DIA 2024 Global Annual Meeting

Attending this event?

DIA 2024 Global Annual Meeting

9:00am PDT

92F: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop TBD 93F: Leadership Bootcamp TBD

7:00pm PDT

DIA Annual Meeting Networking Reception - USS Midway USS Midway

7:00am PDT

Coffee and Light Refreshments Sails Pavilion

8:00am PDT

#100: Opening Plenary and Keynote Address Ballroom

10:00am PDT

Coffee Break Exhibit Hall Student Case Competition Sails Pavilion

10:15am PDT

#101 IT: Taimei Technology Innovation Theater: Next-Gen Trials Platform: AI-Native, Collaboration-First, and Site Network Exhibit Hall Theater #1 #102 IT: Appian Innovation Theater: AI in Life Sciences - Promise or Peril? Exhibit Hall Theater #2 #103 IT: Mendel AI Innovation Theater: RWD 2.0 - Decoding Patient Journeys at Scale through Clinical AI Exhibit Hall Theater #3

11:00am PDT

#104: Reporting of Pre-Market and Post-Market Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards Room 15AB #108: Risk Management in Advanced Device Technology Development Room 11AB #106: Machine Learning and Simulations to Facilitate Clinical Trials Room 5AB #107: Cloud-Driven Transformation: Empowering Pharma Industry and Regulators Room 6B #105: The Intersection of Science, Ethics, and Participant Collaboration in Pediatric Rare Disease Product Development Room 17AB #109: GCP Renovation: How Will GCP Inspection Change in Europe, Japan, and the US? Room 1AB #110: Modernizing CDER’s New Drugs Review Program (NDRP): A Progress Update Room 6F #111: China Town Hall Room 6D #112: Regulatory Convergence for CMC Requirements: The Challenges and Benefits of a Single Global Dossier Room 6C #113: Master Protocols: Integrating and Debating Clinical Trial Designs Room 2 #114: Breaking Boundaries: Overcoming Policy Crosstalk and Globalization Barriers to Foster Innovation Room 6E #115: From Intention to Action: Building Diversity, Equity, and Inclusion Initiatives to Create a Culture of Belonging Room 8 #116: Navigating the Trusted, Responsible, and Ethical Horizon of Artificial Intelligence: Uniting Healthcare Perspectives Room 6A

12:00pm PDT

#117 CH: Rare Diseases Multistakeholder Collaboration Towards Regulatory Endorsed Innovative Clinical Development Approach Content Hub Sails Pav Luncheon Service Exhibit Hall

12:15pm PDT

#119 IT: RWS Innovation Theater: Accelerate Time-to-Market with Smart, Structured Content, Reuse, and AI Exhibit Hall Theater #1 #120 IT: Datacubed Health Innovation Theater: The Impact of Digital Tools on Pediatric and Elderly Clinical Trials Exhibit Hall Theater #2 #121 IT: Castor Innovation Theater: Practical AI - Creating a Future Without Manual Data Re-Entry Exhibit Hall Theater #3 #118 RT: Roundtable Discussion: The Interaction of Science, Ethics, and Patient Collaboration in Pediatric Rare Disease Product Development TBD #POS 1: Professional and Student Poster Session 1 Posters Exhibit Hall

12:45pm PDT

#122 CH: Digital Transformation: More Than Just Technology - Understanding How to Make it a Reality Content Hub Sails Pav

12:55pm PDT

#123 IT: IQVIA Innovation Theater: Evolving Clinical Development Approach Amidst a Digital Transformation Wave Exhibit Hall Theater #1 #124 IT: PPD, part of Thermo Fisher Scientific Innovation Theater: Accelerating Drug Development Through the Convergence of Real-World Data (RWD) and Technology Exhibit Hall Theater #2 #125 IT: Box Innovation Theater: From Data Chaos to Digital Clarity - Defining the Next Generation of Life Sciences with AI and eSignatures Exhibit Hall Theater #3

1:30pm PDT

#126 CH: AI Enhanced Contact Center: Risks to Consider for Medical and Patient Information Exchange Content Hub Sails Pav

1:35pm PDT

#127 IT: Deloitte Innovation Theater: Turning Vision into Reality - Realizing the Promise of Next-Gen Regulatory Intelligence Exhibit Hall Theater #1 #128 IT: Evernorth Health Services Innovation Theater: Analyzing Online Survey Responsiveness and Participation Exhibit Hall Theater #2 #129 IT: H1 Innovation Theather: Beyond the Numbers - Humanizing Data in Clinical Trials for Inclusive Healthcare Solutions Exhibit Hall Theater #3

