会议日程
12:00 AM — 12:00 AM
12:00 AM — 12:00 AM
12:00 AM — 12:00 AM
12:00 PM — 1:00 PM
Artificial Intelligence Validation Framework: Is it New and Different?12:00 PM — 1:00 PM
Artificial Intelligence: Real Applications and Regulatory Perspectives12:00 PM — 1:00 PM
Automation in Scientific Writing Deliverables12:00 PM — 1:00 PM
Challenges for Medical Information Sharing12:00 PM — 1:00 PM
NMPA Town Hall12:00 PM — 1:00 PM
Patient-Led Special Initiatives12:00 PM — 1:00 PM
Safety Compliance12:00 PM — 1:00 PM
Continuing the Conversation: What’s New in Gene Therapy and Gene Editing12:00 PM — 1:00 PM
FDA Oncology Center of Excellence Pilot Programs: Past, Present, and Future12:00 PM — 1:00 PM
Gene Therapy Research in Pediatric Populations: Ethical Issues12:00 PM — 1:00 PM
Gene Therapy: Getting Back on Track After COVID-1912:00 PM — 1:00 PM
Impact of COVID-19 on Clinical Trial Execution12:00 PM — 1:00 PM
Modernizing CMC Dossier Format and Review12:00 PM — 1:00 PM
Trial Designs to Minimize Bias and Non-Specific Effects12:00 PM — 1:00 PM
Turbo Charged Professional Development: We're Not in Kansas Anymore!12:00 PM — 1:00 PM
Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA12:00 PM — 1:00 PM
Improving the Ways We Communicate with Patients and Research Participants12:00 PM — 1:00 PM
PMDA Town Hall12:00 PM — 1:00 PM
Workforce Transformation: The Care and Feeding of a Remote Team12:00 PM — 1:00 PM
Asian Town Hall12:00 PM — 1:00 PM
Basics of Healthcare Reform for Lifesciences Professionals12:00 PM — 1:00 PM
Considerations for Innovative Trial Design in CNS9:30 AM — 12:30 PM
#011A: Core Labeling1:00 PM — 4:00 PM
#014P: Data Visualization in the Lifesciences9:30 AM — 12:30 PM
#031A: Developing, Implementing, and Operating REMS Programs9:30 AM — 12:30 PM
#032A: Leadership: How to Organize and Lead People in a Work Group11:00 AM — 12:00 PM
Student and Young Professional Forum1:00 PM — 2:00 PM
Resume Workshop3:00 PM — 4:00 PM
Interviews: The Obvious and Not-So-Obvious Tips4:00 PM — 5:15 PM
Networking: Understand Yourself and Others for Career Success10:00 AM — 11:45 AM
DIA Global Annual Meeting - Opening DIAmond and Plenary Session12:00 PM — 12:30 PM
How to Share Individual Patient-Level Data Safely for Pharma Innovation12:00 PM — 1:00 PM
Meet the DIA Fellows1:00 PM — 2:00 PM
Defining Quality for Cell and Gene Therapy Products1:00 PM — 2:00 PM
Patient-Centric Engagement Strategies1:00 PM — 2:00 PM
Skills of the Future/The Future of Work1:00 PM — 2:00 PM
Statistical Considerations with the Patient in Mind1:00 PM — 2:00 PM
Technology Changes Needed to Manage Drug Supply for Decentralized Trials2:30 PM — 3:30 PM
Health Canada Town Hall2:30 PM — 3:30 PM
Hiding in Plain Sight: Quantifying Underdiagnosed Populations2:30 PM — 3:30 PM
Risk-Based Remote Site Monitoring2:30 PM — 3:30 PM
Risky Business: How to Successfully Manage Project Risk4:00 PM — 5:00 PM
Challenges and Opportunities in Early Development of RNA Therapeutics4:00 PM — 5:00 PM
Culture of Quality: A Competitive Advantage4:00 PM — 5:00 PM
Driving Innovation in Data Standards and Regulatory Submissions at FDA4:00 PM — 5:00 PM
How Can We Compliantly Exchange Pre-Approval Information with Payers4:00 PM — 5:00 PM
Implementation Progress of ICH Q124:00 PM — 5:00 PM
Realizing the Value of Digital Biomarkers Across the Product Lifecycle8:00 AM — 8:45 AM
Unqork Innovation Theater: Unqork for Clinical Trials9:00 AM — 10:00 AM
Spotlight Symposia: Three Paths to Success in a Post-COVID World10:00 AM — 11:00 AM
Advancing Medicines’ Regulation in Europe: Key Strategies to 202510:00 AM — 11:00 AM
Brave New World: Early Clinical Trials in a Pandemic10:00 AM — 11:00 AM
Global Harmonization of Complex and Innovative Trial Designs10:00 AM — 11:00 AM
Managing Global Trials in Latin America: Covid Impact Update10:00 AM — 11:00 AM
Office of Generic Drugs and Office of Pharmaceutical Quality Generics Town Hall10:00 AM — 11:00 AM
Pediatric Engagement in Research: Young People Have a Voice10:00 AM — 11:00 AM
Post COVID: Sites Evolving Role in the Clinical Trial Ecosystem11:00 AM — 11:30 AM
