المؤلفون: Mariia V. Maksimova, Ghislaine J. M. W. van Thiel, Yke Tromp, Rosan Lechner, Johannes J. M. van Delden, Lourens T. Bloem

المصدر: Frontiers in Medicine, Vol 11 (2024)

مصطلحات موضوعية: conditional marketing authorization, research ethics, clinical ethics, expedited regulatory pathways, unmet medical need, uncertainty, Medicine (General), R5-920

وصف الملف: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fmed.2024.1408553/full; https://doaj.org/toc/2296-858X

URL الوصول: https://doaj.org/article/07f3fa560b54482783616b74dd73c243

المؤلفون: Andrade, Ana Sofia Borges Rocha de

المساهمون: Torre, Carla Alexandra de Matos, Repositório da Universidade de Lisboa

مصطلحات موضوعية: Conditional marketing authorization, Post-authorization studies, EU PAS register, Pharmaceutical regulation, European Medicines Agency, Risk management plan, Specific obligation, Mestrado Integrado - 2023, Domínio/Área Científica::Ciências Médicas::Ciências da Saúde

وصف الملف: application/pdf

الاتاحة: http://hdl.handle.net/10451/64453

المؤلفون: Maksimova, Mariia V., van Thiel, Ghislaine J.M.W., Tromp, Yke, Lechner, Rosan, van Delden, Johannes J.M., Bloem, Lourens T.

المساهمون: Medical Humanities Onderzoek Team 1, JC onderzoeksprogramma Methodology, Regenerative Medicine and Stem Cells

مصطلحات موضوعية: clinical ethics, conditional marketing authorization, European Medicines Agency, expedited regulatory pathways, informed consent, research ethics, uncertainty, unmet medical need, General Medicine

وصف الملف: application/pdf

Relation: https://dspace.library.uu.nl/handle/1874/454405

الاتاحة: https://dspace.library.uu.nl/handle/1874/454405

المؤلفون: Bloem, Lourens T, Bot, Rosalinde E, Mantel-Teeuwisse, Aukje K, van der Elst, Menno E, Sonke, Gabe S, Klungel, Olaf H, Leufkens, Hubert G M, Hoekman, Jarno

المساهمون: Afd Pharmacoepi & Clinical Pharmacology, Dep Farmaceutische wetenschappen, Innovation and Sustainability, Pharmacoepidemiology and Clinical Pharmacology, Innovation Studies, PECP – Centre for Clinical Therapeutics, PECP - Centre for Pharmacoepidemiology, PECP - Centre for Pharmaceutical Policy and Regulation

مصطلحات موضوعية: European Medicines Agency, benefit–risk assessment, clinical benefit, clinical trials, conditional marketing authorization, drug regulation, Pharmacology (medical), Pharmacology

وصف الملف: application/pdf

Relation: https://dspace.library.uu.nl/handle/1874/425060

الاتاحة: https://dspace.library.uu.nl/handle/1874/425060

المؤلفون: Naesens, Maarten, Budde, Klemens, Hilbrands, Luuk, Oberbauer, Rainer, Bellini, Maria Irene, Glotz, Denis, Grinyó, Josep, Heemann, Uwe, Jochmans, Ina, Pengel, Liset, Reinders, Marlies, Schneeberger, Stefan, Loupy, Alexandre

المساهمون: Naesens, Maarten, Budde, Klemen, Hilbrands, Luuk, Oberbauer, Rainer, Bellini, Maria Irene, Glotz, Deni, Grinyó, Josep, Heemann, Uwe, Jochmans, Ina, Pengel, Liset, Reinders, Marlie, Schneeberger, Stefan, Loupy, Alexandre

مصطلحات موضوعية: rejection, outcome, graft function, conditional marketing authorization, iBox

Relation: info:eu-repo/semantics/altIdentifier/pmid/35669974; info:eu-repo/semantics/altIdentifier/wos/WOS:000822711200001; volume:35; numberofpages:14; journal:TRANSPLANT INTERNATIONAL; https://hdl.handle.net/11573/1639358; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85131339298

الاتاحة: https://hdl.handle.net/11573/1639358
https://doi.org/10.3389/ti.2022.10136

