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Professional & Student Poster Presentations
Student
- P100: Unveiling Pharmacokinetic Variations in HER2-Targeting Antibodies: Implications for Personalized Breast Cancer Therapy
- P101: Impact of China's Volume-Based Procurement Policy on Pharmaceutical Enterprise Development
- P102: Investigating the Prevalence of Antibiotic-Resistant Bacteria in Freshwater Near High-Risk Locations in Kent County Delaware
- P103: Seizure Risk Among Older Adults with Metastatic Castration-Resistant Prostate Cancer Initiating Enzalutamide vs. Abiraterone
- P104: Reported Patient and Public Involvement in Randomized Controlled Trials in Major Medical Journals and their Protocols
- P105: GeDI System: A Novel Snapshot of Gender Literacy in PrEP Clinical Trials from 2014 - 2025
- P106: Impact of Global Regulatory Frameworks on Antimicrobial Clinical Trials: Design, Timelines, and Approval Outcomes
- P107: "Regulatory Frameworks and Clinical Trial Advances in Gene Therapy for Retinal Degenerations"
- P108: Had the Design Quality of Acupotomy RCTs Improved Over the Past 21 years? -CONSORT-based Literature Study from 2003 to 2024
- P109: Wearables as Digital Endpoints: Real-World Case Studies and Regulatory Challenges in Clinical Research
- P110: Expanded Utilization Metrics for COPD Value Assessment: A Scoping Review and Proposed Framework Using Claims Data
- P111: Real-World Healthcare Resource Utilization by Older Adults with RSV: A Retrospective Claims Analysis
- P112: Navigating Disease Nomenclature Changes: Trends and Gaps in NAFLD/NASH-Related Hepatocellular Carcinoma Research
- P113: Comparative Analysis of Play-Doh and Super Flex Bolus as Tissue-Equivalent Materials in Radiation Therapy
- P114: Silicon Micropillar-Enhanced CRISPR Biosensor for Rapid and Sensitive Detection of Drug-Resistant Bacteria
- P115: CRISPR/Cas9 Gene Editing: Precision Medicine for Obesity Therapeutics Systematic Review
- P116: An Assessment of Real-World Evidence on the Impact of Pharmacogenomic Biomarker CYP2D6: A Systematic Review
- P117: Regulatory Landscape of Accelerated Approval Pathways for Medical Devices in the US and EU
- P118: ReguVisionTM: Revolutionizing Drug Development by Charting FDA-Facilitated Pathways through Multidimensional Mapping
- P119: Assessment of Good Review Practices at the FDA Ghana as it Strives to Become a WHO Listed Agency
- P120: Evaluation of Quality Decision Making Practices used in the Approval of Medicines by Zambia Medicines Regulatory Authority
- P121: Assessing the Age-Appropriateness of Pediatric Medicines
- P122: Racial/Ethnic Disparities in Antihypertensive Medication Use and Its Causal Effect on Dementia Risk: A Longitudinal Study
- P123: Meta-Analysis on Aggregate Data and Individual Patient Data Using R
- P124: The Sulfur Microbial Diet and Risk of Type 2 Diabetes: A Prospective Gene-diet Study from the UK Biobank
- P125: Robust Method for Longitudinal Data via Modeling Sequential Correlation
Professional
- P201: Safety Signaling Industry Benchmarking
- P202: Characterization of Newly Identified Safety Signals for Marketed Drugs by the US Food and Drug Administration, 2020-2024
- P203: Evidence-based Design of Prescription Medication Information: An Updated Scoping Review
- P204: Automating Pharmacovigilance Workflows through AI to Improve Patient Safety Outcomes
- P205: Early Severe Adverse Event Warning Mechanism
- P206: Evaluation of Different Search Strategies to Identify Cases of Anaphylaxis in the FDA Adverse Event Reporting System
- P207: Implementing a Structured Benefit-Risk Assessment (SBRA) Framework: A Case Study
- P208: Quantitative Signal Detection for Small and Specialized Safety Database
- P209: Development of a Safety Toolkit to Influence Inclusion Barriers for Adolescents and Young Adults in Adult Clinical Trials
- P210: Enhancing Inspection Readiness: Best Practices for Pharmacovigilance Teams
- P211: AI Automating Multimodal Evidence Integration for Drug Safety Signal Causality Assessment
- P212: Effective Communication of Drug Benefit-Risk Profiles through Automation for High-Quality Regulatory Documentation
- P213: Standardizing Global Post-Marketing Safety Monitoring Programs: A Unified Approach at Merck & Co., Inc., Rahway, NJ, USA
- P214: Transforming Pharmacovigilance with AI: Revolutionizing Safety Monitoring for Better Patient Outcomes
- P215: A Two-Year Review of Adverse Drug Events (ADEs) in Saudi Arabia: Trends and Pharmacovigilance Insights from 2023-2024
- P216: Use of HLA-B*58:01 Genotyping to Prevent Allopurinol-Induced Severe Cutaneous Adverse Reactions in Korea
- P217: A Review of the Potential Risks of Pancreatic Carcinoma associated with the use of Semaglutide
