Tarek A. Hammad
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View article: Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions
Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions Open
Post-authorization studies (PAS) are often mandated by regulatory authorities as a condition of marketing authorization of pharmaceutical products. This article explores specific regulations and trends in China, Japan, and South Korea, hig…
View article: Rethinking drug safety signal detection and causality assessment in the age of AI: the risks of incomplete data and biased insights
Rethinking drug safety signal detection and causality assessment in the age of AI: the risks of incomplete data and biased insights Open
View article: Teratogenic Risk Impact Mitigation (TRIM): Development of Explicit Criteria to Facilitate Decisions Regarding Teratogenic Risk Mitigation Strategies
Teratogenic Risk Impact Mitigation (TRIM): Development of Explicit Criteria to Facilitate Decisions Regarding Teratogenic Risk Mitigation Strategies Open
View article: Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness
Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness Open
Background: Pharmacovigilance (PV) inspections are critical regulatory assessments that evaluate the robustness and compliance of a company’s drug safety system. Despite their significance, there is limited published guidance on how organi…
View article: Impact of COVID-19 Pandemic on Treatment and Outcome of Patients With Femoropopliteal Peripheral Arterial Disease
Impact of COVID-19 Pandemic on Treatment and Outcome of Patients With Femoropopliteal Peripheral Arterial Disease Open
View article: Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance
Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance Open
View article: Exploring the complexities of disproportionality analysis in pharmacovigilance: reflections on the READUS-PV guideline and a call to action
Exploring the complexities of disproportionality analysis in pharmacovigilance: reflections on the READUS-PV guideline and a call to action Open
The use of disproportionality analysis (DA) in pharmacovigilance to detect signals of disproportionate reporting (SDRs) has gained popularity, resulting in a surge of publications based on aggregate analysis of spontaneously reported adver…
View article: Navigating Diverging Perspectives: Reasoning, Evidence, and Decision-Making in Drug Safety
Navigating Diverging Perspectives: Reasoning, Evidence, and Decision-Making in Drug Safety Open
View article: “The effect of accounting disclosure of environmental and social responsibility in the digital business environment to improve performance and maximize the value of an enterprise" (A field study on some cement industry companies)
“The effect of accounting disclosure of environmental and social responsibility in the digital business environment to improve performance and maximize the value of an enterprise" (A field study on some cement industry companies) Open
View article: Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates
Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates Open
View article: Exploring the scientific underpinnings of investigating safety signals: analytical insights in deciphering drug safety evidence
Exploring the scientific underpinnings of investigating safety signals: analytical insights in deciphering drug safety evidence Open
Ensuring the safety of drugs is a critical aspect of healthcare. Accurate interpretation of drug safety evidence is vital to understand the safety profile and to evaluate the benefits and risks of the medicinal product. However, validity o…
View article: THE IMPACT OF THE EGYPTIAN INDEX OF CORPORATE RESPONSIBILITY FOR SUSTAINABLE DEVELOPMENT ON FINANCIAL PERFORMANCE A FIELD STUDY ON SOME COMPANIES LISTED ON THE EGYPTIAN STOCK EXCHANGE
THE IMPACT OF THE EGYPTIAN INDEX OF CORPORATE RESPONSIBILITY FOR SUSTAINABLE DEVELOPMENT ON FINANCIAL PERFORMANCE A FIELD STUDY ON SOME COMPANIES LISTED ON THE EGYPTIAN STOCK EXCHANGE Open
View article: Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements
Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements Open
Contrary to the famous quote from Voltaire, “The art of medicine consists in amusing the patient, while nature cures the disease”, medicine has evolved since the 17th century into a multi-faceted scientific field facilitating healing and i…
View article: How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action
How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action Open
Objective: Patients have unique insights and are (in-)directly affected by each decision taken throughout the life cycle of medicinal products. Patient preference studies (PPS) assess what matters most to patients, how much, and what trade…
View article: Coronary Orbital Atherectomy Through Newly Deployed Left Main Coronary Stent
Coronary Orbital Atherectomy Through Newly Deployed Left Main Coronary Stent Open
Percutaneous coronary intervention (PCI) in complex, calcified coronary lesions can be assisted with orbital atherectomy (OA). OA is generally avoided when there are lesions amendable to OA distal to a newly deployed stent due to the risk …
View article: Aspects to consider in causality assessment of safety signals: broadening the thought process
Aspects to consider in causality assessment of safety signals: broadening the thought process Open
In the field of drug safety, causality assessment aims to determine the level of plausibility of the relationship between an adverse event and exposure to a particular product. It is after the causality assessment process that we will be a…
View article: A PROPOSED OUTLINE FOR ENHANCING SUSTAINABILITY IN SUPPLY CHAIN OVER THE VENDOR MANAGED INVENTORY SYSTEM COMPARATIVE STUDY
