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Wednesday, June 28
 

8:30am CDT

Advancing PV in Africa TBD Using Real-World Data to Evaluate Safety Signals TBD Returning Individual Participant Data: A Cultural and Operational Shift Towards Personalized Clinical Trial Options TBD Real-World Data Quality: Components and Considerations of Data Sources Used for Regulatory Decision-Making TBD The Rapidly Changing Landscape of Data Collection and its Implications for Clinical Data Management TBD Writing Summary Documents for Rare Disease Submissions: Unique Challenges TBD Leveraging Project Management Skills for Significant Drug Development Deliverables TBD Strategies for Benefit-Risk Analysis in Regulatory Submissions TBD Strategies to Make the Right Virtual Connection: Play and Learn TBD

10:30am CDT

Opportunities to Improve Risk Minimization Outcomes with Behavioral Science TBD Registries Aren’t Always the Answer: Novel Designs for Executing Post-Market Pregnancy Requirements TBD Best Practices for Managing Rare Disease Trials in Latin America as an Emerging Trial TBD Leveraging Data Scientists and Data Managers with Evolving Protocol Designs   TBD Operationalizing Real-World Data: Methods, Acceptance, and Future Hopes  TBD Is the Hype Real? Real-Life User Experience of Medical Writing Artifcial Intelligence Tools for Clinical Study Reports Production TBD Combining Qualitative and Quantitative Research to Generate Within-Patient Meaningful Changes in Clinical Outcome Assessments TBD What Can ICH Bring to the Future of Model-Informed Drug Development (MIDD)? TBD PI 1572 Responsibility and Oversight in Decentralized Clinical Trials TBD 25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness? TBD Dose Optimization in Oncology: How Do we Tackle the Tricky Topic of Combinations? TBD Health Canada Town Hall TBD Reliance in Action: How to Ensure Product Sameness When Using Global Supply Chains TBD Patient-Focused Drug Development in Rare Disease Endpoint Selections TBD How Real-World Data from Wearable Biosensors and Artifical Intelligence (A)I-Based Analytics Is Enabling the Shift from Efficacy to Effectiveness TBD

1:15pm CDT

Operationalizing FDA Medical Queries TBD Regulatory Insights into Decentralized Clinical Trials TBD Today’s Episode of Clinical Research Talk Explores Clinical Adjudication and Practical Applications of Artifical Intelligence and Natural Language Processing TBD Managing BYOD and Wearables in Clinical Trials: Sustainable Data Collection TBD Estimands and Designing of the Clinical Trial and Protocol Structure TBD Capturing the Patient Voice Using Longitudinal Qualitative Research Methods in Medical Product Development TBD Fostering Cross-Functional Team Success with Project Management and Alliance Management Best Practices TBD Industry and Regulators’ Experience with the Implementation and Use of Remote Consent TBD FDA Rare Disease Town Hall TBD The Future of Biosimilar and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act TBD Evolving Global Landscape for Addressing Drug Shortages: Innovative Strategies in the Area of Regulatory and Technology TBD Opportunities and Issues with Existing Analytical Technologies for Safety Monitoring of Ongoing Clinical Studies TBD Real-World Data: Maximizing Value and Quality Through End-to-End Patient Centricity TBD Performance, Interrupted: Examining Diversity, Equity, and Inclusion Dynamics that can Impact Team Performance in Drug Development TBD

4:00pm CDT

Assessing Safety in Rare Disease Gene Therapy TBD Modernizing the Clinical Trials Environment in Europe: ACT EU and the New EU Clinical Trial Regulation TBD Patient-Generated Health Data and Real-World Evidence: How Can They Be Used to Accelerate Patient Engagement and Diversity? TBD Leading Cross-Functional Teams Through Mergers, Divestments, and Acquisitions TBD Quality by Design for Real-World Evidence Studies TBD Mobilizing Cooperation with the African Medicines Agency TBD Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Uptake Globally TBD Patient and Quality Impacts of Restrictions on the Use of Titanium Dioxide (TiO2) in Medicines TBD From 1000's of Tables to Summarizing Clinical Trials Graphically TBD Critically Thinking Organization: An Action-Oriented Workshop for Leaders TBD
 
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  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
    • Exh Hall Community Area
    Exhibit Hall
    Exhibit Hall Booth #1719
    Exhibit Hall Theater #1
    Exhibit Hall Theater #2
    Exhibit Hall Theater #3
    Level 3 F2 Entrance
    Meeting Rm Lobby Level 1
    Meeting Room Lobby
    Room 175
    Room 176
    Room 178
    Room 179
    Room 180
    Room 183 A
    Room 183 B
    Room 183 C
    Room 184
    Room 185 AB
    Room 185 CD
    Room 186
    Room 187
    Room 375 A Zone 1
    Room 375 A Zone 2
    Room 470 A
    Room 470 B
    Room 471 A
    Room Skyline 375 CDE
    Skyline Ballroom Foyer
    TBD
    Virtual