DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate

The ICH improved global drug development, but rising country-specific regulations increase complexity and costs for multinational submissions. This session explores key harmonization challenges, regulatory trends, and strategies to navigate diverse requirements for successful drug approvals.

Learning Objectives

Identify the similarities and differences in how major global regulators (FDA, NMPA, PMDA, EMA) engage with sponsors throughout the drug development lifecycle; Analyze key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways among different regulatory agencies; Gain practical insights into navigating global landscape.

Chair

Steve Sibley, MS

Speaker

After Years of Harmonization, Country Regulations are Diverging and Simultaneous Global Submissions are Becoming Difficult
Steve Sibley, MS

Global Regulatory Communication Practices with Sponsors: A Comparative Analysis
Natalie Tolli, MS, RPh