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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...
Pioneering the Future of Medical Affairs: A Strategic Transformation to Meet the Spanish Healthcare Ecosystem’s Evolving Trends
Pioneering the Future of Medical Affairs: A Strategic Transformation to Meet the Spanish Healthcare Ecosystem’s Evolving Trends
The role of medical affairs (MA) in the pharmaceutical industry is undergoing a profound transformation, driven by the inc...
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...
P.O.L.A.R. Star: A New Framework Developed and Applied by One Mid-Sized Pharmaceutical Company to Drive Digital Transformation in R&D
P.O.L.A.R. Star: A New Framework Developed and Applied by One Mid-Sized Pharmaceutical Company to Drive Digital Transformation in R&D
Digital transformation has become a cornerstone of innovation in pharmaceutical research and development (R&D). Ph...
Evaluation of the Effectiveness of Additional Risk Minimization Measures for Ixazomib Citrate for Relapsed/Refractory Multiple Myeloma in Japan: A Web-Based Survey Among Pharmacists
Evaluation of the Effectiveness of Additional Risk Minimization Measures for Ixazomib Citrate for Relapsed/Refractory Multiple Myeloma in Japan: A Web-Based Survey Among Pharmacists
Ixazomib citrate (IXA) in combination with lenalidomide and dexamethasone (IRD therapy) has been approved for the treatmen...
Artificial Intelligence in Medical Affairs: A New Paradigm with Novel Opportunities
Artificial Intelligence in Medical Affairs: A New Paradigm with Novel Opportunities
The advent of artificial intelligence (AI) revolutionizes the ways of working in many areas of business and life science. ...
Automated Mass Extraction of Over 680,000 PICOs from Clinical Study Abstracts Using Generative AI: A Proof-of-Concept Study
Automated Mass Extraction of Over 680,000 PICOs from Clinical Study Abstracts Using Generative AI: A Proof-of-Concept Study
Generative artificial intelligence (GenAI) shows promise in automating key tasks involved in conducting systematic literat...
European Pharmaceutical Industry Medical Information: A Role to Play in the Provision of Medicine-Related Information to Patients
European Pharmaceutical Industry Medical Information: A Role to Play in the Provision of Medicine-Related Information to Patients
European pharmaceutical companies have a professional and legal obligation to provide objective, factual and non-promotion...
Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review
Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review
In the context of biosimilar use and switching, a patient’s negative perception of a biosimilar might trigger a noce...
Understanding the National Healthcare Ecosystem to Position Medical Affairs as a Strategic Element: Lessons Learned from AstraZeneca Spain
Understanding the National Healthcare Ecosystem to Position Medical Affairs as a Strategic Element: Lessons Learned from AstraZeneca Spain
The rapidly evolving healthcare landscape has prompted Medical Affairs (MA) departments within pharmaceutical companies to...
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...
The Evolution of In-Field Medical Affairs: Introducing the Strategic Scientific Advisor
The Evolution of In-Field Medical Affairs: Introducing the Strategic Scientific Advisor
The evolving landscape of healthcare demands a transformation in Medical Affairs (MA) to address new challenges and opport...
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...
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...
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...
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...
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 Importance of Assessing Drug Exposure and Medication Adherence in Evaluating Investigational Medications: Ensuring Validity and Reliability of Clinical Trial Results
The Importance of Assessing Drug Exposure and Medication Adherence in Evaluating Investigational Medications: Ensuring Validity and Reliability of Clinical Trial Results
The objective of this current opinion paper is to draw global attention to medication adherence, emphasizing its crucial r...
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...
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 ...
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