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#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
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#333: Streamlining Vendor Reconciliation Room 209
#337: Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally Room 156ABC
#329: Reducing the Burden of Drug Safety Risk Minimization Programs on the Healthcare System: How Do We Do So and What Has Been Learned to Date? Room 253AB
#330: Artificial Intelligence: Robots Taking Over Clinical Research Room 253C
#331: Rebuilding or Building a Research Site in the Year 2020 Room 254AB
#332: Clinical Data: Let’s Get to the Source and Streamline it to the End Room 208
#335: Collaboration Across the Medical Affairs Ecosystem to Advance Patient Care Room 257AB
#336: Addressing the Elephant in the Room: A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement Room 153ABC
#338: You've Got Data #now what? Room 157AB
#339: Determining Data Integrity: Decoding the Impact of Inspectional Observations Room 258AB
#340: Harmonization Beyond ICH Room 206AB
#341: New FDA Draft Guidance on Part 11 in Clinical Investigations Room 204AB
#342: Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How Room 205C
#343: Innovative Visualization Approaches Room 256
#344: Biosimilar Interchangeability: A Global Perspective Room 205AB
#334: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program Room 210C
#345: Unmet Medical Need: Path Forward – Creating a Commonly Agreed Criteria Globally Room 252AB
#346: Precision Medicine, Gene Editing, and Gene Therapy: Current Status and Regulatory Challenges of Integrating Genetic Medicine into Clinical Care Room 210AB
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