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Monday, June 24

7:00am PDT

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#105: Addressing Heterogeneity of Real World Evidence in Drug Safety Room 6D #106: Moving Forward in EU Pharmacovigilance Room 6C #107: Emerging Technologies in Clinical Research Room 11A #108: Innovation in Enrollment, Recruitment, and Retention Room 9 #109: When Disaster Strikes: Developing a Proactive Plan to Address Challenges Brought on by Large Scale Natural Disasters Room 10 #110: Automation with Intelligence: Transformation From Human Resource to Artificial Intelligence in Risk Management Room 1AB #111: PhactMI Benchmarking Survey Highlights: How are the Twenty Seven Member Companies Executing on Medical Information Initiatives Room 4 #112: Collecting Better Patient Experience Data: Lessons Learned from Patient Organizations Room 5AB #113: Artificial Intelligence in Drug Discovery and Development: Emerging Technologies and Applications Room 2 #114: Patient Perspective Diversity: Taking Cultural Differences in Patient Views Into Consideration in US, EU, and Japan Room 15AB #115: Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2) Room 17AB #116: Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs Room 6F #117: International Regulatory Convergence Room 6B #118: Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval Room 3 #119: Making Value-Based Contracting Stick Room 11B #120: FDA Payer Communication Guidance, Twenty Years in the Making: Now What? Room 14B #121: Emerging Professionals: Making the Most of Your Networking Experience at the DIA Global Annual Meeting Room 14A

12:00pm PDT

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#135: Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity Room 6D #136: Interpretation of New Pharmacovigilance Regulations: Key Insights Room 6C #137: Emerging Technology to Improve Sponsor-Site Interactions Room 11A #138: Blockchain in Clinical Trials Demo: Truth or Dare Room 9 #139: Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans Room 10 #140: Use of Real World Data in Clinical Trials: Abstracting Endpoints from Encounters Room 1AB #141: Knowledge Management and Information Sharing to Support Business Continuity Room 4 #142: Show Me the Money! Patient and Caregiver Roles and Compensation in Research, Development, and Innovation Room 5AB #143: Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology Room 2 #144: Ready or Not: Business Continuity Planning Room 15AB #145: Examining Essential Elements of Vendor Governance and Comparing Perspectives of Large and Emerging Biopharma Room 17AB #146: Communications with Regulators Beyond Formal Meetings Room 6B #147: Update from Health Canada: The Health Protection Branch Room 6F #148: Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know? Room 6E #149: Hype Versus Reality: Artificial Intelligence and Drug Development Room 11B #150: TFDA Town Hall: Focus on Regenerative Medicine Room 14B #151: Update on ICH Quality Topics Room 8 #152: Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis Room 3 #153: How Storytelling, Images, and Engagement Can Wow Your Audience: Presentations with Punch! Room 14A

3:30pm PDT

#154: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI Room 6C #155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research Room 6D #156: Clinical Research in Emerging Regions Room 9 #157: A Large Academic Medical Center’s Perspective on Using Precision Medicine to Find Patient Disease Subgroups at Scale Room 11A #158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development Room 10 #159: Understanding the Data Journey In Virtual Trials Room 1AB #160: New Communication Channels for Medical Information Room 4 #161: Making Trials Work for Special Populations Room 5AB #162: Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption Room 2 #163: Strategic Integration: Is Anyone Getting it Right? Room 15AB #164: Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health Room 17AB #165: Drug Development Tools in a Digital Era Room 6F #166: Updates on China Regulatory Reform Room 6E #167: Strategic Priorities of the International Coalition of Medicines Regulatory Authorities in an Increasingly Globalized Industry Room 6B #168: Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities Room 8 #169: How Statistics Can Help Improve Data Quality: ICH E6 R2 Room 3 #170: Making Early Access for Patients Happen Room 14B #171: The Courage of Career Transitions Room 14A #172 CH: Paving the Path for Family-Centered Design: Caregiver Roles in Medical Product Development Content Hub Sails Pav Community Meet Up: Forum of Pharmacovigilance Quality Heads Community Area Sails Pav

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