMDA Pharmaceuticals and Medical Devices Agency, Japan PMF plasma master file PRAC Pharmacovigilance Risk Assessment Committee PRIME PRIority MEdicine, a scheme to foster the development of medicines with high public health potential PROTECT Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium PSUR periodic safety-update report PSUSA PSUR single assessment PUMA paediatric-use marketing authorisation Work programme 2017 EMA/583016/2016 Page 122/123

Term/abbreviation Definition Q (1, 2, 3, 4) quarter (1, 2, 3, 4) Q&A questions and answers RA rapid alert RFI request for information SA scientific advice SAG Scientific Advisory Group SAP “Systems, Applications & Products”, enterprise software to manage business operations and customer relations SAWP Scientific Advice Working Party SciCoBo Scientific Coordination Board SIAMED Sistema de Información Automatizada sobre Medicamentos (Medicines Information System) SLA service level agreement SME small and medium-sized enterprise SmPC summary of product characteristics ‘substances, products, organisations, referentials data’ project, now split SPOR into projects on ‘referentials management service’, ‘organisations management service’ and ‘substances and products management services’ STAMP EC Expert Group on Safe and Timely Access to Medicines for Patients SWP Safety Working Party Strategy EU Medicines Agencies Network Strategy to 2020 TATFAR Transatlantic Taskforce on Antimicrobial Resistance TGA Therapeutic Goods Administration, Australia UEMO European Union of General Practitioners, organisation for general practitioners and specialists in family medicine in Europe UK United Kingdom US United States of America USB USB flash drive, a data storage device VAR variance VICH International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (Web-)RADR Recognising Adverse Drug Reactions WGEO Working Group of Enforcement Officers of the HMA WHA World Health Assembly WHO World Health Organization WONCA World Organization of Family Doctors WP working party Work programme 2017 EMA/583016/2016 Page 123/123

2017 Work Programme
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Programme
WORKING