HCR 577 Euphrosyne (sertraline) Summary This presentation examines the introduction of Euphrosyne (sertraline), a form of the SSRI drug, into the German market. The drug is usually applied to treat mental health conditions like depression, PTSD, OCD, panic disorder, PMDD, and social anxiety, as explained by Ehlers et al. (2024). It is orally administered and […]
HCR 593 Applied Project Reflection This applied project was one of the key experiences during my course in Regulatory Science. The purpose of the study I conducted was to evaluate the effectiveness of the Food Safety and Inspection Service (FSIS) in the control of contamination of ready-to-eat (RTE) meat and poultry products by the Listeria […]
HCR 577 Module 6 Discussion Post Comparison of the Impact of Biosimilars: US, Asia, Canada, and Emerging Markets The effects of biosimilars have transformed healthcare systems in various parts of the world, although not in all regions. Biosimilars have great potential in terms of cost-saving in healthcare in the United States, particularly with numerous high-selling […]
HCR 577 CTD Module 1 2 3 4 and 5 Table of Contents Module 1 Administrative Information————————————————————16 1.1 Form – headline in TOC—————————————————————————16 1.2 Cover letters——————————————————————————————16 1.3 Administrative information————————————————————————17 1.3.1 Contact/sponsor/applicant information——————————————————–17 1.3.1.1 Change of address or corporate name——————————————————–18 1.3.1.2 Change in contact/agent———————————————————————–18 1.3.1.3 Change in sponsor—————————————————————————–18 1.3.1.4 Transfer of obligation————————————————————————19 1.3.1.5 Change in ownership […]
HCR 577 Course Reflection I thought I knew a lot about regulation before I began HCR 577: Global Regulatory Affairs, because I am a Food Safety Investigator with the FDA with more than two decades of experience. I work to ensure the safety of food products through regulation enforcement, inspections, and the control of unsafe […]
HCR 577 Current Trends and Issues in the Conduct of Global Clinical Trials Table of Contents Abstract—————————————————————————————-3 Introduction ———————————————————————————–4 Trend/Issue and Relevance to Current Industry Issues———————————–4 Legal Issues————————————————————————————-5 Policies and Laws——————————————————————————5 Special Considerations————————————————————————-6 Recommendations——————————————————————————6 Conclusion—————————————————————————————7 References ————————————————————————————–8 Abstract Access to medicine is a global health challenge. Biologics are becoming more widely accessible to […]
HCR 577 Final Exam Discuss the impact of increased prescription drug costs. Rising prescription drug prices can have devastating effects on people. Drugs can be expensive to afford every month. A 2025 GoodRx survey found that 67% of people who filled a prescription said the cost was a burden (Bear, 2026). The report also found […]
SOWK 510: Theoretical Framework on Chronic Absenteeism and Street Activities Among African American Youth in Baltimore The theoretical framework for this study on chronic absenteeism and street activities among African American youth in Baltimore is anchored in two fundamental theories. This paper is based on two theories: the Social Disorganization Theory and the Ecological Systems […]
SOWK 501-Social Welfare Pioneer Paper Social Welfare Pioneer Paper: Dr. Ibram X. Kendi Dr. Ibram X. Kendi has become one of the leading figures in modern antiracist discourse. His impact on scholarship and social well-being is immense and revolutionary, especially on issues related to systematic racism and policies. Even when looking at what he has […]
SOWK 510 Part 3 Methodology Section This study uses quantitative and qualitative approaches to analyze absenteeism and street activities among African American youths in Baltimore. Social Disorganization Theory and Ecological System Theory form the foundation of this study as they offer insight into how social and environmental factors affect youths’ behavior in urban areas. The […]
