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The Economic Impact of Reliance on an African Medicines Regulatory Authority
The Economic Impact of Reliance on an African Medicines Regulatory Authority
The inherited backlog of 16,000 medicines applications of the South African Health Products Regulatory Authority (SAHPRA) ...
Suggested Improvements to the Current East African Community Medicines Regulatory Harmonization Joint Review Process and a Proposed New Review Model for this Initiative
Suggested Improvements to the Current East African Community Medicines Regulatory Harmonization Joint Review Process and a Proposed New Review Model for this Initiative
In 2012, the East African Community Medicines Regulatory Harmonization (EAC-MRH) initiative was established to improve acc...
Compliance with Cyproterone Contraindications and Meningioma Risk: Resource-Efficient Use of Aggregated Statistics from Swedish National Health Registers
Compliance with Cyproterone Contraindications and Meningioma Risk: Resource-Efficient Use of Aggregated Statistics from Swedish National Health Registers
Funding No funding was received for the preparation of this...
Visionary Health Architects and Leaders: The Strategic Role of Medical Advisors in Modern Pharma
Visionary Health Architects and Leaders: The Strategic Role of Medical Advisors in Modern Pharma
This paper reviews the pivotal role of the Medical Advisor (MA) within the medical department of the pharmaceutical indust...
Cost and Duration of Clinical Trials in Drug Development by Japanese Pharmaceutical Companies
Cost and Duration of Clinical Trials in Drug Development by Japanese Pharmaceutical Companies
Understanding parameters such as cost and duration, which reflect the scale of clinical trials, is essential for governmen...
Importance of Health Economics and Outcomes Research in the Product Lifecycle
Importance of Health Economics and Outcomes Research in the Product Lifecycle
Health economics and outcomes research (HEOR) has become an integral part of healthcare systems, through its ability to au...
Artificial Intelligence: Applications in Pharmacovigilance Signal Management
Artificial Intelligence: Applications in Pharmacovigilance Signal Management
Pharmacovigilance is the science of collection, detection, and assessment of adverse events associated with pharmaceutical...
A Model for an Academia-Industry Collaboration for Pharmacovigilance and Pharmacoepidemiology
A Model for an Academia-Industry Collaboration for Pharmacovigilance and Pharmacoepidemiology
Collaborations between academia and the pharmaceutical industry are common for drug development and clinical trials, but r...
Transforming Care in China by Using Public–Private Partnerships to Unlock the Power of Patient-Centered Real-World Data
Transforming Care in China by Using Public–Private Partnerships to Unlock the Power of Patient-Centered Real-World Data
The transformation of China’s healthcare system is increasingly driven by the development of real-world data (RWD) a...
Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials
Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials
Materials have been distributed in the European Union to inform physicians on the safe use of intravitreal aflibercept (IV...
The Value and Deliverables of Medical Affairs: Affiliate Perspectives and Future Expectations
The Value and Deliverables of Medical Affairs: Affiliate Perspectives and Future Expectations
The Medical Affairs (MA) function in pharmaceutical companies creates a unique opportunity to ensure the internal linkage ...
The Pharmacokinetics of Drugs Delivered to the Upper Nasal Space
The Pharmacokinetics of Drugs Delivered to the Upper Nasal Space
Pharmacokinetics (PK) includes how a drug is absorbed, distributed, metabolized and eliminated. The compartment providing ...
Journey from an Enabler to a Strategic Leader: Integration of the Medical Affairs Function in ESG Initiatives and Values
Journey from an Enabler to a Strategic Leader: Integration of the Medical Affairs Function in ESG Initiatives and Values
Like most private enterprises, the pharmaceutical industry has deeply rooted environmental, social, and governance (ESG) m...
A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia
A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia
In Australia, facilitated regulatory pathways (FRPs) became available with the introduction of priority review (PR) in 201...
Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant
Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a new validated 14-item patient-reported outcome (PRO) ...
