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The complexity of developing and applying increasingly sophisticated new medicinal products has led to the participation of many non-medically qualified scientists in multi-disciplinary non-clinical and clinical drug development teams world-wide. In this introductory paper to the "IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists" it is argued that all members of such multidisciplinary teams must share the scientific and ethical responsibilities since they all influence directly or indirectly both the outcome of the various phases of the medicines development projects and the safety of the research subjects involved. The participating medical practitioner retains the overriding responsibility and the final decision to stop a trial if the well-being of the research subjects is seriously endangered. All the team members should follow the main ethical principles governing human research, the respect for autonomy, justice, beneficence and non-maleficence. Nevertheless, the weighing of these principles might be different under various conditions according to the specialty of the members.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6130227 | PMC |
http://dx.doi.org/10.3389/fphar.2018.00843 | DOI Listing |
Int J Integr Care
July 2025
Endowed professor of Organisation and Policy in Long-term Care (em.), Department of Organization Sciences, VU University Amsterdam, The Netherlands.
Introduction: This study aims to identify success factors and challenges of an integrated care model, with an underlying goal of addressing the labor shortage in dementia care. The research investigates the interdisciplinary communication in a long-term care facility in Amsterdam, focusing on the collaboration between the so-called 'Happymakers' (non-medically trained staff) and qualified personnel. The Relational Coordination Theory serves as theoretical framework, emphasizing the need for shared goals, knowledge, and mutual respect for effective communication.
View Article and Find Full Text PDFPharmaceut Med
July 2025
PharmaTrain Federation, Brussels, Belgium.
Pharmaceutical Medicine (PM) was defined by its founding pharmaceutical physicians as a "medical/scientific discipline concerned with the discovery, development, evaluation, registration, monitoring, and medical aspects of the commercialization of medicines, for the benefit and the health of the community." Conceived as a medical specialty, the discipline encompassed several health-related professions and occupations, such as medicine, pharmacy, clinical pharmacology, drug safety and pharmacovigilance, pharmaceutical sciences, biology, health economics and others. Historically, non-medically qualified medicines development scientists from health-related disciplines have gradually grown into the medical roles within pharmaceutical organizations, regulatory agencies, and contract research organizations and today physicians and non-physicians lead drug development groups.
View Article and Find Full Text PDFPharmaceut Med
July 2025
The Academy of Global Medicines Development Professionals (GMDP Academy), New York, NY, USA.
Medicines development has dramatically transformed in the preceding decades. It has evolved from a task undertaken by a small team to a complex series of activities, involving several functions and qualified professionals, across multiple, interrelated, scientific disciplines, worldwide. Conceptualized as a medical specialty, concerned with the research, development, and monitoring of medicines, and spearheaded largely by pharmaceutical physicians, the discipline has extended to embrace non-medically qualified scientists progressively taking on traditional roles within the medicines development ambit.
View Article and Find Full Text PDFAnat Sci Educ
October 2024
Section of Anatomy, St George's University of London, London, UK.
Case-based learning (CBL) is a student-centered pedagogy where medical students are given a real-world clinical problem. At St George's University of London (SGUL), anatomy academics can volunteer to facilitate CBL sessions for pre-clinical undergraduate medical students. The major benefits of facilitating CBL sessions from the perspective of a non-medically qualified early career anatomy academic (ECAA) include exposure to clinical cases that help the academic develop an understanding over key clinical cases at the context of clinical anatomy and other disciplines including physiology, pathology, and pharmacology.
View Article and Find Full Text PDFAppl Clin Inform
March 2023
Department of Pediatrics, Section of Hospital Medicine, University of Colorado School of Medicine, Aurora, Colorado, United States.
Background: Identifying children ready for transfer out of the pediatric intensive care unit (PICU) is an area that may benefit from clinical decision support (CDS). We previously implemented a quality improvement (QI) initiative to accelerate the transfer evaluation of non-medically complex PICU patients with viral bronchiolitis receiving floor-appropriate respiratory support.
Objectives: Design a CDS tool adaptation of this QI initiative to further accelerate transfer evaluation of appropriate patients.