Day 4 - Asia Regulatory Conference

07:30 - 08:15 CET / 17:30 - 18:15 AEDT

Session objectives:

Emphasize the importance and benefits of ICH Membership
Present the IFPMA role in ICH, underlining the involvement of Asian experts in IFPMA Task Forces.
Share a Success Story of a National Regulatory Authority (NRA), illustrating the process and the benefits realized.

Moderator
- Kum Cheun Wong Head Asia Pacific Regulatory & Development Policy, Novartis Asia Pacific Pharmaceuticals Pte Ltd
Presenters
- Su Jin Kong Special Expert in International Regulatory Affairs and Representative to ICH, Ministry of Food and Drug Safety (MFDS), Republic of Korea, Ministry of Food and Drug Safety (MFDS), Republic of Korea
- Angelika Joos Executive Director, Merck Sharp & Dohme (MSD)

08:15 - 09:15 CET / 18:15 - 19:15 AEDT

Session objectives:

Understand the current status of eCTD implementation in Asia.
Feature best practices and highlight the importance and benefits of harmonizing eCTD.
Discuss strategies and recommendations for implementing eCTD in line with international harmonization.

09:15 - 10:30 CET / 19:15 - 20:30 AEDT

Session objectives:

Comprehend E6(R3) Guideline Revisions: key updates in E6(R3) and their significance for enhancing clinical trial practices and aligning with international standards.
Analyze Regulatory Preparations: how different regulatory authorities are preparing for the implementation of E6(R3).
Explore Data Integration: Consider the impact of E6(R3) on the use of Real-World Data (RWD) and Real-World Evidence (RWE), including the associated challenges and opportunities.

ICH day