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Monday, June 25

7:00am EDT

7:30am EDT

8:30am EDT

10:00am EDT

10:15am EDT

10:30am EDT

11:00am EDT

#105: Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model Room 253AB #107: The Metamorphosis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials Room 257AB #108: From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design Room 258AB #111: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity Room 209 #115: Regenerative Medicine Advanced Therapies: Facilitating Product Development and Approval Room 156ABC #117: Beyond Robotics Process Automation: Next Generation Integrated QMS for R&D Room 205C #122: Contracting for Value: From Outcomes-Based Contracts to Bundled Payment Programs: What’s Working and Why Room 252AB #106: Signal Management: Separating Needles From Haystacks Room 253C #109: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials Room 258C #110: Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research Room 208 #112: Scientific Communication Key Message Development, Management, and Dissemination Room 210C #113: Patient-Focused Medicines Development: Where It has Led Us to Today, What Challenges Remain, and What Do We Still Need to Do to Achieve Success? Room 151AB #114: A Hot Debate: Perspectives on Benefit and Risk From Patients Across Diseases Room 153ABC #116: Culture: The Link Between Team Culture and Productivity - An Interactive Workshop Room 254AB #118: How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making? Room 205AB #119: ‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017 Room 204AB #120: FDA Innovation in Pharmaceutical Quality Assessment and Inspection Room 206AB #121: Use of Historical Information in Clinical Trial Design Room 256 #123: Unmet Medical Need: Diversity of Definitions and Viewpoints – Detangling the Challenge Room 157AB #124: Analyzing Innovations Progress in the Gottlieb Era Room 210AB

12:00pm EDT

12:30pm EDT

12:45pm EDT

1:15pm EDT

1:30pm EDT

1:45pm EDT

2:00pm EDT

2:15pm EDT

3:00pm EDT

#141: eSource: The Road to Real World Evidence – Are We There Yet? Room 257AB #147: Facilitating Nonclinical Data-Sharing and Access Across the Industry Room 151AB #148: Essential Project Leadership in Navigating an Evolving Regulatory Landscape in Asia-Pacific Room 258C #152: FDA Expectations for Demonstration of Interchangeability Room 206AB #139: Novel Approaches to Pharmacovigilance Collaboration Room 253C #140: How Inspection-Ready is Your Organization? Room 253AB #142: Mobile Accelerometry in Clinical Trials: Potential Applications and Meaningful Outcomes Room 258AB #143: Applying Artificial Intelligence, Machine Language, Natural Language Processing, and Predictive Models in Clinical Trials to Deliver Value to Stakeholders Room 209 #144: The Evolving Biosimilars Landscape: A Medical Affairs Perspective Room 210C #145: A New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors Room 153ABC #146: Development of Microbiome-Derived Therapeutics Room 156ABC #149: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative Room 205C #150: TFDA Town Hall Room 208 #151: Using Real World Evidence for Regulatory Support: Time to Embrace the Future Room 205AB #153: New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges Room 204AB #154: Bayesian Application in Small-Sized Clinical Trials Room 256 #155: Real World Evidence for Value and Access Room 252AB #157: Courageous Leadership Room 254AB #156: International Regulatory Convergence Room 210AB

4:30pm EDT

4:45pm EDT

5:30pm EDT


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