Patient-Reported Outcomes: Going Beyond Clinical Trials11:00 AM — 11:30 AM
PPD Innovation Theater: Capacity Management Through Upheaval12:00 PM — 1:00 PM
How to Ensure Quality in Cell and Gene Therapies1:30 PM — 2:00 PM
Solution Circle: Conducting Clinical Trials in China1:30 PM — 2:00 PM
The Clinical Impact of Medical Information for Healthcare Professionals2:00 PM — 3:00 PM
Are External Control Arms Ready for Primetime?2:00 PM — 3:00 PM
GCP Quality and Compliance: The Regulator’s Perspective2:00 PM — 3:00 PM
Navigating Non-Trial Preapproval Access as a Patient2:00 PM — 3:00 PM
Systems Thinking: A Better Way of Safety Management Planning3:00 PM — 4:00 PM
Patient Scholar Meet Up4:00 PM — 5:00 PM
Frameworks for Digital Endpoints via the IND Pathway4:00 PM — 5:00 PM
Innovative Approaches to Trial Execution, Quality, and Compliance4:00 PM — 5:00 PM
Parents Just Don’t Understand: Does This Apply to Healthcare Too?9:30 AM — 10:00 AM
Including Data Science in DIA10:00 AM — 11:00 AM
Best Practices for Project Managers Working in Drug Development Collaborations10:00 AM — 11:00 AM
Clinically Meaningful: How is it Different from Statistical Significance?10:00 AM — 11:00 AM
Worldwide COVID-19 Pandemic Effects on Real-World Data: Research Can Go On11:00 AM — 11:30 AM
Serving Two Masters: Research Glossaries for Industry and Patients11:30 AM — 12:30 PM
When Can You Trust Real-World Evidence for Decision-Making?12:30 PM — 1:30 PM
How Can DIA Help You Advance Your Career? Involvement With DIA1:30 PM — 2:00 PM
Six Secrets for Successfully Leading Remote Teams2:00 PM — 3:00 PM
Best Practices in Governance Meetings2:00 PM — 3:00 PM
Interpreting and Writing About Clinical Trial Data2:00 PM — 3:00 PM
Mixing Modes of Clinical Outcome Assessments in Response to COVID-192:00 PM — 3:00 PM
Risk Minimization Program Evaluation: How Can we Advance the Science?2:00 PM — 3:00 PM
Scientific Advances in Biosimilar Development3:00 PM — 4:00 PM
How Can You Get Involved With the Global Annual Meeting?4:00 PM — 5:00 PM
COVID-19 Vaccines: Regulatory Strategies for Public Health Emergencies4:00 PM — 5:00 PM
Improving Efficiency and Quality of Regulatory Documents4:00 PM — 5:00 PM
Risk-Based Quality Management and Monitoring: Practical Approaches4:00 PM — 5:00 PM
The Intersection of Health Equity and Personalized Medicine4:00 PM — 5:00 PM
Who Should Pay for Expanded Access?9:30 AM — 10:00 AM
Speed to Submission: How Fast Can You Truly Go?10:00 AM — 11:00 AM
Development of Shared System and Shared REMS: Best Practices and Lessons Learned10:00 AM — 11:00 AM
Recent Developments and Strategies in Pediatric Drug Development Documentation10:00 AM — 11:00 AM
Remaining Challenges to the COVID-19 Response10:00 AM — 11:00 AM
Using Cloud-Based Platforms to Transform Global Regulatory Data Exchange10:00 AM — 11:00 AM
Virtual Project Management: A Way Forward!11:00 AM — 11:30 AM
WCG Innovation Theater: Managing Adjudication in an Increasingly Remote World11:30 AM — 12:30 PM
EHR Interoperability Supporting COVID-19 Critical Care and Research11:30 AM — 12:30 PM
Managing the Remote World: Concrete Strategies for Productivity and Balance11:30 AM — 12:30 PM
Mobilizing Manufacturing: Portable and Point of Care Manufacture of Medicines11:30 AM — 12:30 PM
Real-World Evidence: A Global Regulatory Perspective and Discussion11:30 AM — 12:30 PM
Regulator Perspective: Maintaining GCP During Covid-19 and Beyond the Pandemic11:30 AM — 12:30 PM
The Journey to a Modernization of Analytics11:30 AM — 12:30 PM
The Spirit of the IND Safety Reporting Final Rule12:30 PM — 1:30 PM
Advancing Diversity, Equity, and Inclusion in Drug Development12:30 PM — 1:30 PM
Make Connections and Advance Science in DIA Communities1:30 PM — 2:00 PM
Value-Based Contracting in Action2:00 PM — 3:00 PM
EMA-FDA Question Time2:00 PM — 3:00 PM
Mindfulness: The Power to Be Here, Now2:00 PM — 3:00 PM
Population Diversity Considerations in Clinical Trials2:00 PM — 3:00 PM
The Relationship Between Data, AI, and Bias3:30 PM — 4:30 PM
FDA Town Hall