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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...
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...
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...
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...
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...
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...
Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials
Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials
The Sleep Diary Questionnaire (SDQ), a modified version of the Consensus Sleep Diary, is a 17-item sleep diary for assessi...
Physician Awareness of the Safe Use of Cyproterone Acetate in Europe: A Survey on the Effectiveness of Additional Risk Minimization Measures
Physician Awareness of the Safe Use of Cyproterone Acetate in Europe: A Survey on the Effectiveness of Additional Risk Minimization Measures
Cyproterone acetate (CPA) is a synthetic progesterone derivative introduced in the 1970s and prescribed as antiandrogenic ...
Considerations for Planning Effective and Appealing Advisory Boards and Other Small-Group Meetings with Health Care Providers: Importance of Participant Preferences
Considerations for Planning Effective and Appealing Advisory Boards and Other Small-Group Meetings with Health Care Providers: Importance of Participant Preferences
To optimize cost effectiveness, engagement, reach, inclusivity, insight quality and quantity, and participant satisfaction...
How Can General Managers Best Leverage Medical Affairs Now and in the Future?
How Can General Managers Best Leverage Medical Affairs Now and in the Future?
General managers (GMs) play a crucial role as enterprise leaders of the country affiliate of multi-national pharmaceutical...
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...
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 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...
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...
A Sponsor’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan
A Sponsor’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan
Following marketing authorization in Japan, for almost all new drugs or new indications, postmarketing studies (PMS) are a...
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...
Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics
Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics
The Summary of Product Characteristics (SmPC) is required to provide unambiguous information on the authorized use of a me...
Maximizing the Value of Real-World Data and Real-World Evidence to Accelerate Healthcare Transformation in China: Summary of External Advisory Committee Meetings
Maximizing the Value of Real-World Data and Real-World Evidence to Accelerate Healthcare Transformation in China: Summary of External Advisory Committee Meetings
Use of real-world data (RWD) is gaining wide attention. To bridge the gap between diverse healthcare stakeholders and to l...
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...
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