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Wednesday, June 18
 

8:30am EDT

10:30am EDT

From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14 TBD Trustworthy AI Solutions for Next-Generation Pharmacovigilance TBD Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa TBD Patient Referral: Is It Hope or Hype? TBD Research in Participants with Progressive Cognitive Impairment: Best practices for ensuring continuing informed consent TBD Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development TBD Leveraging AI and Structured Content Authoring Tools in Regulatory Medical Writing: A 1-Year Look TBD Why Patient Involvement is a Must Have to Ensure Accessibility to Digital Health Technologies and Development of Patient Relevant Clinical Endpoints TBD Navigating the Challenges of Drug Delivery Using a Novel Device TBD Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development TBD Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality TBD Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance TBD Practical Implementation of MRCTs Based on ICH E17 Guidelines TBD Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval TBD Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health TBD Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance TBD

1:45pm EDT

2:45pm EDT

4:00pm EDT

Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels TBD Examining Bias in Lung Cancer Study Protocols: Lessons Learned TBD Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now? TBD Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges TBD Collaborating for Equity: The FDA OMHHE REACH Consortium's Partnership with Federally Qualified Health Centers and Community Health Workers TBD Successful Patient Input to Regulatory and Health Technology Assessment Processes Along the Development Path: Examples of How to Optimize Impact TBD Quality Briefs from Inception to Operationalization: How to Engage Internal Stakeholders TBD Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators TBD Beyond Weight Loss: Pioneering the Future of Obesity Drug Development TBD FDA Rare Disease Town Hall TBD International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs TBD Regulatory Perspectives on the Adoption of Advanced Manufacturing Technologies TBD Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20 TBD Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development TBD Business Agility: Applying Strategic and Critical Thinking to Recognize Global Business Environment and Adopt Strategies TBD
 
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