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Medicines for an aging population: The EMA perspective and policies.
Cerreta, Francesca; Iskra, Ewa Balkowiec; Cupelli, Amelia; Sepodes, Bruno; Rönnemaa, Elina; Rosa, Mário Miguel; Mayrhofer, Sabine; Trauffler, Martine; Torre, Carla; Berntgen, Michael; Vucic, Katarina; Bahri, Priya; Koch, Armin; Herdeiro, Maria Teresa; Mirosevic Skvrce, Nikica; Pallos, Julia; Laslop, Andrea.
Afiliación
  • Cerreta F; European Medicines Agency, Amsterdam, Noord-Holland, Netherlands.
  • Iskra EB; Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Mazowieckie, Poland.
  • Cupelli A; Medical Devices and Biocidal Products, The Office for Registration of Medicinal Products, Warsaw, Poland.
  • Sepodes B; Italian Medicines Agency, Pharmacovigilance, Rome, Italy.
  • Rönnemaa E; Faculdade de Farmácia, Universidade de Lisboa, Lisbon, Portugal.
  • Rosa MM; Lakemedelsverket, Uppsala, Sweden.
  • Mayrhofer S; Departamento de Neurociências/Laboratório de Farmacologia Clínica E Terapêutica, Universidade de Lisboa, Lisbon, Portugal.
  • Trauffler M; European and International Affairs, BfArM, Bonn, NRW, Germany.
  • Torre C; Division of Pharmacy and Medicines, Directorate of Health, Ministry of Health, Luxembourg, Strassen, Luxembourg.
  • Berntgen M; Faculdade de Farmácia, Universidade de Lisboa, Lisbon, Portugal.
  • Vucic K; Faculdade de Farmácia da Universidade de Lisboa, iMedULisboa, Lisbon, Portugal.
  • Bahri P; European Medicines Agency, Amsterdam, Noord-Holland, Netherlands.
  • Koch A; European Medicines Agency, Amsterdam, Noord-Holland, Netherlands.
  • Herdeiro MT; European Medicines Agency, Amsterdam, Noord-Holland, Netherlands.
  • Mirosevic Skvrce N; Hannover Medical School, Hannover, Niedersachsen, Germany.
  • Pallos J; Department of Medical Sciences, Institute of Biomedicine (iBiMED), University of Aveiro, Aveiro, Portugal.
  • Laslop A; HALMED, Zagreb, Croatia.
J Am Geriatr Soc ; 72(9): 2921-2927, 2024 Sep.
Article en En | MEDLINE | ID: mdl-38757979
ABSTRACT
The European Medicines Agency adopted their Geriatric Medicines Strategy more than a decade ago. The strategy aims at elucidating the evidence basis for marketing authorization of new medicines which will be used in the older population, and at ensuring the appropriate communication of findings to the patient and healthcare provider. During the past decade new tools and data sources have emerged to support the strategy goals, and their use should be considered. Possible concrete actions are presented to improve the design of clinical trials, the data collection both pre- and post-approval, the assessment of the findings, and the communication to assist informed prescription and safe medicine taking. Implementation and prioritization of these actions should be done from the perspective of addressing the needs of patients while maximizing efficient use of resources, with the aim of integrating geriatric aspects into routine medicines development and assessment.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Aprobación de Drogas Límite: Aged / Humans País/Región como asunto: Europa Idioma: En Revista: J Am Geriatr Soc Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Aprobación de Drogas Límite: Aged / Humans País/Región como asunto: Europa Idioma: En Revista: J Am Geriatr Soc Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Estados Unidos