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Wednesday, June 27

7:00am EDT

8:00am EDT

#317: Operationalizing Real World Evidence and Value Room 257AB #319: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance: No Longer Going It Alone Community Zone NE Lobby #320: DIA Patient Engagement Community Round Table Discussion: Reaching the Underserved - Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels Community Zone NE Lobby #321: PowerUp: Career Transforming Moments Room 157AB #301: Automation in Pharmacovigilance: Doing More With Less Room 253C #302: Risk Communication and Patient Safety: Recent Learnings and New Approaches Room 253AB #303: Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial Room 258C #304: Data and Quality Approaches to Informing Global Investigative Site Selection Room 258AB #305: Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders Room 254AB #306: phactMI: A Collaborative Approach to Advancing the Practice of Medical Information and Enabling Innovative Customer Solutions Room 210C #307: Maintaining Patient Engagement in the Development of Patient-Reported Outcome (PRO) Measures Room 153ABC #308: How Do Patients and Other Multi-Disciplinary Stakeholders Collaborate to Develop Patient Registries which Accelerate Research? Room 151AB #309: Evolution and Harmonization of First-in-Human Guidelines Room 156ABC #310: Becoming Highly Self-Aware: Leading in the Midst of Ambiguity Room 252AB #311: Harnessing the Power of Data and Analytics to Enhance Quality Room 205C #312: Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH) Room 206AB #313: Global Rare Disease Town Hall Room 205AB #314: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products Room 204AB #315: Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes Room 208 #316: Opportunities for Efficient and Innovative Study Designs Room 256 #318: Value-Based Assessment and Contracting: What Needs to be Done to Make it a Best Practice? Room 210AB

9:00am EDT

9:15am EDT

9:30am EDT

9:45am EDT

10:00am EDT

10:30am EDT

#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

11:30am EDT

12:00pm EDT

12:10pm EDT

12:45pm EDT

1:00pm EDT

1:10pm EDT

1:15pm EDT

1:30pm EDT

2:00pm EDT

#361: A New Way of Authoring and Reviewing Documents for Clinical Development Room 258C #362: Do the Evolution: The Future Role of Clinical Data Management Room 209 #372: AdPromo: Assessing Risk in the Current Regulatory Environment Room 206AB #358: Expedited E2B Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations? Room 253AB #359: IMEDS: A Collaboration Based on the FDA's Sentinel Initiative Room 253C #360: Implementation of eConsent and Other Digital Clinical Trial Innovations Room 258AB #363: Innovative and Effective Authoring Strategies to Facilitate Accelerated Regulatory Submissions Room 157AB #364: Achieving Customer Centricity to Advance Patient Care Through Innovative Communication Channels Room 210C #365: Engaging the Rare Disease Community to Design Clinical Trials Room 151AB #366: Gene Therapy Clinical Trials: Current Challenges Room 156ABC #367: Real Life Strategies for Collaborative Stakeholder Management Room 252AB #368: Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling Room 153ABC #369: Virtual Audits: Do They Achieve the Objective? Room 257AB #370: Clinical Outcome Assessments (COA) Endpoints for Use in Rare and Ultra-Rare Disease Clinical Trials Room 204AB #371: What's New in Health Canada: Updates and New Endeavors Room 205C #373: PMDA Town Hall Room 205AB #374: Modernization and Harmonization of Inspectional Approaches Room 208 #375: Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints Room 256 #376: Courageous Hiring Room 254AB

2:15pm EDT

3:00pm EDT

3:15pm EDT

3:25pm EDT

3:30pm EDT

4:00pm EDT


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