Detalhe da pesquisa
1.
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.
Artigo
em Inglês
| MEDLINE | ID: mdl-32162368
2.
The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries.
BioDrugs
; 37(2): 235-245, 2023 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-36472773
3.
Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future-An Industry View.
Ther Innov Regul Sci
; 57(5): 940-951, 2023 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-37266868
4.
Role of innovation in pharmaceutical regulation: A proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective.
Drug Discov Today
; 28(5): 103526, 2023 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-36792005
5.
Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers.
Ther Innov Regul Sci
; 57(6): 1199-1208, 2023 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-37460826
6.
Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?
Ther Innov Regul Sci
; 56(2): 366-377, 2022 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-35129827
7.
The ASAP Framework: A New Tool for Regulatory Agencies to Facilitate Adoption of Pandemic Approaches.
Health Secur
; 22(3): 249-262, 2024 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-38624265