Agenda

Day 1 Jun 15, 2020

11:00 AM — 12:00 PM

Clinical Trials in a Digital Age: A Modern Approach to an Outdated Model

1:30 PM — 2:30 PM

How Do You Oversee and Manage New Centralized/Remote/Site Monitoring Models? What Should you Measure to Gain Insights?

3:30 PM — 4:30 PM

The Rare Disease Clinical Outcome Assessment Consortium: Aiming to Fulfill Unmet Drug Development Endpoint Measurement Needs

Day 2 Jun 16, 2020

8:00 AM — 9:00 AM

Novel Approaches to Study Prevalent Chronic Diseases as Alternatives to Large-Scale Clinical Trials

9:30 AM — 10:30 AM

Data Driven Monitoring Enabled Through Analytics and Quality Risk Management

11:30 AM — 12:30 PM

Non-Traditional Clinical Trials Require a Non-Traditional Workforce

2:00 PM — 3:00 PM

Examining Diversity in Clinical Trials

2:00 PM — 3:00 PM

Practical Solutions for Designing and Conducting a Digital Health Trial

Day 3 Jun 17, 2020

8:00 AM — 9:15 AM

Balancing Science, Regulation, and Social Good in Clinical Trial Participant Diversity

9:30 AM — 10:30 AM

If You Build it, Will They Come? What’s Really Needed to Transform Information Flow in Clinical Development

11:30 AM — 12:30 PM

Evolving Trials for the Digital Age

4:00 PM — 5:00 PM

The Development of Novel Digital Endpoints

Day 4 Jun 18, 2020

8:00 AM — 9:00 AM

FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies

9:30 AM — 10:30 AM

Qualification and Oversight in Decentralized Trials: Practical Considerations for Clinical Operations and Quality Oversight

11:30 AM — 12:30 PM

How the FDA’s MyStudies Platform is Accelerating the Use of Digital Technology in Clinical Research and Clinical Trials

5:00 PM — 6:00 PM

ON DEMAND - Artificial Intelligence: Use Cases from Real Trials

5:00 PM — 6:00 PM

ON DEMAND - Design and Implementation of Multiregional Clinical Trials (MRCT) Using ICH E17 Guidelines

5:00 PM — 6:00 PM

ON DEMAND - Faster, Better, Cheaper: The Changing Role of Real World Data in Drug Development

5:00 PM — 6:00 PM

ON DEMAND - Journey of TMF Reference Model in Driving Inspection Readiness: The Decade's Impact, the Evolution to Come

5:00 PM — 6:00 PM

ON DEMAND - Managing Global Clinical Trials in Emerging Regions: Latin America

5:00 PM — 6:00 PM

ON DEMAND - Older People Can’t Use ePRO and Other Industry Myths: An Interactive Debate

5:00 PM — 6:00 PM

ON DEMAND - Optimizing Study Start Up Processes: Site Selection, Budgeting, and Contracting

5:00 PM — 6:00 PM

ON DEMAND - Pediatric Clinical Trial Design and Ethical Considerations: Understanding Prospect of Direct Benefit and Risk

5:00 PM — 6:00 PM

ON DEMAND - Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID)

5:00 PM — 6:00 PM

ON DEMAND - Templates That Do More: How We Are Accelerating Drug Development via Structured Content Reuse

5:00 PM — 6:00 PM

ON DEMAND - The Power of Real World Data and the Innovative Approaches for Usage

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DIA 2020 Global Annual Meeting

Agenda

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