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Professional & Student Poster Presentations
Student
- P100: Dual Role of Mirtazapine in Managing Depression & Nause in Cancer Patients on Chemotherapy: A prospective Observational Study
- P101: Advancing Dermatology with Skin Equivalents and Organoids in Pathophysiology and Drug Testing
- P102: From Site-Centric to Patient-Centric? Measuring Inclusion in Decentralized Trials
- P103: Navigating Legal Landscape for Operationalizing Site Specific Acceptance Testing of FDA Authorized AI Medical Devices
- P104: A Systematic Review on the Use of Artificial Intelligence in Pharmaceutical and Medical Device Regulatory Affairs
- P106: MOUD Exacerbates the Distinctive Metabolic Patterns Associated with HIV Infection and Suppressive ART
- P107: Assessment of Compliance with Good Review Practices by Scientific Reviewers within the Zambia Medicines Regulatory Authority
- P108: Barriers to Regulatory Approval: Insights from Recently Released FDA Complete Response Letters
- P109/P110: Evaluating a Continental Pilot for Medicines Listing in Africa: Lessons for Reliance and Efficiency as well as AMA Readiness
- P111: Regulatory and Developmental Trends in ADHD Drug Development: Lessons from Centanafadine and Gaps in Female Representation
- P112: The Digital Policy Architect: A Global Harmonization Framework for AI-Augmented Compliance in Post-Market Surveillance
- P113: XAI-RegSci Index: A Five-Axis Framework for Quantitative Evaluation of Explainable AI in Regulatory Science
- P114: Navigating Value Misalignment and Boundary Work in China’s CGT Ecosystem: A Multi-Stakeholder Qualitative Analysis
- P115: The Multimorbidity Pivot: Aligning FDA and EMA Frameworks for Geroscience-Based Therapeutics
- P116: Analysis of FDA Warning Letters (2020–2025): Recurring CAPA Failures Under QSR and Implications for QMSR Transition
- P117: Gaps in IRB Oversight and Ethical Compliance: A Case Study from a University-Based Human Subjects Research
- P118: Sample Size Considerations in Biosimilar Pharmacokinetic Studies: A Systematic Review
- P120: Impact of Telehealth on Glycemic Control and Healthcare Utilization in Patients with Diabetes
Professional
- P200: Driving Continuous Improvement in Structured Benefit-Risk Assessment (SBRA): Insights from Early Rollout
- P201: Addressing Access Disparities From a REMS Lens: A Qualitative Analysis of the SPRAVATO, TYSABRI, and iPLEDGE REMS Programs
- P202: Early Recognition of Potential Adverse Drug Reactions through LLM Assessment of the Scientific Conference literature
- P203: Mixed Amphetamine Salts (MAS) Generic Drug Switching Trends: An Analysis of 2020 to 2023 U.S. Prescription Volume
- P204: Heart Failure Risk of Guideline-Recommended Pharmacotherapies Versus Gabapentin in Painful Diabetic Neuropathy: A Nationwide Cohort Study
- P205: Evaluating MedDRA Query Approaches for Anaphylaxis Case Retrieval in the FDA Adverse Event Monitoring System (AEMS)
- P207: **Signal Detection Methodology Across Small, Mid Size, and Large Pharmaceutical Organizations
- P208: Cross-Functional Best Practices to Improve Signal Detection in Special-Case Scenarios
- P209: Introduction to Personalized ADR History Notification System in Korea for Preventing Re-exposure to Culprit Drugs
- P210: Risk Management Insights for Oral HIV-1 PrEP: Findings from Two-Wave Knowledge Surveys of Canadian PrEP Prescribers and Users
- P211: Integrating Toxicological and Economic Evidence to Optimize Rare Disease Drug Repurposing
- P212: AI-Driven Pharmacovigilance: A Longitudinal Analysis of Improved Patient Safety and Operational Excellence
- P213: Future Fit Pharmacovigilance - Deploying AI and ML Under Regulated Environment
- P214: Global Trends in Expanded Access: Real-World Operational Insights (2022–2025)
- P215: From Exclusion to Inclusion, a 10-year Analysis of Language Barriers in Clinical Trial Diversity - An IRB Perspective
- P216: Co-Creating a Pediatric Assent Form: Integrating Advisory Board Insights to Improve Clarity and Engagement