Embedding Patient-Centricity by Collaborating with Patients to Transform the Rare Disease Ecosystem
Embedding Patient-Centricity by Collaborating with Patients to Transform the Rare Disease Ecosystem
What is patient-centricity? In some contexts, it has been associated with targeting therapies based on biomarkers or enabl...
A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials
A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials
Multiple components factor into the assessment of combination safety risks when two or more novel individual products are ...
Medical Information Delivering Improved Customer Experience: A Guide
Medical Information Delivering Improved Customer Experience: A Guide
Customer experience (CX) is essential in any business. In the pharmaceutical industry, the Medical Information Contact Cen...
A Principles Framework for Digital Provision of Medical Information for Healthcare Professionals
A Principles Framework for Digital Provision of Medical Information for Healthcare Professionals
European pharmaceutical companies have a legal requirement to provide non-promotional medical information (MI) services to...
Clinical Presentations of Drug-Induced Hyperprolactinaemia: A Literature Review
Clinical Presentations of Drug-Induced Hyperprolactinaemia: A Literature Review
Screening for drug-induced hyperprolactinaemia, a condition characterised by higher-than-normal levels of serum prolactin ...
Assessing Definitions and Incentives Adopted for Innovation for Pharmaceutical Products in Five High-Income Countries: A Systematic Literature Review
Assessing Definitions and Incentives Adopted for Innovation for Pharmaceutical Products in Five High-Income Countries: A Systematic Literature Review
The concept of health care innovation varies across organizations and countries. Harmonizing the definitions of innovation...
Drug-Induced Gambling Disorder: Epidemiology, Neurobiology, and Management
Drug-Induced Gambling Disorder: Epidemiology, Neurobiology, and Management
Problematic gambling has been suggested to be a possible consequence of dopaminergic medications used mainly in neurologic...
The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA)
The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA)
An extensive backlog of pending regulatory decisions is one of the major historical challenges that the South African Heal...
Correction to: The Impact of the Priority Review Voucher on Research and Development for Tropical Diseases
Correction to: The Impact of the Priority Review Voucher on Research and Development for Tropical Diseases
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International L...
A Structured Methodology to Assess Safety Signal Strength and Inform Causality Assessment
A Structured Methodology to Assess Safety Signal Strength and Inform Causality Assessment
Causality assessment of safety signals observed with medicinal products is a foundational element of pharmacovigilance and...
Potential Channeling Bias in the Evaluation of Cardiovascular Risk: The Importance of Comparator Selection in Observational Research
Potential Channeling Bias in the Evaluation of Cardiovascular Risk: The Importance of Comparator Selection in Observational Research
Comparator selection is an important consideration in the design of observational research studies that evaluate potential...
Evaluation of the Performance of the Gulf Cooperation Council Centralised Regulatory Review Process: Strategies to Improve Product Authorisation Efficiency and Quality
Evaluation of the Performance of the Gulf Cooperation Council Centralised Regulatory Review Process: Strategies to Improve Product Authorisation Efficiency and Quality
The Gulf Centralised Committee for Drug Registration (GCC-DR), as part of the Gulf Health Council (GHC), enables the conso...
An Industry Survey on Managing the Pharmacovigilance System Master File in a Global Environment: The Need for a Pragmatic Approach
An Industry Survey on Managing the Pharmacovigilance System Master File in a Global Environment: The Need for a Pragmatic Approach
Legislative requirements for Marketing Authorisation Holders (MAHs) to maintain a Pharmacovigilance System Master File (PS...
Barriers to Chimeric Antigen Receptor T-Cell (CAR-T) Therapies in Clinical Practice
Barriers to Chimeric Antigen Receptor T-Cell (CAR-T) Therapies in Clinical Practice
Chimeric antigen receptor T-cell (CAR-T) therapy is a revolutionary cancer treatment modality where a patient’s own ...
Calling for Unity, Solidarity, Continuity, and Access-Oriented Action in Times of War
Calling for Unity, Solidarity, Continuity, and Access-Oriented Action in Times of War
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