Výsledky vyhledávání - "Regulatory Affairs"

IntroductionThis study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care.MethodsThrough qualitative research, we sought expert insights to understand the fac

Externí odkaz: https://doaj.org/article/4a2d7e079cb949719542d73f4965f349

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Akademický článek

Currently practising regulatory affairs pharmacists-were they ready to practice at the time of graduation - An exploratory cross-section study

Autor: Khraim, Abeer ^a, Alabbadi, Ibrahim ^a, Alnahar, Saja A. ^{b, c, ⁎}

Publikováno v: In Currents in Pharmacy Teaching and Learning March 2025 17(3)

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Akademický článek

Polish regulatory system regarding ATMP hospital exemptions

Autor: Jan Pachocki, Frances Verter

Publikováno v: Frontiers in Immunology, Vol 15 (2024)

IntroductionThis article explains the current regulatory system in Poland regarding Advanced Therapy Medicinal Products given under Hospital Exemptions (ATMP-HE).MethodsThe relevant sections of Polish legislation are translated into English and their

Externí odkaz: https://doaj.org/article/6ec5b90b574347cc8361c85d11a73de2

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Regional administrative data and their role in planning, programming and controlling at regional level

Autor: Irene Marzona, Paolo Stella, Gianluca Trifirò, Giovanni Corrao

Publikováno v: Global & Regional Health Technology Assessment, Vol 11, Iss 1 (2024)

Regional administrative data may help public administrations in organizing their information, identifying problems, defining solutions and verifying results of the actions taken. The objective of this work is to present the discussion output of the

Externí odkaz: https://doaj.org/article/97c1b63f82ad45b1987d6898910611ce

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Akademický článek

Randomized Registry Trials - efficient post market clinical follow-up for medical devices

Autor: Leuchter Matthias, Siewert Stefan, Stiehm Michael, Klar Ernst, Schmitz Klaus-Peter, Kaule Sebastian

Publikováno v: Current Directions in Biomedical Engineering, Vol 9, Iss 1, Pp 487-490 (2023)

In spite of advances in the treatment of cardiovascular disease, there remains a significant need for high-quality evidence for clinical practice given the rising prevalence worldwide. Next to the increase of regulatory requirements, poor screening-t

Externí odkaz: https://doaj.org/article/c551dce07b064e928b6ab4100ec6418e

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