- P217: Overcoming Population Constraints: Regulatory-Led Digital Recruitment Innovation
- P218: Decentralized Clinical Trials: Regulatory Development and Current Practice
- P219: Innovative Clinical Trial Designs in Japanese Regulatory Practice: Findings from PMDA Consultations and New Drug Review
- P220: Formal Verification as Regulatory Validation for AI Across the Clinical Trial Lifecycle
- P221: Demystifying Legal Language: Co-Creating Clear Data Privacy and Withdrawal Language for Informed Consent
- P222: Standardizing Site Documentation to Streamline Clinical Trial Operations in Japan
- P223: Correlation of Objective Response Rate (ORR) and Overall Survival Hazard Ratio (OS HR) with Immunotherapy in Cancer Patients
- P224: From PDF to Computable Protocol: Operationalizing ICH M11 for Automated EHR Extraction and Data Provenance
- P225: Successful Implementation of a Fully Remote Participation Option in the Phase 3 Pivotal GLISTEN Study
- P226: AI as an Enabler: Reducing Human Error in eCOA Localization Without Replacing Linguistic Expertise
- P228: eCTD 4.0: A New eRA for Regulatory Submissions
- P229: From Data Quality to Trusted Regulatory Submissions: Enabling CBRS, Global Dossiers, and Faster Approvals
- P230: Leveraging Generative AI and FHIR Standards for Seamless Data Integration and Real-Time Analytics in Clinical Trials
- P231: Novel Asynchronous Qualitative Interview System to Enhance Content Validity Evidence for THRIVE-20-PF in Oncology
- P232: Participant Compliance with an Electronic Parkinson’s Disease Home Diary Measuring Motor Fluctuations and Dyskinesia
- P233: Enhancing Clinical Trial Oversight Using AI-Driven Automated Insights
- P234: Comparative Validation of the Article Screener Agent of an Agentic AI Literature Review Platform Against Manual Review
- P235: GenAI-assisted Clinical Study Report Writing with Structured Content Authoring: Aligning Model Strengths to Section Needs
- P236: Hierarchical Deep Learning for Proactive Safety Signal Detection in Pharmacovigilance
- P237: An Agentic AI Fidelity Evaluation Framework for Real-World Evidence Workflows
- P238: Harnessing Advanced Analytics: Automation of PBRER Summaries to Elevate Analytical Rigor and Decision-Making
- P239: Leveraging AI Agents for Clinical Development Knowledge Management and Utilization
- P240: Emerging Patient Safety Considerations for LLM Based Adverse Event Detection
- P241: A Human+AI Process for Generating Fully-Annotated, Plain-Language Trial Summaries from Source Materials in Under 24 Hours
- P242: Anticipatory Writing as a Catalyst for Patient-Centered Clinical Documentation
- P243: Transforming Medical Review in Clinical Trials Through AI-Enabled Data Workflow Automation
- P244: Governing the Autonomous Pharma: A Framework for Agentic AI Compliance Across FDA, EU AI Act, and MLR/PRC Operations
- P246: Transforming into a New Era of Medical Information: Mobile Journalism, Short Videos, and AI-Assisted Insights and Writing
- P247: Applicability of FDA DTC Advertising Standards to Digital Media: An Enforcement Review
- P248: Copyright Compliance in Artificial Intelligence (AI)-Assisted Medical Information (MI) Content Generation
- P249: Optimizing Medical Information Performance: Evaluating Key Performance Indicators and Future Trends
- P251: Engagement with FDA’s Advancing Real-World Evidence (RWE) Program: Insights from the First Six Cycles
- P300: Advancing Precision Medicine and Drug Development: The Landscape of FDA Approvals for Companion Diagnostics
- P301: FDA Biomarker Qualification Program: Analysis of Review Issues Underpinning Qualification Success Factors and Lessons Learned
- P302: Postmarketing Commitments for Companion Diagnostic Development in Oncology Drug Approvals (2012–2025)
- P303: Evolution of a Bioethics Oversight Program in the Healthcare Industry
- P304: Publication Planning as a Life Science Startup Strategic Capability
