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DIA 2025 Global Annual Meeting
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Monday
, June 9
Virtual
1:00pm •
12P: Real-World Evidence: Navigating the Evolving Landscape of Regulation, Data, and Integration
Tuesday
, June 10
Virtual
9:30am •
21A: Risk-Based Quality Management in Action: Hands-On with a Real Study Protocol
1:00pm •
22P: Accelerating Breakthroughs: Project Management Strategies in Drug Development
Wednesday
, June 11
Virtual
9:30am •
31A: Cell and Gene Therapies 101: Specific Regulatory, CMC, Non-Clinical, and Clinical Requirements and Considerations
1:00pm •
32P: Introduction to Artificial intelligence (AI) Ethics, Regulations and Governance for Life Sciences
Thursday
, June 12
Virtual
9:30am •
41A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials
1:00pm •
42P: Regulatory Strategy Development for Complex Devices and Combination Products
Sunday
, June 15
Planet Word
6:00pm •
Inspire Awards
7:00pm •
DIA Annual Meeting Welcoming Reception - Planet Word
TBD
12:30pm •
Registration
Monday
, June 16
143ABC
2:15pm •
#134: Building a Regulatory Landscape to Support CMC Innovation
3:45pm •
#150: Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C
144ABC
2:15pm •
#135: Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights
3:45pm •
#142: Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience
145AB
2:15pm •
#133: Health Canada Town Hall
3:45pm •
#148: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
146BC
11:00am •
#114: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives
3:45pm •
#147: Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation
147AB
11:00am •
#111: Project Orbis: Six Years Later
2:15pm •
#132: FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding?
3:45pm •
#146: FDA Accelerated Approval Program: Putting Withdrawals in Context
150AB
2:15pm •
#131: International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here
3:45pm •
#149: WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation
151A
2:15pm •
#126: Best Practices for Navigating Divergent Regulatory Feedback
3:45pm •
#140: Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders
151B
11:00am •
#110: Moving Toward Pragmatism in Clinical Trials
2:15pm •
#129: Models of Collaborations to Advance Regulatory Science: Lessons Learned
3:45pm •
#144: Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management
152AB
11:00am •
#109: Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
2:15pm •
#130: Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management
3:45pm •
#145: Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
201
11:00am •
#112: Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation
2:15pm •
#136: Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
3:45pm •
#152: AI in Patient Care: Aspirations and Considerations
202A
11:00am •
#107: From Approval to Access: Integrating Patient Insights into Coverage Decisions
2:15pm •
#127: Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion
3:45pm •
#141: How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development
204ABC
11:00am •
#108: Advancing Innovation Through Essential Drug Delivery Outputs
2:15pm •
#128: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
3:45pm •
#143: Ethics in the Era of Precision Medicine and Advancing Technologies
206
3:45pm •
#151: Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication
207A
11:00am •
#104: A Regulator's View on the Future Vision for Pharmacovigilance
2:15pm •
#123: A Masterclass: Patient Recruitment Campaign Management
3:45pm •
#137: Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting
207B
11:00am •
#106: Real-World Evidence: First Choice or Last Resort?