A PROPOSED OUTLINE FOR ENHANCING SUSTAINABILITY IN SUPPLY CHAIN OVER THE VENDOR MANAGED INVENTORY SYSTEM COMPARATIVE STUDY Open
View article: ECONOMIC FEASIBILITY STUDY AS AN INPUT TO RATIONALIZE FISHERIES MANAGEMENT SYSTEMS
ECONOMIC FEASIBILITY STUDY AS AN INPUT TO RATIONALIZE FISHERIES MANAGEMENT SYSTEMS Open
The study aims to identify the current situation of fisheries in the Arab Republic of Egypt. The study dealt with the organizational culture and its impact on economic feasibility, the most important factors affecting economic feasibility,…
View article: THE ROLE OF MANAGEMENT ACCOUNTING METHODS IN MINIMIZING THE RISK OF STRATEGIC DECISIONS IN THE ENVIRONMENTS OF EGYPTIAN BUSINESS ORGANIZATIONS A FIELD STUDY
THE ROLE OF MANAGEMENT ACCOUNTING METHODS IN MINIMIZING THE RISK OF STRATEGIC DECISIONS IN THE ENVIRONMENTS OF EGYPTIAN BUSINESS ORGANIZATIONS A FIELD STUDY Open
The study aims to study the role of management accounting methods in reducing the risks of strategic decisions in the business organization environment. For achieve the study goals the extrapolation method was used in the conceptual study …
View article: THE IMPACT OF LOGISTIC AND ENVIRONMENTAL FACTORS ON ACTIVITY OF SUPPLYING SHIPS WITH FUEL (BUNKERING) IN THE SUEZ CANAL REGION
THE IMPACT OF LOGISTIC AND ENVIRONMENTAL FACTORS ON ACTIVITY OF SUPPLYING SHIPS WITH FUEL (BUNKERING) IN THE SUEZ CANAL REGION Open
The study aims to improve the activity of supplying ships with fuel (Bunkering) in the ports located on the axis of the Suez Canal region, attracting local and foreign investments and developing the necessary logistic services that are com…
View article: Cardiovascular, electrophysiologic, and hematologic effects of omega-3 fatty acids beyond reducing hypertriglyceridemia: as it pertains to the recently published REDUCE-IT trial
Cardiovascular, electrophysiologic, and hematologic effects of omega-3 fatty acids beyond reducing hypertriglyceridemia: as it pertains to the recently published REDUCE-IT trial Open
Heart disease continues to affect health outcomes globally, accounting for a quarter of all deaths in the United States. Despite the improvement in the development and implementation of guideline-directed medical therapy, the risk of adver…
View article: PMU103 - INCORPORATING PSYCHOLOGICAL CONSTRUCTS INTO PATIENT PREFERENCE STUDIES: WHICH YOU SHOULD CONSIDER INCLUDING IN YOUR NEXT STUDY?
PMU103 - INCORPORATING PSYCHOLOGICAL CONSTRUCTS INTO PATIENT PREFERENCE STUDIES: WHICH YOU SHOULD CONSIDER INCLUDING IN YOUR NEXT STUDY? Open
View article: A PROPOSED FRAMEWORK FOR APPLYING THE VALUE ADDED IN LIGHT OF SOCIETAL RESPONSIBILITY - A FIELD STUDY
A PROPOSED FRAMEWORK FOR APPLYING THE VALUE ADDED IN LIGHT OF SOCIETAL RESPONSIBILITY - A FIELD STUDY Open
This study drives at measuring impact of the value added on societal responsibility, especially, its application in Egypt. The study also drives at identifying the importance and mechanisms of applying this tax, added to that establishing …
View article: Myocarditis Associated with Immune Checkpoint Inhibitors: An Expert Consensus on Data Gaps and a Call to Action
Myocarditis Associated with Immune Checkpoint Inhibitors: An Expert Consensus on Data Gaps and a Call to Action Open
Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for cancer. Due to the mechanism of action of ICIs, inflammatory reactions against normal tissue were an anticipated side effect of these agents; these immune-rel…
View article: Cancer recording in patients with and without type 2 diabetes in the Clinical Practice Research Datalink primary care data and linked hospital admission data: a cohort study
Cancer recording in patients with and without type 2 diabetes in the Clinical Practice Research Datalink primary care data and linked hospital admission data: a cohort study Open
Objectives and setting Conflicting results from studies using electronic health records to evaluate the associations between type 2 diabetes and cancer fuel concerns regarding potential biases. This study aimed to describe completeness of …
View article: Compendium Of Methods For Measuring Patient Preferences In Medical Treatment
Compendium Of Methods For Measuring Patient Preferences In Medical Treatment Open
View article: Cancer recording in patients with type 2 diabetes in primary care and hospital admission data
Cancer recording in patients with type 2 diabetes in primary care and hospital admission data Open
ObjectiveElectronic health records are increasingly used to investigate associations between antidiabetic therapy and cancer. Misclassification can impact results, especially if differential between comparators. The objective of this study…
View article: Prognostic value of an increase in post-exercise ankle–brachial index
Prognostic value of an increase in post-exercise ankle–brachial index Open
Prior studies have assessed the prognostic value of a decrease, not an increase, of the post-exercise ankle–brachial index (ABI) among patients with normal resting results. Thus, we sought to evaluate the prognostic significance of an incr…
View article: Patient Engagement at a Tipping Point—The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, “Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products”
Patient Engagement at a Tipping Point—The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, “Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products” Open
Benefit-risk assessment is the foundation for decision making throughout the life cycle of medical products. Because patients are the beneficiaries of the efficacy of medical treatments and also bear their possible risks, their perspective…
View article: Treatment of Infrapopliteal Disease in Critical Limb Ischemia
Treatment of Infrapopliteal Disease in Critical Limb Ischemia Open