- P305: Utilization of Artificial Intelligence (AI) by African Regulators for Risk-Based Assessment of CMC: Proof of Concept
- P306: Analysis and Evaluation of 2024 Drug Defect Reports in Taiwan
- P307: Promoting Innovative Strategies in Asia for Addressing Drug Supply Shortages
- P308: Inspection Readiness by Design: Embedding Quality and Compliance into Daily Site Operations Using Flexible FSP Support
- P309: ePI for Prescription Medicines: A Review of Challenges and Opportunities Across International Markets
- P310: Drug Shortages Final Rule Retrospective Analysis
- P311: Strategic Insights into Evidence and Benefit-Risk Expectations of Health Authorities
- P312: AI-Enabled Multi-Framework Regulatory and Quality Gap Detection for Pharmaceutical Operations Across the Product Lifecycle
- P313: Policy Opportunities to Advance Rare Disease Innovation
- P314: Single-Patient Expanded Access Programs: Data and Best Practices from a Central IRB
- P315: Perceptions of Integrating Patient Preference Information into Regulatory Decision-Making: A Multi-Stakeholder Survey
- P316: Evolving Trends in the Use of Clinical Outcome Assessments in FDA and EU Health Technology Agency Decisions
- P317: Comparative Analysis of Drug Facilitated Regulatory Pathways and Review Outcomes among the USFDA, EMA, and Taiwan FDA
- P318: System Theoretic Process Analysis: Identifying Risks of the Regulatory Reliance Ecosystem
- P319: Bridging Study Evaluation and Regulatory Pathways for New Drug Applications: Addressing Ethnic Factors in Taiwan
- P320: Data Curation Best Practices and Innovations for Real World Evidence Generated Using Electronic Health Record Sourced Data
- P323: Accelerating Global Regulatory Approvals: Lessons from ORBIS and Non-ORBIS Submission Strategies
- P324: Glutamate Dehydrogenase (GLDH) as a Safety Biomarker: Applying a Regulatory Science Framework for Drug Development Tools
- P325: Proposed Areas of International Harmonization of Real-World Evidence Standards Among Medical Product Regulators
- P326: Beyond Harmonization: Visualizing Regulatory Gaps in the Product Lifecycle for Global Simultaneous Submission and Approval
- P327: Japan’s Evolving Regulatory Environment: Attracting Overseas Pharmaceutical Innovation with Reducing Barriers
- P328: Stakeholder Perspectives on Malaysia’s New Regulation: Transitioning from Guidelines to Clinical Trial Legislation
- P329: Tracking Digital Health Technologies (DHTs) in IND, NDA, and BLA Submissions: A CDER Case Study
- P330: U.S. Patient Enrollment Across Oncology Multi-Regional Clinical Trials Supporting Initial BLA and NDAs
- P331: Mapping bioequivalence (BE) recommendations in product-specific guidances (PSGs) for polymeric long-acting injectables (LAI)
- P332/P333: Advancing Post-Market Approval through Global Collaboration: Evidence from Taiwan
- P334: Practical Framework for Integrated Risk Management in Pharmaceutical R&D
- P335: GCP Compliance Challenges Stem From Training Gaps in Clinical Research Practices
- P336: Vaccination-Era Serial Intervals Enhance Real-World Surveillance and Forecasting During a US Measles Outbreak
- P337: FDA Post-Marketing Pregnancy Study Requirements: Evaluating Study Reporting and Label Integration
- P338: Applying Target Trial Emulation to Natural History Studies for Regulatory Decision Making in Biomarker-Defined Oncology
- P339: Estimand Framework in Phase 1b Autologous CAR T-cell Therapy for SLE
- P340: Integrating Patient-Reported Outcomes and Electronic Health Records Data for Innovative Real-World Evidence Generation
- P341: Characterization of Submissions with Real-World Evidence to FDA’s Center for Drug Evaluation and Research, Fiscal Year 2025
- P342: Machine Learning–Derived RWE for Scientifically Appropriate and Statistical Sound Promotional Materials: A Case Study
- P344: Privacy-Preserving Federated Analysis Enables International Rare Disease Evidence Generation
- P345: Regulatory Considerations in Pediatric Formulation Development for Tropical Diseases on the Example of Emodepside