2:15pm •
#125: Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence
3:45pm •
#139: Efficient Data Exchange: Drivers for End-to-End Standards Adoption
209ABC
11:00am •
#105: Advancing Clinical Outcomes through Digital Health Technology Innovation
2:15pm •
#124: Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases
3:45pm •
#138: Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials
Ballroom
8:00am •
#100: Opening Plenary and Keynote Address: From Personal Journeys to Global Solutions – Collaborating for Innovation and Patient Impact
Ballroom Foyer 3rd Floor
7:00am •
Coffee and Light Refreshments
EH
10:00am •
Coffee Break
12:00pm •
#POS 1: Student Poster Session I
Exhibit Hall Lunch
12:00pm •
Luncheon Service
Innovation Theater 1
10:15am •
#101 IT: IQVIA Innovation Theater: Advancing Clinical Trials with Generative and Agentic AI
12:55pm •
#117 IT: AlphaLife Science Innovation Theater: AI in Action - End-to-End Automation and Quality Control in Regulatory Document Authoring with AI and Veeva Integration
1:35pm •
#121 IT: Taimei Technology Innovation Theater: Transforming eClinical Platform - The New Era of Agentic AI in Data and TMF Management
Innovation Theater 2
10:15am •
#103 IT: OM1 Innovation Theater: Real-World Evidence Generation in a Demanding Era
12:15pm •
#115.1 IT: Salesforce Innovation Theater: Personalized Patient Engagement from Recruitment to Enrollment and Beyond with Life Sciences Cloud
1:35pm •
#122 IT: Parexel Innovation Theater: Agility in Action - Reshaping the Clinical Research Workforce
Innovation Theater 3
10:15am •
#102 IT: Lokavant, Inc Innovation Theater: Uncertainty Drives Innovation - Four Use Cases of AI-Powered Study Forecasting
12:55pm •
#118 IT: PCM Trials Innovation Theater: Insights from Across the Care Continuum - How Community-Based Research Supports Trial Success
1:35pm •
#120 IT: Evernorth Health Services Innovation Theater: Empowering Case Managers - Bridging Patient Education and Oncology Clinical Trial Enrollment
L Street Bridge
12:10pm •
#115 CH: Leading Teams Through Organizational Change and Layoffs: Best Practices for Change Management
1:30pm •
#119 CH: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products
Nationals Park
6:45pm •
DIA at the Nationals Park
Salon B
11:00am •
#113: Accelerating Global Access to Drugs for Chronic Diseases
TBD
2:15pm •
#136.1: Ushering in a New Era of Africa Healthcare
Tuesday
, June 17
143ABC
8:30am •
#204: Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence
10:30am •
#228: Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management
1:45pm •
#252: Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency
4:00pm •
#274: Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk
144ABC
8:30am •
#208: International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers
10:30am •
#229: Bayesian Benefit-Risk Analysis: A Framework for Quantitative Evidence-Based Decision Making in Medical Product Development
1:45pm •
#253: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
4:00pm •
#275: Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies
145AB
8:30am •
#209: A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge
10:30am •
#227: ANVISA Town Hall
1:45pm •
#251: China Town Hall
4:00pm •
#272: Towards Instantaneous Regulatory Decisions and Better Predictability
146BC
8:30am •
#211: Redesigning Research and Development with Women in Mind: Turning Ambition to Impact
10:30am •
#226: US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases
1:45pm •
#246: US Executive Orders: Impact on Precision Medicine and Diagnostic Development
4:00pm •
#270: Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance
147AB
8:30am •
#207: Japan Town Hall
10:30am •
#225: Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development
1:45pm •
#249: Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives
4:00pm •
#271: Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products
150AB
10:30am •
#215: The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?
