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Survey on the Situation of Medical Departments in the Pharmaceutical Industry in Spain
Survey on the Situation of Medical Departments in the Pharmaceutical Industry in Spain
Medical departments have evolved from a position of support to one of strategic leadership. The number of tasks and the co...
Advancing Rheumatology Care Through Machine Learning
Advancing Rheumatology Care Through Machine Learning
Rheumatologic diseases are marked by their complexity, involving immune-, metabolic- and mechanically mediated processes w...
Rare Immune-Related Adverse Events (irAEs): Approach to Diagnosis and Management
Rare Immune-Related Adverse Events (irAEs): Approach to Diagnosis and Management
Immune checkpoint inhibitors (ICIs) have revolutionised the treatment landscape across many solid organ malignancies and f...
Eliciting Exploratory Patient Preference Data: A Case Study in a Rare Disease
Eliciting Exploratory Patient Preference Data: A Case Study in a Rare Disease
Qualitative and quantitative methods provide different and complementary insights into patients’ preferences for tre...
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...
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 ...
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...
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 ...
The Impact of the Priority Review Voucher on Research and Development for Tropical Diseases
The Impact of the Priority Review Voucher on Research and Development for Tropical Diseases
In 2007, the priority review voucher (PRV) was implemented in the US to incentivize research and development (R&D)...
Dispositions and Causality Assessment in Pharmacovigilance: Proposing the Dx3 Approach for Assessing Causality with Small Data Sets
Dispositions and Causality Assessment in Pharmacovigilance: Proposing the Dx3 Approach for Assessing Causality with Small Data Sets
A new approach is proposed for assessing causality in pharmacovigilance. The Dx3 approach is designed to qualitatively eva...