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Pharmacovigilance

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Development of Pharmacovigilance Training Modules for US-based Educational Institute

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Customer Requirement: A USA-based educational institute specializing in providing training courses to its subscribers was looking to develop a course on pharmacovigilance. This course would be the first of its kind for the educational institute and would aim to provide a robust foundational knowledge base of pharmacovigilance, including key activities, processes, and the regulations surrounding […]

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Kenya’s Systematic Approach to Pharmacovigilance

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Pharmacovigilance (PV) and drug safety surveillance activities rely on a robust PV system. This is important to effectively identify, evaluate, and address any adverse events (AEs) that are associated with medicinal products. Indeed, a proficient PV system facilitates data gathering that is critical for making informed decisions across various health systems. Regulatory agencies are reliant

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ISoP: The Need for Patient Engagement in Pharmacovigilance

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Pharmacovigilance is paramount for the well-being of patients exposed to pharmaceutical products. To ensure the effectiveness of pharmacovigilance systems professionals from various scientific disciplines contribute in diverse manner. Several organizations collaborate to ensure best global pharmacovigilance practices for patient safety. Among these key organizations is the International Society of Pharmacovigilance (ISoP) that is dedicated to patient

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Pharmacovigilance in Herbal and Alternative Medicine

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At the turn of the millennium, guidelines for post-marketing safety reporting of herbal medicines were introduced by the World Health Organization (WHO) in the period between 1999 and 2001. The fact that more than 158 million people in the United States alone spent over 17.6 billion dollars on herbal medicines in the year 2000 is

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Ensuring Safe Use of Medical Devices in Healthcare Facilities

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The safe and effective use of medical devices in healthcare facilities is not merely a matter of convenience; it is a moral obligation. The welfare of patients and the quality of healthcare services depend on the responsible use of these devices. Accidents involving medical devices can have dire consequences for patients. These accidents may result

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Post-market safety data for underrepresented populations in clinical trials

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Introduction Regulatory agencies require sponsors to collect and provide data on the safety and efficacy of drugs that they have obtained from clinical trials. In addition to age, gender, and racial subgroups, these trials should also incorporate data on patient populations that are historically underrepresented in clinical research. Indeed, information from a diverse patient population

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CDER: Creating efficiencies in pharmaceutical development and manufacturing

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The Center for Drug Evaluation and Research (CDER) of the US FDA outlined a program in February 2019 in which various stakeholders of the industry could propose pharmaceutical quality standards for recognition by the CDER. This would provide the industry with additional resources for the development and manufacturing of pharmaceuticals. In July 2023, the CDER

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The Impact of Artificial Intelligence in the Lifecycle of Medicines

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The rapid digitalization of the biomedical and clinical research sectors has ushered in a new era of advancements, with artificial intelligence (AI) taking centre stage as a transformative solution. In particular, AI is revolutionizing drug discovery processes by harnessing the vast amount of data generated during molecule screening phases and preclinical studies. As a result,

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The Future of Certificate of Suitability

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The Certificate of Suitability (CEP) to the monographs of the European Pharmacopoeia (Ph. Eur.) plays a crucial role in verifying the quality standards of active pharmaceutical ingredients (APIs). Issued by the European Directorate for the Quality of Medicines (EDQM), the CEP serves as evidence that an API complies with the rigorous quality requirements outlined in

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US FDA: Resolving Disputes for Over-the-Counter Monograph Drugs

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Over-The-Counter (OTC) monographs define the safety, effectiveness, and labelling of the active ingredients in OTCs. The US FDA released a guidance document that provides suggestions for industry and review staff on resolving scientific and medical disputes related to OTC monograph drugs. It describes the Center for Drug Evaluation and Research (CDER) formal dispute resolution (FDR)

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