LISTA. (noiembrie 2017) AGENTIA EUROPEANA A MEDICAMENTULUI (European Medicines Agency EMA)
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1 LISTA angajaţilor ANMDM desemnaţi ca titulari sau înlocuitori în Consiliul de administraţie, comitetele ştiinţifice şi grupurile de lucru ale Agenţiei Europene a Medicamentului (EMA), ale Şefilor Agenţiilor Medicamentului, ale Directoratului European pentru Calitatea Medicamentelor (EDQM), ale Consiliului Europei, ale Consiliului Uniunii Europene, ale Schemei de Cooperare în domeniul Inspecţiilor Farmaceutice (PIC/S) şi ale Comisiei Europene (noiembrie 2017) AGENTIA EUROPEANA A MEDICAMENTULUI (European Medicines Agency EMA) 1. Consiliul de administraţie al EMA (Management Board MB): Nicolae Fotin/Alexandru Velicu 2. Comitetul pentru medicamente de uz uman (Committee for Medicinal Products for Human Use CHMP): Simona Badoi/Dana Marin 3. Comitetul de farmacovigilenţă pentru evaluarea riscului (Pharmacovigilance Risk Assessment Committee PRAC): Roxana Stroe /Nicolae Fotin 4. Comitetul pentru medicamente de uz pediatric (Paediatric Committee PDCO): Dana Marin/Simona Badoi 5. Comitetul pentru medicamente din plante (Committee for Herbal Medicinal Products HMPC): Carmen Purdel/Raluca Iavorszky 5 a. Grupul de lucru pentru monografii si liste al Comitetului pentru medicamente din plante (Monograph and List Working Party): Carmen Purdel 6. Comitetul pentru medicamente orfane (Committee for Orphan Medicinal Products COMP): Olimpia Neagu 7. Comitetul pentru terapii avansate (Committee for Advanced Therapies): Simona Bădoi/Gianina Andrei 8. Grupul de lucru al CHMP pentru produse biologice (CHMP Biologics Working Party): Mirela Tavakol/Gianina Andrei 9. Grupul de lucru al CHMP pentru siguranţă (CHMP Safety Working Party): Violeta Tămăşdan/Petre Cojocaru 1
2 10. Grupul de lucru al CHMP pentru produse din sânge (CHMP Blood Products Working Party): Cristiana Ilie/Mirela Tavakol 11. Grupul de lucru al CHMP pentru vaccinuri (CHMP Vaccines Working Party): Mirela Tavakol 12. Grupul de lucru comun CHMP/CVMP pe probleme de calitate (Joint CHMP/CVMP Quality Working Party): Daniela Nicolescu/Ştefania Simionescu 13. Grupul de lucru pentru inspectorii GMP/GDP (GMP/GDP Inspectors Working Group): Victoriţa Ivaşcu/Gabriela Ruja + Cringuta Braiescu 14. Subgrupul de lucru pentru baza de date EudraGMP (EudraGMP Database Sub working Group): Crînguţa Brăiescu/Ani Stoica 15. Grupul de lucru pentru inspectorii GCP (GCP Inspectors Working Group): Adina Pîrvu 16. Grupul de lucru pentru inspectorii GLP (GLP Inspectors Working Group): Mihaela Sebe/Mihaela Stroeşteanu 17. Grupul de lucru pentru inspectorii de farmacovigilenţă (Pharmacovigilance inspectors Working Group): Mihaela Sebe/Mihaela Stroeşteanu 18. Grupul de lucru pentru termenii controlaţi (European Union Telematics Controlled Terms EUTCT): Sorin Timofei+Gabriela Baciu 19. Grupul de lucru pentru verificarea calităţii traducerii informaţiilor privind medicamentul (Working Group on Quality Review of Documents QRD): Adina Preda/Denisse Mazilu 20. Grupul de lucru pentru revizuirea denumirilor inventate (Invented Name Review Group NRG): Marina Popescu/Denisse Mazilu 21. Grupul de lucru al Directorilor IT (IT Directors Group): Sorin Timofei/Florin Stanciu 22. Portalul și baza de date UE pentru studii clinice (the EU Clinical Trial Portal and Database): Mirela Vîţă/Victor Cojocaru 2
3 ŞEFII AGENŢIILOR MEDICAMENTULUI (Heads of Agencies HMA) 23. Întâlnirile Şefilor Agenţiilor Medicamentului (Heads of Medicines Agencies HMA): Nicolae Fotin 24. Grupul de coordonare a procedurii de recunoaştere mutuală şi a procedurii descentralizate pentru medicamente de uz uman (Co ordination Group for Mutual Recognition and Decentralised Procedures Human CMDh): Ada Georgescu/Marina Popescu 25. Grupul de lucru pentru legislaţie (EMACOLEX European Medicines Agencies Cooperation on Legal and Legislative issues): Silvia Albăstroiu/Cristina Gavrilă+Nicolae Fotin 26. Grupul de lucru al profesioniştilor în domeniul comunicării (Communication Professionals Working Group): Anca Crupariu 27. Grupul de lucru pentru aplicarea legislaţiei/combaterea falsificării medicamentelor (Working Group of Enforcement Officers WGEO): Crînguţa Brăiescu/Sorin Timofei + Silvia Albăstroiu 28. Grupul de lucru pentru medicamente homeopate (Homeopathic