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10:45am • Risk-Based Monitoring in Clinical Trials: A Four Year Analysis
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10:45am • What’s in the Future for Global Advancements in Patient Engagement and Patient-Focused Medical Product Development?
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10:45am • New Alternative Methods-Only IND Application: Distant Dream or Immediate Possibility?
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10:45am • Diversity and Inclusion Implications for Global Regulatory
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10:45am • Negotiating your Next Offer
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10:45am • Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Clinical Trial Digital Transformation
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10:45am • Artificial Intelligence: Delivering on the Promise
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10:45am • E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards in Clinical Trials and NDA/BLA Submissions to FDA
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10:45am • ICH E6 R3 Forum: Highlights of What's new and What Changed Regarding Sponsor Responsibilities
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10:45am • Sponsor-CRO Collaborations and the Impact of Decentralized Clinical Trials
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10:45am • Cell and Gene Therapies Pulse Check
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10:45am • Applying Implementation Science Methods to Generate Evidence to Improve Access to New Therapeutics: What has Been Learned?
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1:30pm • International Collaboration for Pharmaceutical Quality and Manufacturing Agility
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1:30pm • Combating Misinformation with Authoratative Medical Product Information
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1:30pm • Enhancing the Quality of Safety Data Collection
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1:30pm • Can We Further Innovate Clinical Trial Designs? Lessons Learned and Future Opportunities
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1:30pm • Consent is the Oil of Customer Engagement: How to Keep the Omnichannel Engine Running
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1:30pm • WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening
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1:30pm • Do Surrogate Endpoints Expedite or Hinder Payer Coverage of Drugs?
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1:30pm • Advances in Real-World Evidence: Randomized Clinical Trials Duplicate, Publication Scandal, and China’s Real-World Evidence Heaven
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1:30pm • Novel Biomarkers and Surrogate Endpoints in a Rare Disease
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1:30pm • Building Trust: Data Privacy in Decentralized Clinical Trials
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1:30pm • Patient Involvement Optimizes Clinical Protocol Design: Real-World Experiences and Insights
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1:30pm • Contemporary Challenges in Personalized Medicine and Companion Diagnostics
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1:30pm • Unleashing the Fearless Quality Professional
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1:30pm • Innovative Digital Health Technologies: Strategies for Successful Integrations, Quality, and Compliance
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1:30pm • Patient-Reported Outcome Measures to Support Oncology Clinical Development and Labeling: Responding to FDA’s Draft Guidance
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4:15pm • What's Next in Precision Medicine? Translational Strategies for Dose Optimization in the Age of Project Optimus
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4:15pm • Creating your Career Plan 101: A Practical Workshop
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4:15pm • Regulatory Cooperation, Coordination, and Reliance in Times of Crisis: The ICMRA Role
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4:15pm • Digital Endpoint Qualifications in Clinical Trials: Collaborations and Applications
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4:15pm • Utilizing Wearable Biosensors to Better Manage Patient Safety During Immuno-Oncology Studies
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4:15pm • The True Decentralization of Clinical Trials: Benefits and Drawbacks of Blockchain Technology
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4:15pm • Enabling the Use of Randomized Pragmatic Studies to Generate High Quality Real-World Evidence for Regulatory Decisions
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4:15pm • How to Assess and Implement Patient Preferences in Decision-Making Along the Medical Product Life Cycle?
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4:15pm • The Promise of Vaccine Platforms to Advance Regulatory Science: Where are we Now, Where are we Going, and How do we get There?
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4:15pm • One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients
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4:15pm • What Patients and Care Partners are Saying about Hybrid and Decentralized Trials
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4:15pm • Supporting Providers in Value-Based Contracts: Machine Learning and Recursive Neural Networks for Outcomes and Treatment Journey Optimization
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4:15pm • Emerging Therapies and Technologies and Leveraging Opportunities for Engaging with Medicine Regulators to Support Innovation
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4:15pm • Best Practices in Effective Gathering of Medical Information Industry Insights
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4:15pm • Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence
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8:30am • Innovation Across Medical Affairs Throughout the Global Pandemic
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8:30am • ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange
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8:30am • Ethical Considerations for Conducting Research During Times of Disruption
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8:30am • Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed?
