Dear CQAF member,
Thank you being with us China Quality Assurance Forum (CQAF ) in the past 13 years . As the leading exchange platform for quality professionals in the pharmaceutical industry in China, China Quality Assurance Forum has been led by the founder, successive chairmen, core team, and industry leaders. And with the support of members, relevant industry associations and platforms, and the promotion of diversified cooperation, our organization continues to improve and optimize on the road of supporting and contributing to the healthy development of the industry. Today, in the beautiful autumn season, we also ushered in the core team for the new term (2023-2025) , and we are very happy to announce:
In the new term, Ms. Zhang Ping will serve as the chairperson of CQAF . Ms. Liu Qingyue, Dr. Shen Yifeng, Mr. Xu Xiaogang, Ms. Yu Guiqin, and Ms. Zhou Liping will continue to serve as core team members. At the same time, Ms. Wu Yiqing and Ms. Liu Yanping are welcome to join the CQAF core team . The new core members have made outstanding contributions in leading the sub-committee work of CQAF GVP and GCLP in the past few years , and they will play a greater role in the core team and professional fields. The previous core members, Ms. Jiang Yanmin, Ms. Liu Haitao, and Ms. Ellyne Setiawan, who have contributed outstanding leadership to CQAF and the industry , will form the CQAF senior advisory group to continue to support and contribute. In addition, Ms. Chen Hua and Ms. Zhang Lanjing will continue to serve as CQAF legal persons and General secretary. The new term will take effect from October 1 , 2023 . A detailed introduction to the core team is provided below.
The healthy development of the industry is closely related to each of us. To do quality work well requires professional skills, an open attitude, an inclusive mind, excellent cooperation, and a spirit of continuous improvement that meets business purposes. Please continue to join hands with us, we will learn and grow together under the leadership of the new core team , and further contribute to the quality improvement and internationalization of the Chinese pharmaceutical industry.
Sincerely
CQAF core team
Note: 1. Sort by the first letter of the last name
Sally (Ping) ZHANG, Chairperson, Shanghai
Sally has been a member of CQAF since its inception and began her QA career with Pfizer Global Quality Assurance in 2010 . Her previous work experience also includes working in clinical operations at AstraZeneca China Research and Development. After Pfizer, she served as Vice President of Quality Management at CStone Pharmaceuticals, a Chinese biopharmaceutical company, where she led the establishment of the company's clinical quality management system and the implementation of quality management strategies for three years. Since the beginning of 2021, Sally has served as the Asia Pacific Head of AstraZeneca Global R&D Quality Assurance as a member of the R&D management team. Her team is responsible for the organizational quality management strategy, GxP audits and pharmaceuticals in the Asia Pacific region including R&D centers in China and Japan. Political inspection management and other work.
Sally was an otolaryngologist before joining the pharmaceutical industry. She graduated from West China Medical School of Sichuan University and obtained a postgraduate degree from a joint master's degree program between China and Dalhousie University in Canada.
Since 2019, Sally , as an expert representative of the Chinese industry and the leader of IFMPA , has been engaged in the global transformation of ICH GCP R3 in the ICH global expert group.
Cathy ( Qingyue ) LIU, Core Member, Shanghai
With more than 25 years of experience in the pharmaceutical industry, he has served in the pharmaceutical R&D departments of Eli Lilly, Glaxo and Roche in clinical trial operations, quality and training and quality assurance management. Audit experience covers the fields of GCP, GCLP and GVP, and the audit areas include countries in the Asia-Pacific region, Europe and the United States.
Currently the head of the Asia-Pacific region of Fortrea's Clinical Quality Assurance Department (excluding India). He mainly leads the Asia-Pacific audit/inspection management team to complete audit and verification support work in the Asia-Pacific region and globally, and improves quality through cooperation with business departments, and deeply enhance the quality culture in daily work and the continuous improvement of quality management system.
In addition, actively participate in and promote the quality of clinical trials in China. Joined the China Quality Forum since its inception and has served as a CQAF core team member since 2016 and Chairman(2018-2020)of the China Quality Forum.
Liu Yanping Tracy ( Yanping ) LIU, Core Member, Shanghai
Graduated from China Agricultural University majoring in animal medicine. Currently working at Lapcorp , he serves as the Asia Pacific Central Laboratory QA Director and Global GLP QA Director. Mainly engaged in the management of QA teams in central laboratories, bioanalytical laboratories and non-clinical safety evaluation research institutions. Previously, he worked in the pathology laboratory, veterinary team, subject leader (SD), and QA department of Charles River, Bioduro, and Bridge Laboratory. Familiar with the quality system construction in GLP and GCLP subject areas and the key points of inspection by regulatory agencies in various countries.