1:45pm •
#242: Not all AI is Equal: Ensuring Reliable, Responsible AI to Accelerate Adoption, Innovation, and Impact
4:00pm •
#268: New Data and Insights on the Vendor Qualification Process in Drug Development
151A
8:30am •
#205: Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem
10:30am •
#219: Resilient Leadership: Overcoming Isolation and Adversity
1:45pm •
#244: How Medical Writing and Regulatory Strategy Can Support Accelerating the Development of Rare Disease Therapies: Insights from the FDA’s START Program Pilot
4:00pm •
#265: Breaking Barriers: Making Health Information Accessible to All
151B
8:30am •
#210: MHRA Town Hall
10:30am •
#223: Transforming the Project Management Role to Meet the Emerging Needs in Pharma: Extending Scope from R&D Focus to Launch Projects
1:45pm •
#247: Guerrilla Strategic Delivery
4:00pm •
#267: Delivering Effective Business Transformations and How to Apply them to Drug Development
152AB
8:30am •
#206: Alphabet Soup: Utilization of Quality-by-Design and Risk-Based Quality Management in Clinical Trials Data Governance - A Multi-Regulator Inspection Perspective
10:30am •
#224: FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct
1:45pm •
#248: Embracing ICH E6(R3) with Risk-Based Quality Management
4:00pm •
#269: Pharmacovigilance Inspections Fireside Chat
201
10:30am •
#221: Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities
4:00pm •
#277: Getting the Work of Medicines Development and Manufacturing Done by Hook or by Crook: Attracting, Retaining and Developing Key Talent in the New World of Work
202A
10:30am •
#220: Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
1:45pm •
#245: Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact
4:00pm •
#262: Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration
204ABC
10:30am •
#222: Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers
1:45pm •
#241: Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision
4:00pm •
#266: Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics
206
8:30am •
#202: From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age
10:30am •
#230: Banishing Burnout: A Practice of Mindfulness Tools to Reduce Stress and Improve Well-Being
1:45pm •
#254: Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development
4:00pm •
#276: Exploring Regulator Career Paths: How Breadth of Experience Informs Decision Making and Medicines Development?
207A
8:30am •
#201: Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates
10:30am •
#216: The Globalization of Risk Management
1:45pm •
#240: Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology
4:00pm •
#261: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
207B
8:30am •
#203: Realizing Value Through Responsible AI in Clinical Development
10:30am •
#218: Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence
1:45pm •
#243: The Adoption of Artificial Intelligence and Machine Learning in Clinical Research
4:00pm •
#264: How Do We Get from Here to There: Putting Real-World Data Quality Assessments into Practice
209ABC
10:30am •
#217: Case Studies of Application of AI in Risk-Based Quality Management
1:45pm •
#250: Pediatric Cluster Town Hall
4:00pm •
#263: Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation
EH
9:30am •
Coffee Break
11:30am •
#POS 2: Professional Poster Session II
11:30am •
Luncheon Service
2:45pm •
Refreshment Break
Exhibit Hall / Zone A
12:00pm •
#234 RT: Roundtable Discussion: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
2:55pm •
#255 RT: Roundtable Discussion: International Regulatory Harmonization for Development of Medicines - A Look at How far We’ve Come and Where We Go From Here
Exhibit Hall / Zone B
12:00pm •
#235 RT: Roundtable Discussion: Building a Regulatory Landscape to Support CMC Innovation
2:55pm •
#256 RT: Roundtable Discussion: Alphabet Soup - Utilization of Quality by Design and Risk Based Quality Management in Clinical Trials Data Goverernance
Exhibit Hall / Zone C
12:00pm •
#235.1 RT: Roundtable Discussion: Clinical Care vs Research - Walking the Ethical Tightrope Between Advocacy and Coercion and Updating Ethics What's New in Declaration of Helsinki
2:55pm •
#256.1 RT: Roundtable Discussion: Participant Compensation in Clinical Trials and Using Generative AI to Explore our Track Record on Paying Participants
Exhibit Hall Lunch
11:00am •
DIA Global Annual Meeting Blood Drive
Innovation Theater 1
9:45am •
#212 IT: IQVIA Innovation Theater: The Future is Now - Transforming Regulatory Processes through AI, ML, NLP, and RPAs
11:45am •
#232: Arnold Ventures Innovation Theater: Biosimilars Today - Who is Winning the Global Race?
