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The Value and Importance of a Professional Ethical Code for Medicines Development: IFAPP International Ethics Framework
The Value and Importance of a Professional Ethical Code for Medicines Development: IFAPP International Ethics Framework
Pharmaceutical medicine professionals have to face many ethical problems during the entire life span of new medicines exte...
Safety Warnings on the Same Harmful Effects of Medicines: A Comparison of Four National Regulators
Safety Warnings on the Same Harmful Effects of Medicines: A Comparison of Four National Regulators
Safety advisories provide critical information to clinicians and patients on the harms of medicines. Previous research has...
Treatment Persistence in Rheumatoid Arthritis Before and After Etanercept Biosimilar Introduction: A Nationwide Australian Real-World Study
Treatment Persistence in Rheumatoid Arthritis Before and After Etanercept Biosimilar Introduction: A Nationwide Australian Real-World Study
Australia has one of the highest rates of rheumatoid arthritis (RA) worldwide. Etanercept, a widely used biologic for seve...
Utilization of Evidence Blueprint Initiative to Transform Capability Development in AstraZeneca Spain
Utilization of Evidence Blueprint Initiative to Transform Capability Development in AstraZeneca Spain
The role of Medical Affairs (MA) has shifted from traditional evidence dissemination to an integrated process leveraging r...
A Framework for Considering the Role of the Public Sector in R&D of Health Technology
A Framework for Considering the Role of the Public Sector in R&D of Health Technology
The development of health technologies involves complex, costly, and risky investments, with significant contributions fro...
Awareness and Experience of Direct Healthcare Professional Communication and Risk Management Plan Educational Material among Healthcare Professionals in Finland
Awareness and Experience of Direct Healthcare Professional Communication and Risk Management Plan Educational Material among Healthcare Professionals in Finland
Additional risk minimization measures (aRMMs), such as direct healthcare professional communication (DHPC) and risk manage...
Development of a Competency Framework for Medical Affairs Professionals in Australasia
Development of a Competency Framework for Medical Affairs Professionals in Australasia
Medical Affairs (MA) plays a critical role in bridging the gap between research, clinical practice and business strategy. ...
The Utility of Tissue-Agnostic Drugs in Lung Cancer Treatment
The Utility of Tissue-Agnostic Drugs in Lung Cancer Treatment
Tissue-agnostic therapies, which target molecular alterations across cancer types, have been approved by the US Food and D...
The Evolution of Medical Affairs Central Teams: Shaping Strategic Action and Driving Healthcare Transformation Through Scientific Interaction
The Evolution of Medical Affairs Central Teams: Shaping Strategic Action and Driving Healthcare Transformation Through Scientific Interaction
The evolving role of Medical Affairs (MA) has positioned this department as a key element in the development and lifecycle...
Studies of Cannabinoid-Based Products in ClinicalTrials.gov: A Scoping Review
Studies of Cannabinoid-Based Products in ClinicalTrials.gov: A Scoping Review
There is increased interest in using cannabinoid-based products for therapeutic purposes. Because of unique regulatory cha...
Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices
Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices
Comprehensible reporting of clinical trial safety data is essential for multiple stakeholders, including ongoing safety re...
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...
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