2:15pm PDT

#132: The Cost of Moving the Needle on Clinical Trial Representation: Strategies for Diversity Budget Planning and Resourcing Room 5AB #133: ICH M11 Protocol Template: A Global Solution for Global Drug Development Room 17AB #131: Innovative Approaches to the Design of Pediatric Development Programs: What’s New in the Use of Pediatric Extrapolation Room 14AB #134: Shifting Medical Writing Value Propositions with the Use of Technology Tools Room 2 #135: Enhancing the Science of Patient Engagement and Patient Input: What's in the Future? Room 6B #138: Having the End in Mind When Building Quality into Clinical Trials: A Regulatory and Industry Perspective Room 6D #139: Comparative Perspectives on Regulating AI in Drug Development: US Versus EU Room 6C #140: The State of Real-World Evidence for Regulatory Decision-Making: Views from FDA, EMA, and PMDA Room 6F #137: Options to Consider When Balancing Risk, Timelines, Cost, and Patient Centricity While Meeting Project Optimus Guidelines Room 1AB #136: In Vitro Diagnostic/Companion Diagnostics Developments in the US and Impact on Global Programs Room 15AB #141: Innovation in Manufacturing Globally Room 11AB #142: Causal Inference Methodology in Drug Development Room 6E #130: Interactive Safety Graphics in the Regulatory Decision-Making Process Room 6A #143: Unveiling the Secrets of Success: An Executive Panel with Insights to Navigating your Career Journey Room 8

3:30pm PDT

#144: Paradigm Shift in Adverse Event Report Management and Sharing: The Case, The Need, and Possible Ways Forward Room 6C #145: Selective Safety Data Collection: As a Tool to Advance Clinical Trial Designs Room 5AB #147: Data and Technology Influence on ICH Initiatives: M4Q(r2)/Q12 and Global Harmonization Room 6B #148: Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents Room 1AB #149: Effective Patient / Industry Collaboration: Valuing Patient Lived Experience To Inform Trial Design Room 6F #150: Building Trust in New Alternative Methods in Investigational New Drug Applications Room 1AB #152: Innovative Alternative Approaches to Evaluating GCP During the COVID-19 Public Health Emergency and Beyond Room 17AB #153: Designing your Regulatory Intelligence Framework: Powered by Artificial Intelligence and Critical Thinking Room 15AB #154: Impact of Accelerated Pathways on Patients in Five Countries/Regions Room 11AB #155: Health Canada Town Hall Room 6D #146: Past, Present, and Future: How Industry and FDA are Handling the Evolving Clinical Trial Diversity Regulatory Landscape Room 6A #156: Data Insight Generation: Leveraging Data Visualization in Study Planning, Monitoring, Exploration, Reporting, and Submission Room 6E #157: Be Creative and Innovative: A Simple Step-by-Step Process for You and Your Team Room 8 #151: Elevate Leadership: Harnessing the Five Superpowers Room 2

4:45pm PDT

#160 IT: Certara Innovation Theater: Technology-Enabled Writing - Use CoAuthor™ as your Fully Integrated GenAI Medical Writing Platform Exhibit Hall Theater #3

7:00am PDT

Coffee and Light Refreshments Sails Pavilion

8:00am PDT

#201: Considerations for Identification of Drug-Induced Liver Injury Room 6D #202: Behavioral and Educational Strategies for Avoiding Falsified Medicine Exposure (BE SAFE) Room 6A #203: Feasible Site Feasibility Assessments: Rethinking Business as Usual to Reduce Burden, Timelines, and Costs for Sustainability Room 6C #204: Wearable Sensors and Digital Health Technologies for Tracking Neurological and Neuromuscular Disorders Room 5AB #205: Data Standards SOS: Reducing Burnout and Navigating Through Fatigue - Part 1 Room 2 #206: Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making Room 16AB #207: Early Experience with EU In Vitro Diagnostics Regulation: Performance Study Applications Room 1AB #208: Good Data Governance Practices: Regulatory and Industry Perspectives Room 14AB #209: Leveraging New Meeting Opportunities in PDUFA VII: Experiences with Type D and INTERACT Room 11AB #210: Digital Biomarkers as Clinical Endpoints: The Road to Regulatory Acceptability Room 6B #211: PMDA Town Hall Room 15AB #212: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability Room 6F #213: Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications Room 17AB #214: Unlocking Artificial Intelligence's Latest Development: Chat GPT for Beginners Room 8