Medicinal Products Working Party HMPWG): Raluca Iavorszky/Gheorghe Murguleț 29. Grupul de lucru al managerilor de calitate (Quality Managers HMA Working Group): Nicolae Fotin/Gabriela Corbeanu 30. Grupul de lucru pentru facilitarea studiilor clinice (Clinical Trials Facilitation Group): Mirela Vîţă/Victor Cojocaru ŞEFII AGENŢIILOR MEDICAMENTULUI AGENTIA EUROPEANA A MEDICAMENTULUI 31. Grupul de lucru pentru Dosarul Standard al Substanței Active (Active Substance Master File Working Group): Ada Georgescu/Marina Popescu DIRECTORATUL EUROPEAN PENTRU CALITATEA MEDICAMENTULUI (European Directorate for the Quality of Medicines EDQM) 32. Reţeaua Laboratoarelor Oficiale pentru Controlul Medicamentelor (Official Medicines Control Laboratories OMCL): Denisa Petrescu, Andreea Toma, Maria Magdalena Roşu, Gabriela Corbeanu, Mirela Tavakol, Gianina Andrei 3
4 33. Comisia Farmacopeii Europene (European Pharmacopoeia Commission): Anca Crupariu 34. Întâlnirea anuală a reprezentanţilor Farmacopeilor naţionale din ţările membre ale «Convenţiei pentru elaborarea Farmacopeii Europene» şi nominalizaţi ca membri ai Comisiei Farmacopeii Europene: Anca Crupariu CONSILIUL EUROPEI (the Council of Europe) 35. Grupul de lucru pentru Clasificarea pentru eliberare a medicamentelor al Consiliului Europei (Committee of Experts on the Classification of Medicines as Regards their Supply CD P PH/PHO): Denisse Mazilu CONSILIUL UNIUNII EUROPENE (Council of the European Union) 36. Grupul de lucru privind Medicamentele şi Dispozitivele Medicale al Consiliului Uniunii Europene (Working Group on Medicinal Products and Medical Devices of the EU Council): Vîţă a) pentru medicamentul de uz uman: Nicolae Fotin/Simona Bădoi/Mirela b) pentru dispozitive medicale: Margareta Mihalache/Ioana Ţene/Marilena Priboianu CONVENȚIA PENTRU INSPECȚIE FARMACEUTICĂ/SCHEMA DE COOPERARE PENTRU INSPECȚIE FARMACEUTICĂ (Pharmaceutical Inspection Convention PIC/Pharmaceutical Inspection Co operation Scheme PIC/S) 37. Comitetul oficialilor (PIC/S Committee of Officials): Victoriţa Ivaşcu/Mihaela Sebe/Gabriela Ruja COMISIA EUROPEANĂ (the European Commission) 38. Comitetul permanent pentru medicamente de uz uman (Standing Committee on Medicinal Products for Human Use): Marius Tanasă/Nela Vîlceanu 39. Comitetul Farmaceutic (Pharmaceutical Committee): Nela Vîlceanu 40. Recomandări pentru solicitanţi (Notice to Applicants): Ada Georgescu/Gabriela Baciu 41. Grupul de experți cu privire la studiile clinice (Expert Group on Clinical Trials): Mirela Vîţă/Victor Cojocaru 4
5 42. Grupul de lucru Ad hoc pentru exceptarea de la prevederile Regulamentului (UE) nr. 1394/2007 al Parlamentului European și al Comisiei cu privire la medicamentele pentru terapii avansate: Simona Badoi 43. Grupul de lucru pentru experții în dispozitive medicale (Medical Devices Expert Group MDEG): Ioana Ţene/Margareta Mihalache/Marilena Priboianu. 44. Grupul experților pentru Vigilență în domeniul Dispozitivelor Medicale (Medical Device Vigilance Experts Group): Marilena Priboianu/Margareta Mihalache 45. Grupul de lucru pentru Clasificare şi Dispozitive Medicale la Graniță (Classification and Borderline Work Group): Margareta Mihalache/Ioana Ţene 46. Grupul pentru Conformitate şi Aplicare (Compliance and Enforcement Group COEN): Ioana Ţene/Marilena Priboianu 47. Grupul pentru coordonarea Organismelor Notificate (Notified Body Operational Group NBOG): Ioana Ţene 48. Grupul tehnic pentru Dispozitive Medicale pentru Diagnostic In Vitro (IVD Technical Group): Cristina Durle 49. Grupul de lucru pentru Investigații şi Evaluări Clinice (Working Group on Clinical Investigation and Evaluation CIE): Margareta Mihalache/Oana Arsenescu 50. Grupul de lucru pentru Etichetare Electronică (Electronic Labelling Working Group): Marilena Priboianu/Oana Arsenescu 51. Grupul de lucru pentru tehnologii noi şi în curs de dezvoltare (New & Emerging Technologies Working Group NET): Margareta Mihalache/Oana Arsenescu 52. Grupul de lucru pentru Eudamed (Eudamed Working Group): Margareta Mihalache/Marilena Priboianu 5
6 53. Grupul de lucru pentru Organisme Notificate (NB MED): Ioana Ţene/Margareta Mihalache 54. Grupul de lucru pentru Identificarea Unică a Dispozitivelor (UDI Working Group): Marilena Priboianu/Margareta Mihalache 6
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