Tracy led the team to create CLQA (Clinical Lab Quality Alliance) in 2018, which is committed to improving the quality system construction in the laboratory field and gathering quality assurance personnel in related fields. GLQA became the GCLP sub-committee of CQAF in 2019.
Dr. Yifeng SHEN, Core Member, Shanghai
Bachelor's degree from the Second Military Medical University (1996), Master's degree (2002) and PhD (2011) from Fudan University Shanghai Medical College. American Association of Clinical Research Professionals (ACRP) Certified Research Physician (2009~). Rutgers New Jersey Medical School Senior Visiting Scholar (2015-2016)
Chief physician, institutional director and ethics committee member of Shanghai Mental Health Center. Deputy team leader of the GCP Platform for Psychotropic Drugs, a major national science and technology project for “Major New Drug Creation” (2008~2020). Drug review expert of the State Food and Drug Administration, distinguished expert of the Institute of Advanced Research and GCP inspector. Evaluation expert of the Human Genetic Resources Management Office. Vice Chairman of the Special Committee on Drug Clinical Evaluation and Research of the Chinese Pharmaceutical Association.
Winne(Yiqing) Wu , Core Member, Shanghai
Nearly 20 years of working experience in the pharmaceutical industry, including more than 15 years of pharmacovigilance work experience and work experience in different fields such as clinical trial operations and medical communication. He has served as director/head of pharmacovigilance departments in many companies, including AstraZeneca, Celgene and Boehringer Ingelheim. Currently, he is the Head of Medical Operations Excellence at Boehringer Ingelheim.
One of the authors of "GVP Guidelines for Drugs" and "Pharmacovigilance Practice"
Sean (Xiaogang) XU, Core Member, Beijing
Master of Engineering in Project Management from the Graduate School of the Chinese Academy of Sciences and Bachelor of Clinical Pharmacy from China Pharmaceutical University.
20 years of working experience in the pharmaceutical/medical device industry, including 10 years related to drug/medical device development project management: managing local/global clinical trials, organizing and managing in-house training programs for R&D related teams, managing cross-border Regional compliance projects, as well as planning and executing the deployment of quality management systems in the company's branches in the Asia-Pacific region. In the last 13 years, he has served as a multinational pharmaceutical/device company, a multinational/local CRO company, and a pharmaceutical audit compliance manager /quality assurance director/deputy director of QA services in the Asia-Pacific region, carrying out independent GCP audits and managing quality around the world. Assurance/Quality Supervision and Training/Quality Document Management Department, formulates business strategies for QA services in the Asia-Pacific region, etc., thereby contributing to the improvement of the quality and efficiency of the organization's business operations. Joined Beijing Xiaotong Mingda Technology Co., Ltd. in June 2021 and has served as partner, deputy general manager, and general manager/legal person. Responsible for company management, business development, planning and execution of QA outsourcing activities entrusted by customers. Xu Xiaogang joined CQAF in 2012 and actively participated in and supported activities and training projects initiated by CQAF. In terms of social activities, he currently serves as a distinguished expert at National Medical Products Adminstration Institute of Executive Development and a course lecturer at YEEHONG Business School.
Guiqin YU, Core Member, Beijing
Graduated from Beijing Medical University in July 1998 and received a master's degree in obstetrics and gynecology.
Currently serves as the Asia Pacific Executive Director of Clinical Trial Auditing at Bayer Healthcare Co., Ltd. Responsible for personnel management in the Asia-Pacific region (including Japan). He has extensive experience in quality assurance audits in the Asia-Pacific region and globally, including test center audits, supplier audits, document audits, process audits, department internal audits, GLP audits, etc.
Has 22 years of experience in clinical trials, including 14 years of experience in quality assurance. Actively participate in and promote the quality of clinical trials in China. Joined China Quality Assurance Forum since its inception, served as a member of the CQAF core team since 2016, and served as a course lecturer at the National Medical Products Adminstration Institute of Executive Development since 2015.