9:00am PDT

Coffee Break Exhibit Hall

9:15am PDT

#215 IT: Clario Innovation Theater: Responsibly Advancing the Use of Artificial Intelligence (AI) in Clinical Trials - Current Landscape, Common Misconceptions, and Future Opportunities Exhibit Hall Theater #1 #216 IT: Zelta by Merative Innovation Theater: Revolutionizing Research - The Impact of Machine Learning and Automation in eClinical Platforms Exhibit Hall Theater #2 #217 IT: Lokavant Innovation Theater: Prescriptive Study Planning: Optimizing Clinical Trials for Time Efficiency, Cost Savings, and Quality Exhibit Hall Theater #3

10:00am PDT

#218: Long-Term Safety of Approved Medicines: Approaches for Identifying, Characterizing, and Quantifying Delayed Adverse Events Room 6C #219: How to Compare FDA Medical Queries and Standardized MedDRA Queries with Interactive Graphics Room 8 #220: Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases Room 5AB #222: External Control Arms at Scale: Multicenter, Multisource Infrastructure for External Control Arms Room 11AB #223: Challenges in Exceeding the Quality of Existing Endpoints and Approaches Using Digital Tools Room 6B #224: Data Standards SOS: Reducing Burnout and Navigating through Fatigue - Part 2 Room 2 #225: Regulatory Guidance and Papers on Technology Innovations Room 6D #226: Effective Patient Engagement in Patient Experience Data: Practical Insights from Case Studies in Hard-to-Reach Populations Room 15AB #221: Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology Room 6F #227: How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective Room 17AB #228: Access Consortium and Project Orbis: Experiences from Industry and Regulatory Authorities and Recommendations for Improvement Room 16AB #229: Clinical Trial Enrollment Diversity: Why and How to Engage Community Health Centers Room 1AB #230: International Regulatory Convergence: Regulatory Science to Address Challenges Brought by Pharmaceutical Innovation Room 6A

11:00am PDT

#231 CH: Quality in Focus: Diethylene and Ethylene Glycol Challenges Content Hub Sails Pav #234 RT: Roundtable Discussion: Interactive Safety Graphics in the Regulatory Decision-Making Process Ballroom 20 D/ Zone 3 #233 RT: Roundtable Discussion: The State of Real-World Evidence for Regulatory Decision-Making - Views from FDA, EMA, and PMDA Ballroom 20 BC/ Zone 2 #232 RT: Roundtable Discussion: Innovation in Manufacturing Globally Ballroom 20 A/ Zone 1 Luncheon Service Exhibit Hall Community Networking Lunch TBD

11:15am PDT

#235 IT: Deloitte Innovation Theater: Drug Safety Unfiltered - Why Isn’t the Needle Moving? Exhibit Hall Theater #1 #236 IT: UiPath Innovation Theater: AI Powered Automation - Reducing Time to Market for Life Sciences Exhibit Hall Theater #2 #237 IT: Snowflake Innovation Theater: Secure and Efficient Gen-AI to Accelerate Research and Development Exhibit Hall Theater #3 #POS 2: Professional Poster Session 2 Posters Exhibit Hall

11:55am PDT

#238 IT: IQVIA Innovation Theater: An Ecosystem Approach to Site Tech Overload Exhibit Hall Theater #1 #239 IT: Fortrea Innovation Theater: Teamwork Makes the Dream Work - How Partnering to Develop Practical Solutions that Address Site and Patient Challenges is Changing the Clinical Trial Landscape Exhibit Hall Theater #2 #240 IT: UBC Innovation Theater: RWD Enrichment Studies - Linking Pre and Post-Trial Data to Inform Product Strategy Exhibit Hall Theater #3

12:30pm PDT

#241 CH: Practical (and Real) AI and Advanced Automation in New Product Planning and Clinical Development Content Hub Sails Pav

12:35pm PDT

#242 IT: PCM Trials Innovation Theater: Mastering the Logistics of Mobile Visits in Global Decentralized Trials Exhibit Hall Theater #2 #243 IT: ProductLife Group Innovation Theater: Navigating the AI “boom” - A Methodological Framework to Create New Value Streams in your Specific Regulatory Affairs Context Exhibit Hall Theater #3

