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Professional & Student Poster Presentations
Professional
- P100: A Mixed Methods Study of Real World Use of a Machine Learning Application for Coding Adverse Events in Clinical Trials
- P101: Transforming Traditional SOPs and Creating Job Aids to Improve Consistency and Enhance Regulatory Compliance
- P102: Process Improvements in Pharmacovigilance Corrective and Preventive Action Management
- P103: Risk Prediction Models for Cardiotoxicity of Antineoplastic Agents for Breast Cancer: A Systematic Review
- P104: Physician Perspectives on Biosimilar Substitution and Reimbursement Practices
- P105: A Post-Authorization Safety Study of the Effectiveness of Additional Risk Minimization Measures for Luspatercept: Challenges
- P106: Exploring the Role of Federal and Sponsor Expectations in Diverse Recruitment Practices: Implications for Stakeholders
- P107: Making an Inclusive Impact: Collecting Sexual Orientation and Gender Identity Demography in Clinical Trials
- P108: A Targeted Literature Review Exploring Solutions for Inclusivity of Transgender and Non-Binary Patients in Clinical Research
- P109: Association Between Operational Complexity of Clinical Trials and Average Database Lock Time During Mid-Study Updates
- P110: Establishing a Hybrid Control in Conjunctival Allergen Challenge Studies for Allergic Conjunctivitis
- P111: Using a Quality Improvement Collaborative Methodology to Improve Pediatric Research Site Processes
- P112: EMR to EDC Solution Improves Efficiencies of Clinical Research Studies
- P113: Determining the Proper Target Ranges for Race and Ethnicity Representation in Clinical Trials
- P114: Utilizing Project Management Software (Smartsheet®) to Capture, Centralize and Communicate Publication Activities
- P115: “The Power of Particles”: A New Online Portal to Showcase the Benefits of Nanomedicines
- P116: Engaging in Online Communities is Associated with Improvements in Patient Activation
- P117: Quality and Reliability of Machine-Learning Derived Variables in Clinico-Genomic, Real-World Datasets
- P118: Establishment and Benefits of an End-to-End GxP Quality Governance Program Across the Full Product Lifecycle
- P119: Early Insights: Impact of the RACE Act on U.S. Pediatric Oncology Regulatory Strategy
- P120: An Exploratory Meta-Analysis on the Effect Size of FDA-Approved and Not-Approved Anti-Cancer Drugs Over 25 Years
- P121: A Contract Research Organization's (CRO) Experience Serving as a Regulatory Sponsor
- P122: Trends in OPDP Enforcement: Warning and Violation Letters in Two Different Eras
- P123: Relianomics: A Proposed Approach to the Assessment of the Societal, Economic, and Regulatory Impacts of Reliance Pathways
- P124: Not Just Icing: The Importance of Surface Characteristics of Iron-Carbohydrate Nanomedicines
- P125: State Space Models Outperform Moving Averages for Assessing Patient-Reported Quality of Life Over Time
- P126: Discovering Deep Work and a Virtual Productivity Threshold (VPT) Working Remotely in Medical Affairs
- P200: Utilization of the AAPCC National Poison Data System (NPDS) in Pharmacovigilance at U.S. Food and Drug Administration
- P201: Empowering the Next Generation of Potential iDMC Members
- P202: Comparison of Product Information Provided by the EMA and the FDA for the Drugs Acting on the Central Nervous System
- P203: Evaluating Regulatory Assessment of Risk Management Strategies by the EMA and US FDA
- P204: RWE Thought Experiment: Could RWE Have Prevented Today's Opioid Epidemic? Lessons from 19th Century China
- P205: Models for Agile/Decentralized Clinical Trials and Value Drivers Compared to At-Site Studies
- P206: SARS-CoV-2 Viral Levels and Antibody Response in Mildly Symptomatic and Asymptomatic Participants
- P207: The Comparison of BMI Scores Between Japanese and Caucasian Healthy Volunteers in Clinical Trials and its Implications
- P208: New Trends in Biosimilar Clinical Development
- P209: Selection of Spinal Needle Types for Cerebrospinal Fluid Collection in Clinical Trials
- P210: EU CTA Planner (CTAP): A Tool to Plan and Manage EU CTA Submissions and Correspondence in Support of EU CTR 536/2014
- P211: BYOD Versus Provisioned Devices: A Cross-Study Exploration of Factors Influencing Patient Compliance
- P212: AI Under the Hood: What Natural Language Processing (NLP) Means for Pharma -Moderna, Coherus Medical Affairs Use Case
- P213: Impact of COVID-19 on Preventive Care Services Utilization and Medication Adherence in Diabetes Mellitus Patients
- P214: Online Patient Communities as a Novel Patient Engagement Strategy
- P215: The Benefits and Value of a Single Integrated Electronic Quality Management System across the GxP Product Lifecycle
- P216: Comprehensive Quality Strategy (CQS): Driving Quality Excellence to Achieve Product Realization
- P217: Analysis of Orphan Drugs (ODs) in the 21st Century by Type of Orphan, Approval Times and Facilitated Review Pathways (FRPs)
- P218: A Comparison of Instructions for Use (IFU) and Manufacturer Produced Administration Video Consistency for Biologic Products
- P220: Trends in OPDP Consumer Enforcement from 1997 to the Present: The Effect of Marketing Spend
- P221: Physicochemical Characteristics of the Iron-Carbohydrate Complexes, Venofer and an Approved Iron Sucrose Generic
- P222: Development of an Effective Repository of the Company Core Risk Management Strategy
- P223: New Visualization Models of Designation Pathway and Group Categorization of Device-Drug /Biologic Combination Products in US
- P224: Business Continuity Planning in Combating COVID-19 with Resilience: The Way Forward