DIA 2024 Global Annual Meeting

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DIA 2024 Global Annual Meeting

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8:00am PDT

#301: Risk Minimization in the EU: New Guidance, New Collaborations Room 11AB #303: How Common Data Models Can Address the Challenges in the Use of Clinical Trial and Real-World Data for Evidence Generation Room 6D #304: Synergizing Large Language Models and Digital Health Technology for Healthcare Transformation Room 6E #305: All the Ways Medical Affairs Supports Product Development: From Clinical Trials to Product Launch Room 7AB #306: Which Clinical Outcome Assessment to Choose: Questionnaire or Sensor? Time to Align an Endpoint Selection Framework Room 15AB #308: Unlocking Innovation: Implementing Future-Focused Risk-Based Quality Management Quality Briefs - A Cross-Functional Challenge Room 8 #310: WHO Town Hall: Safeguarding Public Health - WHO's Vision for Global Regulatory Excellence Room 1AB #311: Australia, Canada, Singapore, Switzerland, and United Kingdom Consortium (Access): Re-Imagining Regulatory Collaboration Room 6B #307: Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products Room 2 #312: Revolutionizing Regulatory CMC and Advanced Manufacturing with the Power of AI: Unleashing Innovation and Efficiency Room 6C #313: The Future of Women’s Health: Do We Really Want Innovation? Policy Ideas To Advance Innovation, Access, and Novel Approaches Room 5AB

10:00am PDT

#317: Unlocking the Potential of Pharmacogenomics for Reducing the Burden of Adverse Drug Reactions Room 6B #319: Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data Room 5AB #324: Using Data Analytics for Good Pharmacovigilance Practices Room 15AB #318: Defining an Inclusive Clinical Trials Approach in Europe Room 6F #323: Driving Capacity Building, Equity, and Geographic Expansion in Clinical Trials Room 2 #326: Bringing Transformational Treatments to Patients: Regulatory Convergence and Reliance on Cell and Gene Therapy Products Room 6C #322: Leveraging Testing Results Generated Within Treating Hospitals for Trials Across the Globe Room 1AB #328: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products Room 6A #325: A Paradigm Shift in Global Regulatory Reviews: Has the New Normal Arrived? Room 11AB #327: Enabling Innovation and Regulatory Agility to Address Sustainability, Environment, and Climate Goals Room 14AB

11:15am PDT

#331 CH: Emerging Standards for Novel Excipients Content Hub Sails Pav

11:45am PDT

#332 CH: Informing Clinical Trials with Patient Feedback Through Simulations: An Innovative Methodology Content Hub Sails Pav

12:30pm PDT

#333 CH: Real-World Evidence (RWE) for Regulatory and Health Technology Assessment (HTA) Decision Making – Where are we? Content Hub Sails Pav

1:15pm PDT

#344: Leveraging Point of Care Technologies for Near Real Time, Interactive Safety Surveillance: Opportunities and Challenges Room 14AB #348: Challenges and Solutions to Building the Right Patient-Centered Evidence to Support Fit-For-Purpose Sensor-Based Outcomes Room 2 #345: Regulatory Considerations in Trial Design for Cell and Gene Therapies Room 5AB #352: Applying Machine Learning and Artificial intelligence for Predicting Product Profile Approvability (PoPPA) Room 6F #353: ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance Room 16AB #354: ICMRA Post-Pandemic: Regulators Looking into the Future Room 6A #349: Study Design for Cell and Gene Therapy Trials: Regulatory Overview, Challenges, and Updates Room 15AB #347: Artificial Intelligence in the Drug Development Lifecycle: Opportunities and Challenges in Regulatory Operations Room 6B #355: Unlocking the Puzzle of Borrowing Adult Data for Designing Innovative Hybrid Pediatric Trials Room 8

2:30pm PDT

#358 CH: RBQM (Risk-Based Quality Management): What Topics Should be Discussed with Whom in the Room? Content Hub Sails Pav

3:15pm PDT

#359: A Safety Surveillance Plan for Serious Anticipated Events Room 6C #362: Streamlining Processes and Data Exchange Across R&D Functions to Improve Performance and Facilitate Automation Room 11AB #366: The Intersection of Patient-Experience Data and Benefit-Risk Analysis Room 5AB #364: Unlocking Success: Mastering the Pharmaceutical Asset Lifecycle Journey Room 2 #365: Embedding Diversity and Inclusion into Global Clinical Research: Where Have we Been and Where are we Going? Room 6F #367: EMA Town Hall Room 6A #363: Implementing Changes To Drug-Device Combination Products Globally Room 1AB #368: Harnessing the Power of Artificial Intelligence (AI) in Clinical Research From Knowledge Graphs to Generative AI Room 6E #369: Improving Communication Across Differences in Drug Development Teams Room 8

4:30pm PDT

#370: Critical Appraisal of Artificial Intelligence Solutions for Pharmacovigilance Room 6B #374: Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation Room 5AB #372: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence: An Industry and Regulatory Agency Experience Room 6A #373: Patient-Centric Approaches in Summaries and Data Return Room 6D #371: Using Influencers to Recruit Hard-to-Engage Populations Room 7AB #375.1: Middle East Emerging Opportunities Room 6C #375: Sustainability of Rare Disease Drug Development Room 6F #376: Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices Room 6E #377: Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework Room 1AB