المؤلفون: Bloem, Lourens T, Bot, Rosa E, Mantel-Teeuwisse, Aukje K, van der Elst, Menno E, Sonke, Gabe S, Klungel, Olaf H, Leufkens, Hubert G M, Hoekman, Jarno

المصدر: Bloem , L T , Bot , R E , Mantel-Teeuwisse , A K , van der Elst , M E , Sonke , G S , Klungel , O H , Leufkens , H G M & Hoekman , J 2022 , ' Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe : A comparison with standard approved cancer drugs ' , British Journal of Clinical Pharmacology , vol. 88 , no. 5 , pp. 2169-2179 . https://doi.org/10.1111/bcp.15141

مصطلحات موضوعية: European Medicines Agency, benefit–risk assessment, clinical benefit, clinical trials, conditional marketing authorization, drug regulation, Europe, Humans, Antineoplastic Agents/therapeutic use, Neoplasms/drug therapy, Drug Approval, Quality of Life, Prior Authorization

وصف الملف: application/pdf

Relation: https://portal.findresearcher.sdu.dk/da/publications/4d414cd8-4044-4674-8f18-3b02829e82b8

الاتاحة: https://portal.findresearcher.sdu.dk/da/publications/4d414cd8-4044-4674-8f18-3b02829e82b8
https://doi.org/10.1111/bcp.15141
https://findresearcher.sdu.dk/ws/files/203518127/Brit_J_Clinical_Pharma_2021_Bloem_Pre_approval_and_post_approval_availability_of_evidence_and_clinical_benefit_of.pdf

المؤلفون: Getova, Violeta, Getov, Ilko

المصدر: Годишник по болнична фармация; Vol 7, No 1 (2021); 13-19 ; Annual for Hospital Pharmacy; Vol 7, No 1 (2021); 13-19 ; 2603-3852 ; 2367-8763

مصطلحات موضوعية: drug regulation, marketing authorization, conditional marketing authorization, benefit/risk ratio

وصف الملف: application/pdf

Relation: https://journals.mu-varna.bg/index.php/ahp/article/view/8068/7145; https://journals.mu-varna.bg/index.php/ahp/article/view/8068

الاتاحة: https://journals.mu-varna.bg/index.php/ahp/article/view/8068
https://doi.org/10.14748/ahp.v7i1.8068

المؤلفون: Andrade, Ana Sofia Borges Rocha de

المساهمون: Torre, Carla Alexandra de Matos

مصطلحات موضوعية: Conditional marketing authorization, Post-authorization studies, EU PAS register, Pharmaceutical regulation, European Medicines Agency, Risk management plan, Specific obligation, Mestrado Integrado - 2023, Domínio/Área Científica::Ciências Médicas::Ciências da Saúde

Relation: http://hdl.handle.net/10451/64453; 203512049

الاتاحة: http://hdl.handle.net/10451/64453

المؤلفون: Vreman, Rick A., Mantel-Teeuwisse, Aukje K., Hövels, Anke M., Leufkens, Hubert G.M., Goettsch, Wim G.

المساهمون: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmaceutical Policy and Regulation

مصطلحات موضوعية: conditional marketing authorization, cost-effectiveness assessment, differences, evidence, health technology assessment, practice, procedure, process, regulation, reimbursement, relative-effectiveness assessment, Health Policy, Public Health, Environmental and Occupational Health

وصف الملف: application/pdf

Relation: https://dspace.library.uu.nl/handle/1874/410897

الاتاحة: https://dspace.library.uu.nl/handle/1874/410897

المؤلفون: Vreman, Rick A., Belitser, Svetlana V., Mota, Ana T.M., Hövels, Anke M., Goettsch, Wim G., Roes, Kit C.B., Leufkens, Hubert G.M., Mantel-Teeuwisse, Aukje K.

