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Tuesday, June 27
 

8:30am CDT

Illuminating Risk Minimization Effectiveness Measurement TBD Ethical Considerations for Conducting Research During Times of Disruption TBD Innovating Patient Recruitment Through Pharmacy Channels TBD ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange TBD The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives  TBD Innovation Across Medical Affairs Throughout the Global Pandemic TBD Leveraging Analytics, Visualizations, and Decision Science to Drive Strategic Decision Making TBD International Regulatory Convergence and Collaboration TBD Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed? TBD Office of Generic Drugs/Office of Pharmaceutical Quality Town Hall TBD

10:30am CDT

Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report TBD Good Recruitment Practice Under Regulation (EU) No 536/2014 TBD The Future of Regulatory Submissions: Opportunities and Challenges TBD Medical Storytelling Inserted Into All Aspects of Medical Affairs TBD Disrupting the Status Quo: Best Practices for Bringing Together Patients and Medical Staff to Positively Impact Trial Diversity TBD The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) Collaboratory: Facilitation of Medical Product Development for Rare Diseases TBD IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Quality Analytics Use Cases and Early Health Authority Feedback TBD ANVISA Townhall TBD International Harmonization of Real-World Data/Real-World Evidence Use and Acceptance by Health Authorities: Time to Make it Right! TBD Patient Experience Data in the Label: Closing the Loop TBD Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment TBD A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines TBD The Full Picture: Innovative Software Tools for Data Insight Generation TBD Is Mark Cuban Really Solving the Drug Pricing Problem? TBD

1:15pm CDT

Novel Methods for Signal Identification for Medicines and Medical Devices TBD Hot off the Press: Site Challenges and Solutions in Workforce and Technology TBD Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape TBD Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives TBD Tech-Enabled Narratives: Technology Meets Process FTW (For the Win!) TBD Measuring Impact of Patient Engagement Across Research and Development TBD Using Artificial Intelligence to Illuminate Predictive Relationships and Discover Biomarkers from Clinical, Molecular, and Digital Data TBD Getting Things Done in Drug Development Using Agile Practices TBD Pharmacovigilance: Regulator's Perspectives on Quality Approaches to Additional Risk-Minimization Measures and Post-Pandemic Inspection Reflections TBD Asia Town Hall TBD Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions TBD One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot! TBD Quality in the Real World: Diagnosing and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data TBD The Inflation Reduction Act Price Setting: What are the Impacts on Biopharmaceutical Innovation from Different Perspectives? TBD Demystifying the Common Legal Agreements, Key Terms, and Pitfalls for Non-Legal Professionals TBD

4:00pm CDT

Negotiating your Way Through the Vigilance Agreement Maze: Is There a Better Way? TBD Smarter Approaches to Pharmacovigilance Challenges TBD Can Pragmatic Trials Simultaneously Meet the Needs of Regulators, Payers and Clinical Care? TBD The Many Faces of In-Trial Interviews: Navigating Operational and Scientific Waters to Optimize Value for Clinical Trials TBD IDMP and Data Harmonization Methods: How Your Company will be Impacted TBD SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data TBD Generating Patient Insights to Inform Health Policy Issues: Policy Patient Engagement Research Councils (PERCs) TBD An Assessment of the Challenges Associated with Cell and Gene Therapies: Are Digital Health Technologies the Way Forward? TBD Data Analytics for Quality Assurance: Shifting the Paradigm from Issue Detection to Quality Evidence Generation TBD Globally Accelerating the Drive to eLabeling for All TBD PMDA Town Hall TBD Quality Aspects of FY23-28 User Fee Agreements TBD Patient-Preferences and Multistate Models to Enhance Patient-Focus of Traditional Endpoints in Oncology TBD Improving Patient Access with Real-World Evidence: A Framework for Coverage and Formulary Decisions 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