12:25pm •
#236.1 IT: Whatfix Innovation Theater: Closing the Digital Execution Gap in Life Science - A Practical Path to Compliance, Efficiency, and Speed
1:05pm •
#239 IT: Syneos Health Innovation Theater: From Pilot to Powerhouse - Scaling AI for Life Sciences
3:00pm •
#260 IT: Weave Bio Innovation Theater: Advancing the Regulatory Lifecycle - Evolution of the Weave Platform
Innovation Theater 2
9:45am •
#213 IT: Clario Innovation Theater: Striking the Balance - Integrating Patient-Friendly Solutions Without Compromising Quality Science
11:45am •
#233 IT: Yseop Innovation Theater: Scaling Regulatory Automation - The One-Click Vision
12:25pm •
#237.1 IT: Salesforce Innovation Theater: Life Sciences Cloud - An Intelligent Clinical Engagement Platform
3:00pm •
#258 IT: Certera Innovation Theater: Generative AI Beyond the CSR - Automating the Submission Dossier
Innovation Theater 3
9:45am •
#214 IT: Aris Global Innovation Theater: Successful Implementation of Gen AI in Pharma - Strategy, ROI, and Cultural Transformation
11:45am •
#233.1 IT: Microsoft Innovation Theater: Innovating Responsibly - AI in Regulated Environments
12:25pm •
#237 IT: Lilly Innovation Theater: Modernizing Clinical Trials through Digital Health Technologies
1:05pm •
#239.1 IT: Faro Health, Inc Innovation Theater: Real World Applications of AI to Clinical Development
3:00pm •
#259 IT: Milliman IntelliScript Innovation Theater: What are you Missing in Recruitment and Enrollment?
L Street Bridge
1:00pm •
#238 CH: Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts
3:00pm •
#257 CH: Innovative Complex Clinical Trial Designs in Rare Disease Drug Development
Nationals Park
6:45pm •
DIA at the Nationals Park
Room 145-147 Lobby
8:00am •
Coffee and Light Refreshments
Salon B
4:00pm •
#273: Regulatory Cooperation Between US and Japan
TBD
11:40am •
#231 CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials
Wednesday
, June 18
143ABC
8:30am •
#311: How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance
10:30am •
#327: Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval
1:45pm •
#349: Potency Measurements for Cellular and Gene Therapy Products
4:00pm •
#368: Perspectives on the Adoption of Advanced Manufacturing Technologies
144ABC
10:30am •
#325: Practical Implementation of MRCTs Based on ICH E17 Guidelines
1:45pm •
#350: Unleash the Potential of Synthetic Data and Digital Twins Using AI to Accelerate Drug Development
4:00pm •
#369: Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20
145AB
8:30am •
#310: Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards
10:30am •
#314: From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14
1:45pm •
#345: Africa's Evolving Regulatory Landscape
4:00pm •
#370: Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development
146BC
8:30am •
#312: Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges
10:30am •
#328: Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health
1:45pm •
#347: EMA Town Hall
4:00pm •
#366: FDA Rare Disease Town Hall
147AB
8:30am •
#308: The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways
10:30am •
#326: Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance
1:45pm •
#346: Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success
4:00pm •
#367: Beyond Weight Loss: Pioneering the Future of Obesity Drug Development
150AB
8:30am •
#309: Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum
10:30am •
#316: Research in Participants with Progressive Cognitive Impairment: Best Practices for Ensuring Continuing Informed Consent
1:45pm •
#348: Indonesia Town Hall
4:00pm •
#365: International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs
151A
10:30am •
#320: Delivering Business Value by Utilizing AI and Structured Content Authoring Tools in Regulatory Medical Writing
1:45pm •
#342: Evolving Regulatory Considerations for Medical Affairs Communications
4:00pm •
#364: Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators
151B
10:30am •
#323: Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development
1:45pm •
#343: Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations
4:00pm •
#357: Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders
152AB
8:30am •
#306: Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives
10:30am •
#324: Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
1:45pm •
#344: Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?
4:00pm •
#363: Critical to Quality Assessment Reports from Inception to Operationalization: How to Engage Internal Stakeholders
201
10:30am •
#318: Patient Referral: Is It Hope or Hype?
