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Professional & Student Poster Presentations
Professional
- P101: Optimizing the i-access Pregnancy Prevention Program to Improve how Immunomodulatory Drugs (IMiDs) are Dispensed
- P102: Risk Assessment of Arterial Aneurysms and Dissections in Cancer Patients Treated with Oral VEGFR-TKIs using Real-World Data
- P103: A Robust Data Analysis Tool to Characterize the Safety Profile of Medicines Prescribed to Women While Pregnant or Lactating
- P104: CIOMS XI Recommends Patients are Involved in the Development, Regulation and Safe Use of Medicines: Is Industry Doing Enough?
- P105: Regional Prescribing Patterns of Ivermectin and Zinc Sulfate during the COVID-19 Pandemic in New York State
- P106: Drug-induced Liver Injury – Significance in Premarketing Clinical Trials
- P107: Perspectives of Canadian Ophthalmologists on Biosimilars
- P108: Oncology Drugs in Clinical Trials with Healthy Populations: Old Challenges or New Opportunities
- P109: Impact of the FDA’s Revised Draft Guidance on Renal Impairment PK Studies – Trends, Challenges, and Solutions
- P110: Clinically Relevant Analysis of Safety Data from Clinical Studies utilising Burden of Therapy, Both Methodology
- P111: Remote Monitoring of Adverse Event Under-Reporting in Clinical Trials: Implications for Critical to Quality Issue Detection
- P112: Data-driven Clinical Trial Execution from Start-Up to Closure
- P113: Increasing Operational Efficiency: Consolidating Long-term Follow-up Activities in Cell Therapy Clinical Trials
- P114: Introducing the Independent Safety Analysis Team (iSAT): a Sponsor-Employed, Fully Unblinded, Independent Analysis Team
- P115: A Comparative Investigation of the AAHRRP Accreditation and Clinical Research Core Hospital System in Japan
- P116: Testing a Nutritional Intervention on Sleep Quality Outcomes: Insights Into Design and Operational Challenges
- P117: Where are the Pediatricians in Clinical Research?
- P118: Efficient, Accurate, and Precise: Data Monitoring Committee Summaries and Resulting Recommendations
- P119: Design and Implementation of Blinding Procedures for Blood Products in the VA During the COVID-19 Pandemic
- P120: A Novel Approach: Leveraging the “Affective Trust Framework” to Develop a Sponsor-specific Clinical Trial Diversity Playbook
- P121: Development of a 21 CFR Part 11 Compliant Dashboard for a Wearable Biosensor Device for Clinical Research
- P122: A Step in the Right Direction to Reduce Financial Burden of Clinical Study Participation: Patient Compensation Calculator
- P123: Cutaneous T-Cell Lymphoma Identified during Screening for Decentralized Clinical Trial for Atopic Dermatitis - A Case Study
- P124: Real-World Data in Comparative Effectiveness Research: Impacts of Pharmacotherapy and Social Determinants of Health
- P125: Developing a Bridge for Small Chinese Biotech Companies to Conduct Clinical Trials in the US
- P126: Remote Psychometric Assessments are Comparable in Quality to In-Person Administration: Evidence from Two Depression Trials
- P127: Experience Sharing on a Special Legislation Incorporating Rare Diseases, Orphan Drugs, and Patients Safeguarding
- P201: The Future Utilization of Digital Display Labeling in Clinical Supplies for Human Clinical Trials
- P202: Analysis Model Development with Patient Data in Atopic Dermatitis using Automated Machine Learning
- P203: Respiratory Syncytial Virus Infection in Long-term Care Facilities: Clinical Characteristics and Outcomes
- P204: Connected Drug Delivery Devices: Satisfying the Needs of Patients, Healthcare Professionals, and Regulators
- P206: Program Level Data Strategy: Standardization of the Data Collection for an Integrated Submission at a Program Level
- P207: Revitalizing Innovation: An Employee-centric Approach to Solution Delivery in an Emerging Value Network
- P208: An Immunotherapy Registry to Study Safety Signals