1:15pm PDT

#244: Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time Room 17AB #252: Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features Room 15AB #247: Bridging Randomized Clinical Trials and Real-World Data Utilizing Data Linkage and Tokenization Room 14AB #248: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle Room 6F #249: Topics Related to the Oncology Real-Time Oncology Review Process Room 1AB #250: Implementable Approaches to Fully Integrating Patient Engagement Across an Entire Company: Including all Clinical Trials Room 2 #246: The State of Clinical Trials in 2024: Are We Making the Grade? Room 11AB #251: Enabling Patient Access Worldwide Including Japan or Other Countries to Innovative Drugs Through Global Development Strategy Room 6D #253: Platform Technology Designation: Opportunities and Challenges for Implementation Room 6B #254: FDA Rare Disease Town Hall Room 6A #245: The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On Room 5AB #255: International Harmonization to Support Pharmaceutical Quality and Lifecycle Management Room 6C #256: Successful Strategies for Leading and Influencing Without Authority in an Evolving Digital Landscape Room 8

2:15pm PDT

#259 RT: Roundtable Discussion: Be Creative and Innovative - A Simple Step-by-Step Decision Science Based Process for You and Your Team Ballroom 20 D/ Zone 3 #257 RT: Roundtable Discussion: Good Data Governance Practices - Regulatory and Industry Perspectives Ballroom 20 A/ Zone 1 #258 RT: Roundtable Discussion: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability Ballroom 20 BC/ Zone 2 Refreshment Break Exhibit Hall

2:30pm PDT

#259.1 IS: Arnold Venture Innovation Session: Better Drug Information for Payers, Physicians, and Patients Content Hub Sails Pav #260 IT: Milliman IntelliScript Innovation Theater: Pre-Screening for Clinical Trials - The Revolution Starts in 3, 2, 1… Exhibit Hall Theater #1 #261 IT: Parexel Innovation Theater: FSP Partnership - A Foundation for Innovation and Patient-Guided Development Exhibit Hall Theater #2 #262 IT: Weave Innovation Theater: Minutes, Not Months - How to Draft an Efficient IND Exhibit Hall Theater #3

3:15pm PDT

#263: Risk Management Planning- Some Twenty Years Later: Where we Started, How Far we have Come and a Modern Path Forward Room 6B #265: Practical Approaches and Resources to Optimize Advocacy Group - Industry Collaborations: An Update on the PALADIN Consortium Room 5AB #266: Exploiting Real-World Data From Social Media in Patient-Focused Drug Development Room 15AB #270: Something Borrowed Something New for Effective Project Management: Adopting Different Thinking Approaches and New Technologies in Life Science Project Management Room 8 #268: Strategies to Make your Clinical Trials More Inclusive for Patients with Disabilities Room 2 #264: Advancing Innovation in Clinical Trial Design and Conduct Room 6A #269: For Whom the Cell Tolls: Ethics in the Era of Precision Medicine Room 1AB #271: How Will the Increasing use of Real-World Evidence for Regulatory Decision-Making Impact QA Strategies and GCP Inspections? Room 16AB #272: This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice Room 6F #273: How to Provide Necessary Medicinal Products to Children? Room 17AB #267: Evolution of Electronic Product Information in LATAM: Challenges and Opportunities to Improve the Value of Healthcare Room 11AB #274: Regulatory Policy Roundtable: Pharmaceutical Quality, Generics, Innovative Medicines Room 6C #275: Securing the Chain: US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation Room 6D #276: The Promise of Disease Progression Modeling to Bring Treatments to Patients Sooner Room 14AB

4:30pm PDT

#277: FDA's Approach in Harmonize Surveillance for Drugs and Biologics Safety and Quality Data Room 11AB #278: Regulatory, Pharmacoepidemiologic, and Pharmacovigilance Considerations Related to the Safety of Drugs Used During Pregnancy Room 6C #284: Collaboration in an Expanding Regulatory Landscape for Pharmacovigilance Room 5AB #280: Innovation, Agility, and Accessibility in Trial Execution: Exploring the Roles, Pathways, and Potential for Integration of Embedded Clinics, Retail Pharmacies, and Diagnostic Providers in Clinical Research... Room 1AB #281: Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU Room 6B #282: Shame and Blame: Our Words are a Barrier to Clinical Research are a Care Option Room 15AB #279: Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials Room 6F #285: Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox Room 16AB #286: Recent Evolution of Accelerated Approval Pathways: Impacts on the Pathways Use and Implementation Room 6A #287: ANVISA Town Hall Room 14AB #288: Middle East Town Hall Room 6D #289: Post-COVID cGMP Inspections by Global Regulatory Authorities Room 17AB #290: Charting the Biosimilars Beat Drop: The Latest Updates in the Biosimilars Landscape, Coverage, and Adoption in the US Room 8 #283: The Value of Project Management in Driving Drug Discovery Success: A Comparison Between Small Versus Large Pharmaceutical Companies Room 2

