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Professional & Student Poster Presentations
Professional
- P100: Biomarkers Used to Support FDA Non-oncologic Rare Disease Drug Approvals Between 2013 and 2022
- P101: FDA’s Approach to Fulfilling PDUFA VII Commitments Related to Use of Digital Health Technologies to Support Drug Development
- P102: Call for Representative Oncology Trials: FDA Racial & Ethnic Diversity Postmarket Requirements Sep 2022 - Aug 2023
- P103: Evaluation of the Economic Impact of Reliance Review: A SAHPRA Case Study
- P104: Protection of Non-subjects in Clinical Trials Involving Human Gene Transfer: Data and Best Practices from a Central IRB
- P105: Assessing the Use of Risk-Based Approaches in Four Major Agencies – What is their Impact on the Approval of New Medicines?
- P106: Understanding of Drug Approval/Disapproval Decisions and Accountability - Development and Results of a Training Program
- P107: ChatGPT: A Reliable Tool to Identify Regulatory Precedents?
- P108: Exploring Regulatory Trends and Precedents with an Internal Database of FDA-Approved Companion Diagnostics (CDx) in Oncology
- P109: Evaluation of PMR/Cs for Assessing Data in Racial and Ethnic Populations Underrepresented in Premarket Clinical Trials
- P110: Risk Evaluation and Mitigation Strategy (REMS) Standardization of Assessment Plan Metrics
- P111: Confirmatory Evidence of Effectiveness Used to Support Non-Oncologic Rare Disease Novel Drug Marketing Application Approvals
- P112: Assessing Feasibility of Using RWD to Support Biosimilar Development: Rituximab use in US Patients with Follicular Lymphoma
- P113: Achieving IDMP Compliance with Digital Regulatory Information Management and SPOR Data Synchronization Solutions
- P114: Improving Patient Subgroup Representation with Real-World Data
- P115: Electronic Product Information (ePI) Pilots Across LATAM: A Sponsor’s Digital Transformation Study
- P116: Biopharmaceutics Evaluation for Approval of Parenteral Formulations: Biowaiver versus Establishing a Clinical Bridge
- P117: Health Canada Regulatory Requirements for Clinical Trials with Cannabis and Psychedelic-Assisted Psychotherapy
- P118: Facilitating the Accessibility of Orphan Drugs: Analysis of Orphan Drug Cases from 2018 to 2023 in Taiwan
- P119: Analysis of Approval Regulations of Colorectal Cancer Drugs in the United States: Twenty-Year Retrospective Study
- P120: Clinical Outcome Assessment (COA) Qualification Program Analysis
- P121: Adapting Real-World Data (RWD) into CDISC Submission Standards: Updates from a Case Study
- P122: Development, Alignment, and Maintenance of Safety-informing Regulatory Documentation
- P123: Regulatory CMC Trends in Bispecific Antibody Development
- P125: Interactive Data Driven Platform for Detecting, Extracting, and Adjudicating Secondary Primary Malignancies in Safety Database
- P126: Impact of Lost to Follow-Up on Power and Study Results in Randomized Controlled Studies with Time-to-Event Endpoints
- P127: Extracting Lab Value Reference Ranges from Real World Neonatal ICU Data
- P128: Statistical Methodology for Safety Study using Real-World Data (RWD)
- P129: Artificial Intelligence/Machine Learning advances in Real World Data Analytics
- P130: Harnessing the Synergistic Effect of Commercial Software and R to Build and Power a Larger Clinical Design Space Exploration
- P131: Associations between Social Determinants of Health and Initiation of Wegovy, Ozempic, and Mounjaro
- P133: Cultivating Global Competencies Through Cross-Cultural Exchange (CCE) Programs for Pharmaceutical Professionals
- P200: Health Equity and Inclusive Research Experts Profiling: Identifying Healthcare Professionals to Address Health Disparities
- P201: Dental Adverse Events with Transmucosal Buprenorphine Used to Treat Opioid Use Disorder and Pain: A Case Series
- P202: Characteristics of Opioid-Induced Hyperalgesia Occurring with Short and Long-Term Opioid Use
- P203: Working with Patient Councils to Mitigate Drug-Related Risks
- P204: Using Historical RCT Controls Cohort to Contextualize Serious Adverse Events for ongoing RCTs
- P205: Comparing Safety Between Generic and Brand Drugs of Statins Marketed in Japan: A Cohort Study
- P206: Comparison of US FDA and EMA Risk Minimization Strategies for Products with Eliminated REMS with ETASU and EU aRMMs
- P207: The Long-Term Safety of Tofacitinib as a Treatment for Moderate-to-Severe Ulcerative Colitis Based on Korean National Data
- P208: A First-in-Human Study Evaluating Safety and Pharmacokinetics in Healthy Participants of the Heavy Metal Chelator HOPO 14-1
