Online Event: 21 November 2022 – 13 January 2023
Time: 4:00pm ~ 6:00pm, 08 Dec. 2022 (UTC+8 China Time)
Language: English
Organizer: CPHI & PMEC China
Co-organizer: IPEC China
Sharing on ICH Q3C Implementation of Excipient Standards in China
- ICH Q3C Introduction
- Comparison of USP/EP/ChP on implementation of ICH Q3C
- The plan of ChP to further implement ICH Q3C for excipient standards
Comparison of Chemical Drug Substance and Pharmaceutical Excipient Registration in China
- Discuss similarities and differences between drug substance and pharmaceutical excipient registration in China in terms of submission content, registration fee, registration process and so on.
Comparison of China Excipient GMP and IPEC PQG GMP
- Brief introduction of Chinese regulation on excipient manufacturing
- Brief introduction of China and IPEC-PQG GMP
- Key comparison of China and IPEC-PQG GMP
Overview of Excipient Regulatory Requirements under Bundling Review Policy
- Since the implementation of the bundling review policy in 2016, the regulations and requirements have been continuously improved, and the industry's understanding and participation enhances. IPEC China hopes through this CPhI meeting to share an overview of the regulatory requirements for pharmaceutical excipients under the bundling review policy, from the aspects of excipient China DMF, registration specification, excipient production supervision and change management of excipients.
Soya Song
Regulatory Expert, Merck Chemicals
Graduated from China Pharmaceutical University, Licensed pharmacist. 17 years quality assurance and regulatory affairs experience in MNCs company. Familiar with China, US and EU quality management systems, API & Excipients regulatory requirements and registration affairs.Regulatory Expert of Merck Life science.
Focus on regulatory strategy research (CDMO and CGT), Responsible for regulatory support, API & Excipients registration affairs and the improve advocacy of excipients standards of Chinese pharmacopoeia. From 2020, I have participated in the ICH Q3C & Q3D Project which have to harmonized with Chinese Pharmacopoeia excipient standards on behalf of IPEC Association.
Lina Li
Stewardship Registration Manager, Clariant Chemicals Technology
Graduated from Pharmaceutical Engineering, Zhengzhou University in 2005; 17 years of working experience in the pharmaceutical industry, including quality management, GMP audit and registration of pharmaceutical excipients in China and registration of drug substances in China and aboard.
Since 2019, work in Clariant Chemicals Technology (Shanghai) Ltd., responsible for registration of pharmaceutical excipients in China and drug substances in China and aboard. IPEC Regulatory Affairs Subcommittee Member.
Shine Gao
DKSH China PHI Supervisor, DKSH Performance Materials China
Graduated from China Pharmaceutical University in 2010, majoring in Pharmaceutical Analysis, with 8 years of quality management experience in drug manufacturing company, familiar with pharmaceutical GMP quality management system. In 2018, I entered the excipient industry, mainly responsible for China CDE registration, the quality and technical support, establishing the quality management system of excipient distribution. In 2020, I served as the chairman of quality Sub-Committee of IPEC China. In April 2021, I worked part-time as a technical expert in DQS Shanghai to participate in the third-party certification audit. In July 2022, I joined DKSH China and am responsible for quality, regulatory support and market development of excipient.
Li Chunhong
Regulatory affairs supervisor, Suzhou Capsugel Limited
Has 7 years of experience in regulatory affairs since graduation from China Pharmaceutical University in 2015. Joined Suzhou Capsule Limited (a Lonza company) in 2018, responsible for China CDE registration of domestic and imported excipients, regulatory affairs handling and regulatory support to customers. Before entering the excipient industry,I used to work in pharmaceutical company for drug registration for 3 years and familiar with the regulatory requirements and procedures related to drug registration in China.
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