Liping ZHOU , Core Member, Beijing
Zhou Liping ( Liping ) is currently the Senior Director of Quality Assurance Department of Merck Research & Development (MRL) Asia Pacific. She focuses on cultivating and developing professional QA teams in the Asia Pacific region. Liping joined the pharmaceutical industry in 1999. After 10 years of front-line work experience, Liping has been deeply involved in the field of pharmaceutical research and development quality assurance (QA) since 2009, and has accumulated experience in domestic and foreign independent audits, as well as international drug regulatory inspections. For more than ten years, Liping has cooperated with industry experts, continuously participated in and led professional seminars on QA, cQMS and industry best practices, and is committed to promoting a healthy quality culture and a mature clinical quality management system.
Liping has worked in R&D institutions of multinational pharmaceutical companies such as Novartis Pharmaceuticals, Bayer Pharmaceuticals, and Merck & Co. R&D . She served as the third chairman of China Quality Assurance Forum (CQAF) and is currently a core member of CQAF and a member of DIA Advisory Committee of CHINA (ACC). Graduated from Peking University School of Medicine (formerly Beijing Medical University) in 1999
Hannah(Hua) CHEN, Legal Representative, Beijing
Independent GCP consultant. He has more than 20 years of experience in R&D work in multinational pharmaceutical companies, including clinical operations, quality assurance/GCP audits, quality management system establishment and training. He has been a GCP consultant since 2019.
Chen Hua founded the China Quality Assurance Forum (CQAF) in May 2010.
Lanjing ZHANG, General Secretary, Shanghai
Zhang Lanjing is currently the deputy director of Quality Medicine, The Chinese Market in Boehringer Ingelheim. She has been responsible for quality management of clinical trials and pharmacovigilance in China for Roche Pharmaceuticals for 10 years. Prior to that, she worked in the clinical research and market medicine departments of domestic pharmaceutical companies such as Covance and CITIC Guojian for 5 years respectively, and serve as a general practitioner for 5 years.
Zhang Lanjing joined the China Quality Assurance Forum (CQAF) in February and served as General secretary since 2012.
CQAF senior advisory group
Amy (Yanmin) JIANG, Advisory group member, Shanghai
Has over 20 years of experience in the pharmaceutical industry. Joined Harbour BioMed in November 2019 and is responsible for the construction and maintenance of GxP quality management system. Previously, he had been serving the China R&D Center of Sanofi. He was responsible for coordinating the daily local operations and global large-scale activities of the China R&D Center, and maintaining the interaction within and outside the China R&D Center. She was responsible for the GxP quality management system and operations of the China R&D Center for seven years; She has been engaged in drug clinical research and operation for ten years, and has successfully led several large-scale clinical trials in different therapeutic areas such as oncology and cardiovascular disease.
Before joining the pharmaceutical industry, he had five years of experience as an oncologist in a tertiary hospital in Shanghai. Graduated from Shanghai Jiao Tong University School of Medicine (formerly Shanghai Second Medical University) majoring in clinical medicine.
In addition, he is enthusiastic about promoting the development of clinical trials in China. Internally, the company is responsible for coordinating clinical research-related training for hospitals. Externally, she is a core team member of the China Quality Assurance Forum (CQAF); he serves as a distinguished expert at National Medical Products Adminstration Institute of Executive Development and a course lecturer at YEEHONG Business School.
Liu HaitaoHeidi(Haitao) LIU, Advisory group member, Shanghai
Liu Haitao, with a medical background, started her career as a general practitioner. In 2004, after receiving a master's degree in international public health, she transitioned into the field of clinical trials. These include serving as monitors and auditors for the WHO TDR project, medical officer of the Forum of Ethical Review Committees in Asia and the Pacific (FERCAP), responsible for the training and compliance work of the clinical research institution of Shanghai Huashan Hospital, and director of the Ethics Committee Office of Peking University. Since 2012, he has worked in GCP compliance and quality assurance in pharmaceutical companies. In 2020, he joined Swiss Widler & Schiemann Pharmaceutical Consulting Company as a quality management & quality assurance consultant. There is a lot of "it depends" in QA's day-to-day work, and she believes that reasonableness and meaning are necessary conditions for legitimacy, and that compliance should be based on universally recognized ethical principles.
Ellyne SETIAWAN , Advisory group member, Singapore
Ellyne Setiawan is currently Head of Clinical Quality Assurance for Eisai Asia Pacific. She has worked in the clinical research industry for over 20 years and is an experienced quality leader with extensive expertise in GxP quality for drug development. She has extensive background and experience in transforming organizational quality management systems and quality cultures, quality remediation, audits, inspections, supplier management, issue and risk management. In the past, she has also held leadership roles in clinical operations and pharmacovigilance.
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