- P210: Comprehensive Analysis of Pharmacovigilance Inspection Practices in the Pharmaceutical Industry in Saudi Arabia
- P211: Drug Shortages in Saudi Arabia: A Cross-Sectional Study
- P212: Effectiveness of the Additional Risk Minimization Measures for Luspatercept Among Healthcare Professionals in Europe
- P213: Pioneering Use of a Decentralized Clinical Trial Model Leading to Faster Patient Recruitment in a Rare Cancer Study in Japan
- P214: Leveraging Real-World Data for a Culture of Learning in Health Systems: A Landscape Assessment
- P215: The ACT ON Trial: Assisted Cascade Testing through Outreach and Navigation
- P216: Implementing Clinical Trial to Real-World Data (RWD) Linkage
- P217: EFFECT: An Epidemiological Framework For Equitable Representation of Racial and Ethnic Populations in Clinical Trials
- P218: Pharmacist Training for Advanced Therapeutic use in a First in Human Study (FIH): Delivery of AAV9 CRISPR/Cas9 in Aviremic HIV Participants
- P219: Identifying Novel Endpoints in Rare Disease Studies Using Real-World Evidence: A Regulatory Science Perspective
- P220: Decentralized Clinical Trials Platform Construction for Implementation in Ultra-Rare Cancer Clinical Trial in Japan
- P221: Important Tool in our Rare Disease Toolbox: Hybrid Retrospective-Prospective Natural History Studies as External Comparators
- P222: Innovation in Times of Uncertainty: The OPTIMAL Trials Experience Conducting a Large-Scale Clinical Trial after COVID-19
- P224: Context and Comparative Effectiveness of Covid-19 Treatments: Predicting mortality, Rehospitalization, and Activities of Daily Living (ADLs) Across Covid-19 Variants and Treatments
- P225: Optimizing Site and Country Selection for Clinical Trial Planning: a Mixed Integer Linear Programming Approach
- P227: Clinical Biomarkers: Implementing the Principles of Context-Of-Use for Biomarker Bioanalysis in Support of Drug Development
- P228: Development of Data and Artificial Intelligence (AI) Ethics Principles within a Pharmaceutical and Diagnostics Company
- P229: Using Structured Clinical Trial Information from the National Cancer Institute to Improve Cancer Clinical Trials Search
- P230: The Use of Decentralized Research Technologies for the Continuity of Participant Follow Up during the COVID-19 Pandemic
- P231: Professionals’ Perceptions on Differences Between RCT and EHR Data by Literature Review and on the Use of EHR Data by Survey
- P232: From Dreams to Implementation: The Realities of Incorporating GenAI in Life Sciences and Healthcare
- P233: Journey to the Center of Plain Language Summaries (PLS): A Retrospective analysis of Audience Engagement Measures
- P234: Regulatory Updates: New Therapeutic Possibilities for the Brazilian Population
- P235: Hereditary Transthyretin-Related Amyloidosis Ongoing Clinical Study: A Baseline Report of the First 3,167 Participants
- P238: Optimization of Content Retrieval for Medical Information Scientific Responses by the Addition of Medical Conference Evidence
- P239: Choosing the Right Design: A Guiding Framework for Using Direct-to-Patient, Hybrid and Conventional Site-Based Study Designs
- P240: Taiwan's Pediatric or Rare Severe Disease Priority Review Voucher Program: Enhancing Novel Drug Accessibility
- P242: Update on a Biopharmaceutical Bioethics Consultation Service: 16-Year Descriptive Characteristics
- P243: 14 Day Continuous Purification Process Achieves Acceptable Bioburden and Product Quality
Student
- S100: Risk of Neutropenia with the Use of Ceftaroline: A Review
- S101: Analysis of Quality of Life Patient-Reported Outcomes in Clinical Trials for Huntington’s Disease
- S102: Exploring Risk Factors, Life style modification Unveiling the Comparative Efficacy of Metformin and Glimepiride
- S103: Remaining Hurdles and Potential Solutions in Realizing the Therapeutic Promise of iPSC - An Overview of Patent and Clinical Data
- S104: Comparison of the Regulatory Performance of NMRAs in Africa with WHO Maturity Level-3 Status: Identifying Best Practices
- S105: Evaluation of Good Review Practices in member agencies of the East African Medicines Regulatory Harmonisation Initiative
- S106: Assessment of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Opportunities and Challenges
- S107: Phototoxicity Testing of Emerging Fluorescence Imaging Products: Reactive Oxygen Species Generation and Photocytotoxicity
- S109: Evaluation of Time-To-Event-Endpoints in Oncology Biosimilar Trials
- TBD: Survey on the Mental Health Status of COVID-19 Recovered Patients in Macao: A Cross-Sectional Study