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PhIRDA Successfully Nominates Five Experts to IFPMA ICH Expert Working Groups
News & Events PHIRDA 2025.03.28 55

From November 2 to 6, 2024, the ICH Assembly was held in Montreal, Canada, and several ICH Guidelines entered different revision stages. Entrusted by IFPMA, PhIRDA successsfully nominated five experts to participate in relevant IFPMA ICH Expert Working Groups (EWGs). These experts deeply involved in the development, revision, and implementation of ICH Guidelines, making significant contributions to the harmonization of international regulations. Below is the list of EWGs and experts:

No.

IFPMA ICH EWG

Name

Company/Institution and Position

1

M15: General Principles for Model-Informed Drug Development

ZHENG Shansong

Director Clinical Pharmacology,Qilu Pharmaceutical Co., Ltd.

2

Q1/Q5C: Targeted Revisions of the ICH Stability Guideline Series

ZHANG Xingyi

Vice President, Head of Regulatory Science, Simcere Pharmaceutical Group limited

3

SHEN Zhenduo

Director of Analysis, Shandong Boan Biotechnology Co., Ltd.

4

Cell and Gene Therapies Discussion Group

CAO Xiaoping

Vice President, China Technical Operations, Legend Biotech

5

KONG Yan

Site Quality Head, FosunKite

As of January 2025, PhIRDA has nominated 60 experts (including 11 Leads and 9 Alternates) to 29 IFPMA ICH EWGs, accounting for 37% of the total global IFPMA experts. The experts nominated by PhIRDA have been actively engaged in international regulatory rule-making, demonstrating the professional expertise and innovation capabilities of China’s pharmaceutical industry.

In the coming year, PhIRDA will remain committed to its mission of “Innovation, Industrialization, and Internationalization”, further deepening cooperation with IFPMA, and representing the Chinese pharmaceutical industry in the development and revision of international regulations. PhIRDA will continue to contribute to the high-quality development of global pharmaceutical innovation.

2025 ICH Assembly and Meetings Schedule

Event

Time

Location

ICH Interim Meeting

March 13-16, 2025

Budapest, Hungary

ICH Assembly

May 10-14, 2025

Madrid, Spain

ICH Assembly

November 2-6, 2025

Singapore

 

Click to see PhIRDA IFPMA ICH Expert List