7:00am PDT

Coffee and Light Refreshments Sails Pavilion

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 #302: Have a Safe Trip: Clinical and Patient Alignment in Clinical Trials with Psychedelics Room 6A #308: Unlocking Innovation: Implementing Future-Focused Risk-Based Quality Management Quality Briefs - A Cross-Functional Challenge Room 8 #309: FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?” Room 6F #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

9:00am PDT

Coffee Break Exhibit Hall

9:15am PDT

#314 IT: IQVIA Innovation Theater: Pre-Approval Access - Strategies for Providing Investigational Product to Patients Beyond Clinical Trials Exhibit Hall Theater #1 #315 IT: ArisGlobal Innovation Theater: Unleashing the Power of Automation and Understanding the Promise of GenAI in Pharmacovigilance and Regulatory Affairs Exhibit Hall Theater #2

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 #320: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases Room 8 #321: The ChatBot Will See You Now: Ethical Considerations in Incorporating AI into Informed Consent Room 7AB #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

11:00am PDT

#329 RT: Roundtable Discussion: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle Ballroom 20 A/ Zone 1 #330 RT: Roundtable Discussion: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases Ballroom 20 D/ Zone 3 #330 RT: Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation Ballroom 20 BC/ Zone 2 Luncheon Service Exhibit Hall

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 #346: A Clinical Research Workforce in Crisis: Imperatives for a Sustainable Staffing Model Room 6C #351: Revolutionizing Quality Management: Harnessing the Power of AI for Enhanced Decision Making and Continuous Improvement Room 17AB #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 #350: ICH Efforts to Incorporate Patient’s Perspective to Enhance Quality, Relevance, Safety and Efficacy of Drug Development Room 11AB #355: Unlocking the Puzzle of Borrowing Adult Data for Designing Innovative Hybrid Pediatric Trials Room 8

2:15pm PDT

#356 RT: Roundtable Discussion: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent Ballroom 20 A/ Zone 1 #357 RT: Roundtable Discussion: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience Ballroom 20 BC/ Zone 2 Refreshment Break Exhibit Hall

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 #360: More than Meets the Eye: AI’s Potential to Identify Skin Manifestations of Internal Disease in Patients of Color Room 6B #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 #361: Recruitment Optimization in Clinical Trials: Looking Towards an Adaptive Future Room 6D #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: Sustainability of Rare Disease Drug Development Room 6F #376: Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best PracticesPerspectives and Best Practices Room 6E #377: Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework Room 1AB #378: From X to Z: Unleashing the Power of Multigenerational Collaboration in Life Sciences – The Basics for All Room 8

7:00am PDT

Coffee and Light Refreeshments Sails Pavilion

8:00am PDT

#401: Harnessing Real-World Data to Generate Real-World Evidence for Regulatory Grade Safety Studies Room 6F #407: Leveraging Statistical Approaches in Drug Safety Analysis Room 1AB #404: Meeting in the Middle: Best Practices for Collaboration Between Medical Affairs and Clinical Development Room 8 #402: Harnessing Generative AI to Translate Questions into Insights Room 6C #403: Achieving Diversity in Clinical Research Using Digital Health Technologies Room 5AB #405: The FDA's Commitment to Patient-Centric Research: Key Themes from Decentralized Trial Draft Guidance Room 6A #406: More Nuanced Clinical Outcomes from Person-Generated Health Data: The New Frontier Room 6B #408: Targeting Hope for Oncology Patients: Perceptions and Considerations for Genetic Testing and Precision Medicine Room 6D #409: Dive into the Power of Diversity: Leveraging Transferable Skills from Regulated Industries to Regulatory Agencies in Medicines Development Room 2

9:15am PDT

#411: Generative AI-Driven Clinical Data Management: A Myth or a Reality? Room 6D #410: The Impact of Racial Discrimination on the Patient Clinical Trial Experience Room 1AB #412: Unleashing Biopharma Potential: Maximizing Consortia Engagement with Strategic Change Management Room 2 #413: What is the Value of Reference Agency Assessment Reports in Enabling Reliance and What do Relying Agencies Require? Room 6C #414: Regulatory Affairs of the Future: Is Now Room 6B #415: EMA-FDA Question Time Room 6A

10:15am PDT

Coffee Break Ballroom 6 Lobby

10:45am PDT

#416: FDA Town Hall Room 6A