DIA 2024 Global Annual Meeting

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DIA 2024 Global Annual Meeting

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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 #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

#241.1 IT: Flatiron Health Innovation Theater Exhibit Hall Theater #1 #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, Pharmacies, and Diagnostic Providers in Clinical Research at Sc... 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 #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