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8:30am • Innovating Patient Recruitment Through Pharmacy Channels
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8:30am • Leveraging Analytics, Visualizations, and Decision Science to Drive Strategic Decision Making
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8:30am • International Regulatory Convergence and Collaboration
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8:30am • Office of Generic Drugs/Office of Pharmaceutical Quality Town Hall
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8:30am • The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives
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8:30am • Illuminating Risk Minimization Effectiveness Measurement
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10:30am • A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines
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10:30am • Disrupting the Status Quo: Best Practices for Bringing Together Patients and Medical Staff to Positively Impact Trial Diversity
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10:30am • The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) Collaboratory: Facilitation of Medical Product Development for Rare Diseases
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10:30am • Medical Storytelling Inserted Into All Aspects of Medical Affairs
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10:30am • Is Mark Cuban Really Solving the Drug Pricing Problem?
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10:30am • IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Quality Analytics Use Cases and Early Health Authority Feedback
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10:30am • Good Recruitment Practice Under Regulation (EU) No 536/2014
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10:30am • The Future of Regulatory Submissions: Opportunities and Challenges
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10:30am • Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report
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10:30am • ANVISA Townhall
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10:30am • International Harmonization of Real-World Data/Real-World Evidence Use and Acceptance by Health Authorities: Time to Make it Right!
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10:30am • Patient Experience Data in the Label: Closing the Loop
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10:30am • The Full Picture: Innovative Software Tools for Data Insight Generation
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10:30am • Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment
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1:15pm • Getting Things Done in Drug Development Using Agile Practices
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1:15pm • Quality in the Real World: Diagnosing and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data
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1:15pm • Using Artificial Intelligence to Illuminate Predictive Relationships and Discover Biomarkers from Clinical, Molecular, and Digital Data
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1:15pm • Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape
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1:15pm • Pharmacovigilance: Regulator's Perspectives on Quality Approaches to Additional Risk-Minimization Measures and Post-Pandemic Inspection Reflections
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1:15pm • Novel Methods for Signal Identification for Medicines and Medical Devices
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1:15pm • Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions
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1:15pm • Demystifying the Common Legal Agreements, Key Terms, and Pitfalls for Non-Legal Professionals
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1:15pm • Measuring Impact of Patient Engagement Across Research and Development
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1:15pm • Asia Town Hall
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1:15pm • Tech-Enabled Narratives: Technology Meets Process FTW (For the Win!)
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1:15pm • One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot!
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1:15pm • Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives
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1:15pm • The Inflation Reduction Act Price Setting: What are the Impacts on Biopharmaceutical Innovation from Different Perspectives?
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1:15pm • Hot off the Press: Site Challenges and Solutions in Workforce and Technology
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4:00pm • Quality Aspects of FY23-28 User Fee Agreements
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4:00pm • Patient-Preferences and Multistate Models to Enhance Patient-Focus of Traditional Endpoints in Oncology
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4:00pm • Smarter Approaches to Pharmacovigilance Challenges
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4:00pm • SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data
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4:00pm • Can Pragmatic Trials Simultaneously Meet the Needs of Regulators, Payers and Clinical Care?
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4:00pm • Data Analytics for Quality Assurance: Shifting the Paradigm from Issue Detection to Quality Evidence Generation
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4:00pm • PMDA Town Hall
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4:00pm • The Many Faces of In-Trial Interviews: Navigating Operational and Scientific Waters to Optimize Value for Clinical Trials
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4:00pm • Globally Accelerating the Drive to eLabeling for All
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4:00pm • Improving Patient Access with Real-World Evidence: A Framework for Coverage and Formulary Decisions
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4:00pm • IDMP and Data Harmonization Methods: How Your Company will be Impacted
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4:00pm • An Assessment of the Challenges Associated with Cell and Gene Therapies: Are Digital Health Technologies the Way Forward?
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4:00pm • Negotiating your Way Through the Vigilance Agreement Maze: Is There a Better Way?
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4:00pm • Generating Patient Insights to Inform Health Policy Issues: Policy Patient Engagement Research Councils (PERCs)
