The second day will focus on the role of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in strengthening regulatory systems and supporting the global development of safe, effective, and high-quality medicines.
Participants will hear practical perspectives on the value of ICH membership, the pathway toward membership, and the experiences of regulatory authorities across Asia. The program will also highlight how capacity-building partners can support implementation of internationally harmonized guidelines and strengthen regulatory systems through sustained collaboration.
A dedicated session on evolving Tier 1 guidelines will examine the implementation of ICH E6(R3) and recent developments related to the ICH Q1 guideline. Discussions will highlight key concepts, implementation considerations, and the potential impact of these guidelines on regulatory authorities and industry, while promoting greater understanding and convergence across regions.