1:45pm •
#340: Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe
4:00pm •
#362: Collaborating for Equity: Reaching Communities Through Partnerships with Federally Qualified Health Centers and Community Health Workers
202A
8:30am •
#302: From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care
10:30am •
#321: Why Patient/Site Collaboration is a Must Have to Ensure Accessibility of Digital Health Technologies and Development of Patient Relevant Clinical Endpoints
1:45pm •
#336: Addressing Challenges in Devices Safety Monitoring
4:00pm •
#361: Enhancing the Integration of Patient Experience in Assessing Treatment Tolerability
204ABC
8:30am •
#301: Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
10:30am •
#322: Navigating the Challenges of Drug Delivery Using a Novel Device
1:45pm •
#338: Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan
4:00pm •
#360: Maximizing the Voice of the Patient in Healthcare Decision-Making: Integrating Patient Experience Data into Regulatory, Value Assessment, and Payer Decision-Making
206
10:30am •
#329: Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance
1:45pm •
#351: Transforming Industry through Mentorship
4:00pm •
#371: Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations
207A
8:30am •
#303: Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?
10:30am •
#315: Data and Methods for Signal Detection: Where are we Today and What is the Current State of the Art
1:45pm •
#337: AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
4:00pm •
#356: Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels
207B
8:30am •
#305: Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Automation and Regulatory Review
10:30am •
#319: Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development
1:45pm •
#341: Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research
4:00pm •
#358: Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges
209ABC
8:30am •
#304: Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities
10:30am •
#317: Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa
1:45pm •
#339: Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation
4:00pm •
#359: Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?
EH
9:30am •
Coffee Break
11:30am •
#POS 3: Professional Poster Session III
2:45pm •
Refreshment Break
Exhibit Hall / Zone A
12:00pm •
#331 RT: Roundtable Discussion: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects
2:55pm •
#352 RT: Roundtable Discussion: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products
Exhibit Hall / Zone B
12:00pm •
#332 RT: Roundtable Discussion: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
2:55pm •
#353 RT: Roundtable Discussion: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma
Exhibit Hall / Zone C
12:00pm •
#333 RT: Roundtable Discussion: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
2:55pm •
#354 RT: Roundtable Discussion: Towards Instantaneous Regulatory Decisions and Better Predictability
Exhibit Hall Lunch
11:30am •
Luncheon Service
Innovation Theater 1
9:45am •
#313 IT: IQVIA Innovation Theater: Harnessing the Power of Artificial Intelligence in Medical Affairs - Driving Efficiencies and Preserving Trustworthiness
Innovation Theater 2
9:45am •
#313.1 IT: Synterex, Inc Innovation Theater: AgileWriter.ai™ - Your All-in-One Solution for Authoring and Managing Clinical Trial Documentation
L Street Bridge
11:40am •
#330 CH: Pharmacoequity: The Route to Representative Clinical Trials in the Current Political Environment
12:20pm •
#334 CH: Addressing Key Challenges in Global Biosimilar Development and Regulation
1:00pm •
#335 CH: Can Drug Repurposing Benefit Drug Development In Children and In Paediatric Rare Diseases?
3:00pm •
#355 CH: Business Agility in the Age of AI - Why Zooming in Matters Just as Much as Zooming Out
Room 151A
8:30am •
#307: Regulators and Communication in a Changing World: The ICMRA Role
Thursday
, June 19
144ABC
9:00am •
#406: Beyond the Frequentist Approach in Hard to Recruit Populations: Acceptance of Bayesian Methods for Registration/Pivotal Trial
145AB
9:00am •
#402: Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
146ABC
10:30am •
#408: FDA Town Hall
146BC
9:00am •
#405: EMA - FDA Question Time
151A
9:00am •
#401: Implementing the Aggregate Safety Assessment Planning and Aggregate Safety Review with an Interactive Application: Learnings and Enhancements
151B
9:00am •
#407: Bridging Science and Business: A Roadmap from Pharmaceutical Research to Successful Entrepreneurship
152AB
9:00am •
#404: Embedding and Leveraging AI for Quality and Compliance in Pharma
207B
9:00am •
#403: How AI is Transforming the Area of Data Standards and Access to Source Data
Room 145-147 Lobby
8:00am •
Coffee and Light Refreshments
10:00am •
Coffee Break
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EH
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