- P218: Regional Pharmacovigilance Centers: A Cornerstone of Drug Safety Information Development in Korea
- P219: Bayesian Confidence Propagation Neural Network for Signal Detection: Comparing Traditional Disproportionality Methods
- P220: REMS Compliance Program Inspections (FY2019-2023)
- P221: Patient and Prescriber Engagement in Recombinant ADAMTS13 Additional Risk Minimization Measures (aRMM)
- P222: Consumer Perspectives on Post-marketing Drug Surveillance in Brazil
- P223: Characterization of Drugs with REMS Elements to Assure Safe Use (ETASU)
- P224: Assessment of Risk Factors for Myocarditis in the United States Using Integrated Electronic Health Records and Claims Data
- P225: MM120 Demonstrates No Evidence of Abuse Potential in Rodent Preclinical Studies
- P226: Safety Profile of SARS-CoV-2 RNA Vaccines based on Adverse Event Reports in Japan
- P227: Signal Management (SM) Activities using Real-World Evidence (RWE)
- P228: In AI Do We Trust: Workforce Perspectives on AI Readiness and Integration in Clinical Trials
- P229: Patient-Centered Design for Device Risk Communication in Informed Consents: A User Testing Validation Study
- P230: Supporting Quality, Relevance, and Reliability Upon EHR-Sourced Data Accrual
- P231: Sustainable Clinical Trials: Advancing Health Equity and Environmental Stewardship
- P232: Leveraging Oncology Innovations for Advancements in Neurology, Infectious Disease, Rare Disease Clinical Trials and Research
- P233: Comparison of Clinical Trial Recruitment to Incidence and Prevalence of Disease in Certain Demographic Populations
- P234: Automating Document Review and Content Generation to Accelerate Clinical Trial Operations and Stakeholder Engagement
- P235: Advancing Drug Development for Rare Diseases: An Update on the Rare Disease Clinical Outcome Assessment Consortium
- P236: Risk-Based Quality Management in Rare Disease Trials: An Observational Perspective on Data Integrity
- P237: Full Circle: Capabilities Enabling end-to-end Trial Patient&Site Engagement Positively Impact Patient & Site Trial Experience
- P238: Does a Dedicated Research Language Services Team Increase Enrollment and Retention of Spanish Speaking Participants?
- P239: Learned Lessons from a US-wide outreach program to expand enrollment to the decentralized PROMISE Registry
- P240: Ensuring Success in MRCTs with Optimal Sample Sizes for Global Drug Development
- P241: Integrating RBQM (Risk Based Quality Management) into CRF (Case Report Form) Design
- P242: Impact of ICH E6(R3) on Data Managers: Changes in Risk-Based Quality Management for Clinical Trials
- P243: Leveraging Remote Data Capture to Generate Real-World Evidence for Clinical Transformation
- P244: Building a Holistic Patient View Through High Quality Source Data Collection and Linkage
- P245: A Generative AI Tool for Searching and Generating Responses to Regulatory Authority Inquiries on Clinical Trial Notifications
- P246: Creating a Framework for Developing Fit-For-Purpose Studies that Can Support Coverage
- P247: Streamlining Change Impact Assessment with Digital Workflow Solutions
- P248: Automated Extraction of Chemistry, Manufacturing, and Controls (CMC) Change Information from Unstructured Reports
- P249: Multimodal Digital Remote Patient Monitoring (RPM): The Development of Solutions for Adverse Events of Special Interest
- P250: Innovations in Therapy Development for Rare Diseases through the Rare Disease Cures Accelerator –Data and Analytics Platform
- P251: Digital Adoption Platforms: Enhancing Compliance, Data Integrity, and Efficiency in Life Sciences
- P252: Assessing the Impact of Quality Issues on Vocabulary Mappings in Downstream Data
- P253: The Impact of Data Standards and Digital Data Flow (DDF) on Operational Efficiency
- P254: AI-Driven Solutions for Effective Protocol Deviation Management
- P255: Revolutionizing Computer System Validation (CSV) with Artificial Intelligence: A Risk-Based Approach for Quality Assurance
- P300: Harnessing the Power of Generative AI in Medical Writing: Insights from Alexion Medical Writing’s Strategic Thinking Workshop
- P301: Transforming Medical Affairs: The Role of GenAI Vision Models in Streamlined Reference Verification for Promotional Review
- P302: Impact of Publication Extenders: Findings from Dermatology and Oncology Journals
- P303: Artificial Intelligence (AI) Use Cases for Scientific Communications & Medical Information
- P304: The Future of Investigator’s Brochure: Best Practices for Evolving Regulatory Requirements
- P305: FDA’s Proactive Inclusion of PRO-CTCAE, an Exploratory Measure, in an Oncology Drug Label: Opportunity or Risk for Industry?
