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Day 1 2019年6月24日 (月)

11:00 AM — 12:00 PM

Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs

11:00 AM — 12:00 PM

International Regulatory Convergence

2:15 PM — 3:15 PM

Communications with Regulators Beyond Formal Meetings

2:15 PM — 3:15 PM

Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know?

2:15 PM — 3:15 PM

Hype Versus Reality: Artificial Intelligence and Drug Development

2:15 PM — 3:15 PM

TFDA Town Hall: Focus on Regenerative Medicine

2:15 PM — 3:15 PM

Update from Health Canada: The Health Protection Branch

3:30 PM — 4:30 PM

Drug Development Tools in a Digital Era

3:30 PM — 4:30 PM

Strategic Priorities of the International Coalition of Medicines Regulatory Authorities in an Increasingly Globalized Industry

3:30 PM — 4:30 PM

Updates on China Regulatory Reform

Day 2 2019年6月25日 (火)

8:00 AM — 9:15 AM

Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges

8:00 AM — 9:15 AM

Facilitating Access: Patient Perspectives on a Streamlined Development Approach for Treatments for Severely-Debilitating or Life-Threatening Diseases

8:00 AM — 9:15 AM

Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504?

8:00 AM — 9:15 AM

Identifying the Reference Listed Drug for ANDA Submission, Overview of FDA’s Orange Book, and Exclusivities for NDAs and ANDAs

10:30 AM — 11:30 AM

Harmonizing Regulatory Science Through the International Council for Harmonization (ICH)

10:30 AM — 11:30 AM

PMDA Town Hall

10:30 AM — 11:30 AM

The Future of Combination Products in the EU

10:30 AM — 11:30 AM

Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project

2:00 PM — 3:15 PM

Current Status of FDA Framework for the Evaluation of Real World Evidence

2:00 PM — 3:15 PM

Driving Complex Generics to Approval: What are the Keys to Success

4:15 PM — 5:30 PM

Informing Development and Authorizations Using Real World Evidence/Artificial Intelligence

4:15 PM — 5:30 PM

Prescription Drug Labeling: New Guidances from the US FDA

4:15 PM — 5:30 PM

Update From the US FDA on Progress and Topics of Current Interest in US Biosimilar Policy, Regulation, and Outreach/Education

Day 3 2019年6月26日 (水)

8:00 AM — 9:15 AM

Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now?

8:00 AM — 9:15 AM

Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why

10:30 AM — 11:30 AM

Digital Technology Advances Labeling Management and Patient Access

10:30 AM — 11:30 AM

Hot Topics in Quality and Regulatory Affairs for Combination Products

10:30 AM — 11:30 AM

The Evolving Gene Therapy Regulatory Framework: A Brave New World

10:30 AM — 11:30 AM

When is Real World Evidence Ready for Prime Time?

2:00 PM — 3:15 PM

Global Rare Disease Town Hall

2:00 PM — 3:15 PM

Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned?

2:00 PM — 3:15 PM

User-Fee Programs Myth Busting: General Financial Principles Explained

4:15 PM — 5:30 PM

Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Experience, Analysis, and Reflections from EMA, FDA, and Industry

4:15 PM — 5:30 PM

Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints

4:15 PM — 5:30 PM

Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products

4:15 PM — 5:30 PM

Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies

4:15 PM — 5:30 PM

Transparency, Expanded Access Navigator, Right to Try: Helping Patients Get Access to Investigational Medicines?

Day 4 2019年6月27日 (木)

9:00 AM — 10:15 AM

Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics

DIA 2019 Global Annual Meeting

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