Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements
Contrary to the famous quote from Voltaire, “The art of medicine consists in amusing the patient, while nature cures the disease”, medicine has evolved since the 17th century into a multi-faceted scientific field facilitating healing and improving overall wellbeing. One rapidly evolving area within...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-09-01
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| Series: | Frontiers in Drug Safety and Regulation |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1257732/full |
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| author | Tarek A. Hammad Salman Afsar Herve Le-Louet Herve Le-Louet Veronique F. Kugener |
| author_facet | Tarek A. Hammad Salman Afsar Herve Le-Louet Herve Le-Louet Veronique F. Kugener |
| author_sort | Tarek A. Hammad |
| collection | DOAJ |
| description | Contrary to the famous quote from Voltaire, “The art of medicine consists in amusing the patient, while nature cures the disease”, medicine has evolved since the 17th century into a multi-faceted scientific field facilitating healing and improving overall wellbeing. One rapidly evolving area within this field is drug safety, also known as pharmacovigilance (PV). PV identifies and evaluates potential risks throughout the life cycle of the drug, minimizing patient exposure to harmful effects and guiding appropriate risk mitigation and management strategies. Timely identification and mitigation of risks not only contribute to patient safety but also allows maximum therapeutic benefits while curtailing economic burden associated with adverse events. In the evolving landscape of drug safety, the role of the PV physicians has emerged as an integral component of drug development. This paper aims to explore the evolving nature of PV physicians’ roles in drug development, highlighting changing landscape in drug development and safety monitoring and attendant changes and advancements in responsibilities, scope, and training implications. To be well-rounded, PV physicians are encouraged to strive to undergo relevant training and education. This would enable them to leverage pertinent complementary fields of science by developing the proficiency to ask the right questions, acknowledge multidisciplinary perspectives, and interpret the overall evidence. While on-the-job training is valuable for gaining experience, building a future safety workforce necessitates more targeted efforts, especially considering that medical school curricula may not readily emphasize the development of skills required for successful PV physician roles. Therefore, academic centers, pharmaceutical companies, and regulatory agencies should increase collaboration to establish hands-on training opportunities through post-doctoral, internship, and fellowship programs, in order to meet the growing demand for well-trained PV physicians. |
| format | Article |
| id | doaj-art-cf0adf7e722747a69928187fe388b58a |
| institution | Kabale University |
| issn | 2674-0869 |
| language | English |
| publishDate | 2023-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Drug Safety and Regulation |
| spelling | doaj-art-cf0adf7e722747a69928187fe388b58a2024-11-25T14:12:34ZengFrontiers Media S.A.Frontiers in Drug Safety and Regulation2674-08692023-09-01310.3389/fdsfr.2023.12577321257732Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirementsTarek A. HammadSalman Afsar0Herve Le-Louet1Herve Le-Louet2Veronique F. Kugener3Medical Safety Assessment Physician and Program Lead, Worldwide Patient Safety, Bristol Myers Squibb, Princeton, NJ, United StatesHead of PV Policy Intelligence Strategy, Global Patient Safety Evaluation, Takeda Pharmaceuticals Inc, Cambridge, MA, United StatesPresident of the Council for International Organizations of Medical Sciences (CIOMS), Geneva, SwitzerlandHead of Global Patient Safety Evaluation, Takeda Pharmaceuticals Inc, Cambridge, MA, United StatesContrary to the famous quote from Voltaire, “The art of medicine consists in amusing the patient, while nature cures the disease”, medicine has evolved since the 17th century into a multi-faceted scientific field facilitating healing and improving overall wellbeing. One rapidly evolving area within this field is drug safety, also known as pharmacovigilance (PV). PV identifies and evaluates potential risks throughout the life cycle of the drug, minimizing patient exposure to harmful effects and guiding appropriate risk mitigation and management strategies. Timely identification and mitigation of risks not only contribute to patient safety but also allows maximum therapeutic benefits while curtailing economic burden associated with adverse events. In the evolving landscape of drug safety, the role of the PV physicians has emerged as an integral component of drug development. This paper aims to explore the evolving nature of PV physicians’ roles in drug development, highlighting changing landscape in drug development and safety monitoring and attendant changes and advancements in responsibilities, scope, and training implications. To be well-rounded, PV physicians are encouraged to strive to undergo relevant training and education. This would enable them to leverage pertinent complementary fields of science by developing the proficiency to ask the right questions, acknowledge multidisciplinary perspectives, and interpret the overall evidence. While on-the-job training is valuable for gaining experience, building a future safety workforce necessitates more targeted efforts, especially considering that medical school curricula may not readily emphasize the development of skills required for successful PV physician roles. Therefore, academic centers, pharmaceutical companies, and regulatory agencies should increase collaboration to establish hands-on training opportunities through post-doctoral, internship, and fellowship programs, in order to meet the growing demand for well-trained PV physicians.https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1257732/fullpharmacovigilancerole of pharmacovigilance physicianssafety physiciansevidence-based medicineenhanced safety surveillance technologiespharmacovigilance physician training requirements |
| spellingShingle | Tarek A. Hammad Salman Afsar Herve Le-Louet Herve Le-Louet Veronique F. Kugener Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements Frontiers in Drug Safety and Regulation pharmacovigilance role of pharmacovigilance physicians safety physicians evidence-based medicine enhanced safety surveillance technologies pharmacovigilance physician training requirements |
| title | Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements |
| title_full | Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements |
| title_fullStr | Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements |
| title_full_unstemmed | Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements |
| title_short | Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements |
| title_sort | navigating a transforming landscape the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements |
| topic | pharmacovigilance role of pharmacovigilance physicians safety physicians evidence-based medicine enhanced safety surveillance technologies pharmacovigilance physician training requirements |
| url | https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1257732/full |
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