Agenda

天 1 2021 年 06 月 17 日

12:00 PM — 1:00 PM

Electronic Labeling: Where are we Now and What are the Next Steps in the World?

12:00 PM — 1:00 PM

Global Trends in Regulatory Reliance: Will the COVID-19 Experience Accelerate Implementation?

12:00 PM — 1:00 PM

If You Have Questions, Contact the Regulatory Project Manager: Best Practices When Interacting with US FDA Regulatory Project Managers

12:00 PM — 1:00 PM

NMPA Town Hall

天 2 2021 年 06 月 18 日

12:00 PM — 1:00 PM

FDA Oncology Center of Excellence Pilot Programs: Past, Present, and Future

12:00 PM — 1:00 PM

Gene Therapy: Getting Back on Track After COVID-19

12:00 PM — 1:00 PM

How to Engage with EMA Early in Development? Navigating the European Ecosystem to Bring Innovation to Patients

天 3 2021 年 06 月 19 日

12:00 PM — 1:00 PM

Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA

12:00 PM — 1:00 PM

PMDA Town Hall

天 4 2021 年 06 月 20 日

12:00 PM — 1:00 PM

Asian Town Hall

天 5 2021 年 06 月 28 日

1:00 PM — 2:00 PM

FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies

2:30 PM — 3:30 PM

Health Canada Town Hall

2:30 PM — 3:30 PM

Parallel Scientific Advice: Increasing International Dialogue Early in the Product Lifecycle

4:00 PM — 5:00 PM

Continuity of Randomized Controlled Trials During the Trying Times of COVID-19 and What We’ve Learned

4:00 PM — 5:00 PM

Next Generation of Combination Products: Insights from the FDA Office of Combination Products and Industry Expert Application

天 6 2021 年 06 月 29 日

10:00 AM — 11:00 AM

Advancing Medicines’ Regulation in Europe: Key Strategies to 2025

10:00 AM — 11:00 AM

Office of Generic Drugs and Office of Pharmaceutical Quality Generics Town Hall

2:00 PM — 3:00 PM

Global Regulatory Harmonization for Increased Patient Access to Medicines Through the International Council for Harmonisation (ICH)

2:00 PM — 3:15 PM

Update on FDA's Real-World Evidence Program: Current FDA Demonstration Projects

4:00 PM — 5:00 PM

Frameworks for Digital Endpoints via the IND Pathway

4:00 PM — 5:00 PM

Pandemic Preparedness: Accelerating Treatments to Overcome Antimicrobial Resistance

天 7 2021 年 06 月 30 日

10:00 AM — 11:00 AM

Model Informed Drug Development (MIDD) Pilot Program: Experience and Impact Over First Three Years

10:00 AM — 11:00 AM

The FDA's Clinical Trial Diversity Initiative in the Setting of the Ongoing COVID-19 Pandemic

2:00 PM — 3:00 PM

How Has FDARA Section 504 (RACE Act) Changed the Pediatric Oncology Landscape?

2:00 PM — 3:00 PM

Scientific Advances in Biosimilar Development

4:00 PM — 5:00 PM

Companion Diagnostics: Could Co-Development be Expedited to Facilitate Access to Accelerated Novel Therapeutics?

4:00 PM — 5:00 PM

COVID-19 Vaccines: Regulatory Strategies for Public Health Emergencies

天 8 2021 年 07 月 01 日

10:00 AM — 11:00 AM

Integrated Assessment of US Marketing Applications: A View into FDA Internal Operations

10:00 AM — 11:00 AM

Using Cloud-Based Platforms to Transform Global Regulatory Data Exchange

11:30 AM — 12:30 PM

Emergency Use Pathways: What Leanings from COVID-19 Can be Generalized to Address Unmet Medical Needs?

11:30 AM — 12:30 PM

Real-World Evidence: A Global Regulatory Perspective and Discussion

2:00 PM — 3:00 PM

Managing in Complexity: Emergency Use Authorizations Process and COVID-19 Lessons Learned

DIA 2021 Global Annual Meeting

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