- P306: Perceptions of the Benefits and Risks of Novel Therapies for Type 1 Diabetes: A Qualitative Study
- P307: Public Access to Clinical Trial Information: A Usability Comparison of Korea and the U.S
- P308: Development of a Patient Centricity Organizational Health Index at a Global Med-Tech Company
- P309: Supply Chain Under Stress: A Data-Driven Analysis of Vulnerable Medicines
- P310: Evolution of a Bioethics Oversight Program in the Healthcare Industry
- P311: 3-Step Process for Making High-Quality Drug Development Decisions Quickly
- P312: Navigating New Frontiers: Next Generation Clinical Trial Quality Assurance Using Advanced Analytics
- P313: Total Kidney Volume as a Prognostic Biomarker: A Use Case for a Regulatory Science Framework of Drug Development Tools
- P314: Accelerating EU IDMP Data Migration: AI-Powered Risk Mitigation Strategies for Improved Compliance
- P315: Investigating REMS Burden: What Are the Opportunities for Standardization?
- P316: Characterizing Regulatory Acceptance of External Control Arms by US FDA and EMA in Oncology
- P317: A Proposed Improved Model for the East African Community Medicines Regulatory Harmonisation Joint Review Process
- P318: Exploring the Impact of Regulatory Convergence to Patients: Japan’s Case for Participating in FDA’s Project Orbis
- P319: The Universal Methodology for Benefit-Risk Assessment (UMBRA): Testing Its Implementation in a South African agency
- P320: RAPS 2024 Global Compensation and Scope of Practice Study for the Healthcare Regulatory Profession
- P321: Proposed Areas of International Harmonization of Real-World Evidence Standards Among Medical Product Regulators
- P322: The Impact of Ethnic Differences Between Eastern and Western Populations on New Drug Applications in Taiwan: A Pharmacokinetic Perspective
- P323: Beyond REMS: A Real-World Data and Community Surveillance Approach to Adaptive Opioid Regulation
- P325: Analysis of Drug Development Trends in Japan for FDA Accelerated Approvals
- P326: Institutional Biosafety Committee Oversight of Clinical Trial Research: Data and Best Practices from a Central IBC Provider
- P329: An AI-enabled Analysis of the Influence of Regulatory Commenting on FDA’s Real World Data/Real World Evidence Guidances
- P330: Using Real-World Data in Claim Expansion of a Direct Molecular Test for Detecting SARS-CoV-2 in Asymptomatic Individuals
- P331: Retrospective Implications Analysis of Geographic Representation in Pivotal Studies: Post-Market Analysis
- P332: Observations following Implementation of Accelerated Approval Pathway for New Drugs in Taiwan
- P333: Responses of Pharmaceutical Companies to Literature Review Inquiries from a Regulatory Authority: A Retrospective Analysis
- P334: A Decade of GCP Inspection in Malaysia: An Analysis of Findings from Trial Sites, Sponsors/CROs & Phase 1 Units
- P335: Applying Agile in a Regulated Setting: Balancing Flexibility and Compliance
- P336: Overview of the Latest Japanese Regulation Reforms and Acceleration in Clinical Development of Orphan and Innovative Drugs
- P337: Insights and Experiences in eCTD v4.0 Implementation: How a Japanese Pharmaceutical Company Achieved eCTD v4.0 Submissions?
- P338: Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
- P339: Automating CMC Dossier Creation from End-to-End with automated Data to Content
- P340: Leveraging Generative and Conversational AI to Simplify and Interpret Complex Regulatory Guidance for Improved Compliance
- P341: Comparing Static and Dynamic Bayesian Borrowing Approaches to Parametric Survival Models Informed by Historical Control Data
- P342: Comparing Correlation Accuracy on Skewed vs Centered Data: Practical Guidelines for Evaluating Clinical Outcome Assessments
- P343: Meta-analysis of Observational Studies in Rare Diseases
- P344: Broad Consent in Clinical Trials: Ethical Implications for Secondary Use of Data
- P345: FDA’s CDER Accelerating Rare disease Cures (ARC) Program: Education, Innovation & Collaboration