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1.
Strengthening the Interface of Evidence-Based Decision Making Across European Regulators and Health Technology Assessment Bodies.
Value Health
; 25(10): 1726-1735, 2022 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-35370077
2.
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.
Br J Clin Pharmacol
; 86(6): 1034-1051, 2020 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-32162368
3.
Improving the contribution of regulatory assessment reports to health technology assessments--a collaboration between the European Medicines Agency and the European network for Health Technology Assessment.
Value Health
; 17(5): 634-41, 2014 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-25128058
4.
Medicines for an aging population: The EMA perspective and policies.
J Am Geriatr Soc
; 2024 May 17.
Artículo
en Inglés
| MEDLINE | ID: mdl-38757979
5.
An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators.
J Mark Access Health Policy
; 12(1): 21-34, 2024 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-38544972
6.
Inclusion of functional measures and frailty in the development and evaluation of medicines for older adults.
Lancet Healthy Longev
; 4(12): e724-e729, 2023 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-37977177
7.
The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy's multi-stakeholder pre-convention questionnaire.
J Mark Access Health Policy
; 11(1): 2217543, 2023.
Artículo
en Inglés
| MEDLINE | ID: mdl-37284060
8.
Paediatric Strategy Forum for medicinal product development of chimeric antigen receptor T-cells in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Eur J Cancer
; 160: 112-133, 2022 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34840026
9.
Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.
Clin Pharmacol Ther
; 104(3): 539-545, 2018 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-29319156
10.
Digital technologies for medicines: shaping a framework for success.
Nat Rev Drug Discov
; 19(9): 573-574, 2020 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-32398879
11.
Linaclotide for treatment of irritable bowel syndrome--the view of European regulators.
Dig Liver Dis
; 45(9): 724-6, 2013 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-23701993
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