المساهمون: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, PECP - Centre for Pharmaceutical Policy and Regulation

مصطلحات موضوعية: clinical trials, conditional marketing authorization, efficacy, oncology, phase, regulation, Pharmacology, Pharmacology (medical)

وصف الملف: application/pdf

Relation: https://dspace.library.uu.nl/handle/1874/410894

الاتاحة: https://dspace.library.uu.nl/handle/1874/410894

المؤلفون: Marjolein Garsen, Maaike Steenhof, Alex Zwiers

المصدر: Therapeutic Innovation & Regulatory Science

مصطلحات موضوعية: Antineoplastic Agents, Drug development, Pharmacy, Marketing authorization, Orphan drug, 03 medical and health sciences, 0302 clinical medicine, EMA, Agency (sociology), Global health, Humans, media_common.cataloged_instance, Pharmacology (medical), Operations management, European Union, Conditional marketing authorization, European union, Drug Approval, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), Original Research, Cancer, 030304 developmental biology, media_common, Marketing, 0303 health sciences, Accelerated assessment, business.industry, Public Health, Environmental and Occupational Health, Authorization, Timeline, Scientific advice, 030220 oncology & carcinogenesis, business

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d247d3b2f02386fdb5219af293b7dd59
https://doi.org/10.1007/s43441-021-00260-5

المؤلفون: Odile Launay, Rafael Dal-Ré

المصدر: Vaccine

مصطلحات موضوعية: 2019-20 coronavirus outbreak, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Public administration, Trust, Elderly, EMA, Agency (sociology), Drug approval, Humans, Medicine, Conditional marketing authorization, Drug Approval, General Veterinary, General Immunology and Microbiology, SARS-CoV-2, business.industry, Public Health, Environmental and Occupational Health, COVID-19, AstraZeneca vaccine, Europe, Vaccine label, Infectious Diseases, Older adults, Commentary, Public trust, Molecular Medicine, business

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e089affd14af5476434dc443dd33e13f
https://doi.org/10.1016/j.vaccine.2021.05.095

المؤلفون: Rafael Dal-Ré

المصدر: Journal of Clinical Epidemiology

مصطلحات موضوعية: medicine.medical_specialty, Emergency Use Authorization, 2019-20 coronavirus outbreak, conditional marketing authorization, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), Epidemiology, business.industry, SARS-CoV-2, withdrawal, emergency use authorization, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19, vaccines, Placebo, Risk Assessment, Article, Placebos, Research Design, Internal medicine, medicine, Humans, placebo-controlled trials, business, Randomized Controlled Trials as Topic

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::90aec091afff501a48bc4a08add37570
http://europepmc.org/articles/PMC8276569

المؤلفون: Maksimova, Mariia V, van Thiel, Ghislaine J M W, Tromp, Yke, Lechner, Rosan, van Delden, Johannes J M, Bloem, Lourens T

المصدر: Frontiers in Medicine vol.11 (2024) date: 2024-06-23 [ISSN 2296-858X]

مصطلحات الفهرس: European Medicines Agency, clinical ethics, conditional marketing authorization, expedited regulatory pathways, informed consent, research ethics, uncertainty, unmet medical need, Article

URL: https://research-portal.uu.nl/en/publications/70820495-62be-4e02-838a-ed78fb6fde3f
https://research-portal.uu.nl/ws/files/232540384/fmed-11-1408553.pdf
https://research-portal.uu.nl/ws/files/232540384/fmed-11-1408553.pdf

المؤلفون: Hattem, Christine van, Bloem, Lourens (Thesis Advisor)

مصطلحات الفهرس: For anticancer medicines that have been granted conditional marketing authorization based on incomprehensive evidence from single-arm trial data, randomized controlled trials (RCTs) are requested after CMA to generate comprehensive evidence. In this study, we explored conditions that affect the feasibility of such post-authorization RCTs, from a multistakeholder perspective., Master Thesis, Student Thesis

URL: https://studenttheses.uu.nl/handle/20.500.12932/46123

المؤلفون: Jagoui, Narjisse, Bloem, Lourens (Thesis Advisor)

مصطلحات الفهرس: The aim of this study was to investigate the follow-up of specific obligations required for anticancer medicinal products granted a conditional marketing authorization, including their duration, potential changes, and reasons for these changes., Master Thesis, Student Thesis

URL: https://studenttheses.uu.nl/handle/20.500.12932/45704