- P209: Understanding Health Related Challenges in Patients with Alpha-Gal Syndrome
- P210: Trends in Medical Information
- P211: Automated Similarity Search for Enhanced Content Retrieval in Scientific Communications
- P212: Benchmarking Analysis of Direct-to-Consumer Web-based Information for Non-Small Cell Lung Cancer (NSCLC) Treatment Options
- P213: Real-World Outpatient Cost of Care among Patients with Metastatic, Castrate-resistant Prostate Cancer (mCRPC)
- P214: Medical Information: Embracing Digital Transformation to Ensure Customer Centricity
- P215: Understanding the Patient Experience: Health Inequities, Community Engagement, and Clinical Trial Participation
- P216: Combining Real-World Data Sets to Deepen Understanding of the Patient Experience
- P217: Patient Disease Strategy: A Framework for Collecting and Applying Patient Experience Data into Clinical Development Programs
- P218: Decentralized Mobile Visit Services for Rare Diseases: Amyotrophic Lateral Sclerosis
- P219: Assessment of Genomic Profiling in Colorectal Cancer Patients Treated in Community Oncology Practices
- P220: Leveraging Outcomes Research and Analytics to Power Cross-Functional Business Development and Governance Decision Making
- P221: Transformation of Drug Development for the 21st Century: Primary Disease Biomarkers
- P222: Continuous Innovation and Transformation Amidst Organizational and Regulatory Complexities
- P223: The Benefit of Bridging Study Strategy Consultation in Taiwan CDE
- P224: Evaluation of New Medicines in SAHPRA’s Backlog Clearance Project: The Impact of Reliance on Regulatory Performance
- P225: Global Regulatory Landscape of Complex Generics
- P226: A Comparison of the Regional Medicines Regulatory Harmonisation Projects in East, West and Southern Africa
- P227: Immuno-bridging in the Evaluation of Novel COVID-19 Vaccine EUA in Asia: A Regulatory Perspective and Experience Sharing
- P228: Measuring Time-to-market for New Medicines in Seven Asian Countries between 2016-21, following Review by US FDA or EMA
- P230: Putting Guidance Into Practice: Designing Container Labels with Patient Safety in Mind
- P231: Maximizing the Impact of Regional Regulatory Initiatives: A Comparative Analysis of Process Characteristics
- P232: Trends in Saudi FDA Drug Approvals and GMP Inspections: An Observational Study
- P233: Accelerating Cell Therapy Development and Improving Quality in Manufacturing by New Regulation Framework in Taiwan
- P234: The ICH E9(R1) Estimand Framework Implemented in a Phase III Equivalence RCT Conducted during COVID-19 Pandemic - A Case Study
- P235: Linear Biomarker Combinations to Minimize the Distance of the Closest Point on the ROC Surface to the Perfection Corner
- P236: Considerations for Multiple Enrollment Subject Data for Analysis and Reporting
Student
- S129: The Comparison of AAV Gene Therapy Products, Onasemnogene Abeparvovec and Resamirigene Bilparvovec, in Pediatric Patients
- S130: Analysis of Quality of Life Patient-Reported Outcomes in Clinical Trials for Parkinson’s Disease from 2010-2021
- S131: Predicting Mortality among Patients with Colorectal Cancer using Big Data: A Machine Learning Approach
- S132: In Vitro Analysis of Embelin in Combination with Tyrosine Kinase Inhibitors for Treating Breast Cancer
- S133: Psilocybin Clinical Trials for Terminally Ill Patients with Depression: Legal and Cultural Challenges across Three Countries
- S134: Evaluation of the Regulatory Review Process of the FDA Ghana: Challenges and Opportunities for Improvement
- S135: Evaluation of the Effectiveness and Efficiency of Ten Years’ Experience with the East African Community Joint Assessment
- S136: Exploring the Regulatory Framework and Ethical Considerations of Pediatric Psilocybin Research in US, Europe, and Canada
- S137: A Study on the Influencing Factors Related to the Effectiveness of Centralized Drug Procurement