Announcement of CQAF Core Team 2018-2020

Dear all CQAF members,

We are pleased to formally introduce *Amy JIANG, Heidi(Haitao) LIU, Cathy(Qingyue) LIU, Ellyne SETIAWAN, Yifeng SHEN, Sean (Xiaogang) XU, Guiqin YU, Liping ZHOU to the Core Team of China QA Forum (CQAF). All members have been actively involved in CQAF activities in the past years and are willing to devote their expertise and time for facilitating CQAF further development.

Hannah CHEN and Lanjing ZHANG will continuously support CQAF as the Legal Representative and the General Secretary.

  Cathy (Qingyue) LIU, Chairperson, Shanghai

Cathy currently holds the position of Site Head for Roche Pharma Development Quality (PDQ) Asia Pacific, and Principle Portfolio Lead for Roche Pharma Development Quality Strategy. Cathy’s primary responsibilities are to assure the realization of the Process and Pipeline QA strategies for key process areas and molecule programs in a global landscape. 

Have been working in pharmaceutical industry for more than 20 years, Cathy had increased responsibilities within clinical operations at MNCs before she joined Roche. She started as the Function Head of Compliance & Training to drive the quality management strategies and activities for Roche Pharma Development Center in China, and has extended to Global Quality Assurance of conducting GxP audit programs in the areas of GCP/GVP/GCLP since 2009.

Joined CQAF from the foundation, Cathy has been worked as CQAF core member from 2016 to 2018 and  now the CQAF Chairperson for 2018-2020.

 Amy (Yanmin) JIANG, Core member, Shanghai

Amy is a MD by training and graduated from Jiaotong University Medical College (former Shanghai Second Medical University) and then practiced as an Oncologist in Pulmonary Department at Shanghai Chest Hospital for 5 years. She has been in the Sanofi Company since 1999 in various positions with increasing responsibilities, involving in clinical operations and quality operations and site operations in R&D. She has ever been responsible for several global mega trials in different therapeutic areas and for GxP quality management system setting up and maintenance in China R&D. 

 Heidi(Haitao) LIU, Core Member, Shanghai

HAITAO (HEIDI) LIU, medical background and started her career as a general physician. Once she completed Master Degree in International Public Health in 2004, she moved to the field of clinical trials. This has included experience as a contract monitor and auditor for WHO TDR’s projects, Medical Officer of Forum of Ethical Review Committees in Asian & Western Pacific Region (FERCAP), Training and Compliance Officer in the Clinical Research Institute of Shanghai Huashan Hospital, the Office Director for Peking University Institutional Review Board.  Since 2012, she has been working as GCP Compliance and Quality Assurance professional in industry.  With a lot of “it depends” in QA’s daily work, she believes reasons and meanings are essential for justification, and compliance should be anchored on universal ethical principles.

 Ellyne SETIAWAN , Core Member, Shanghai

Ellyne is from Singapore and works in the clinical research industry since 1998; spending most of her time in clinical operations across Asia, MENA and Europe holding various positions before moving into quality management. Currently, she is leading the Quality Medicine function in Boehringer Ingelheim’s Chinese Markets. Together with a team of highly dedicated and dynamic quality professionals, they drive quality culture, compliance, improvements, knowledge and learnings with passion within the organization. Ellyne joined CQAF at the start of Y2015 and has since been actively contributing to and supporting a number of CQAF priorities. She is guided by a set of personal values of being fair and transparent as well as the working principles of open communication and team work.

 Dr. Yifeng SHEN, Core Member, Shanghai

Dr. SHEN, Yifeng received B.S.Med. (1996) from Second Military Medical University, M.S.Med. (2002) and Ph.D. (2011) in psychiatry from Fudan University. In 2009, Yifeng became a CPI® of ACRP. 

He is now an associated chief psychiatrist, director of GCP office, QA team leader and IRB member of Shanghai Mental Health Center. He also is minor head the National Science and Technology Major Project (NMP) for IND in psychiatry (2008-2020), the leading GCP platform in China with more than 20 million RMB government grant. He was elected an external reviewer of Center for Drug Evaluation of CFDA from Jan. to Jun. 2012. He is one of CDE reviewer experts and GCP inspectors of CFDI.

 Sean (Xiaogang) XU, Core Member, Beijing

Sean holds a bachelor degree in Clinical Pharmacy from China Pharmaceutical University and a Certificate of Completion of Master Courses in Project Management from Graduate University of Chinese Academy of Science. 

Sean is currently working for Zigzag Associates Ltd., a global GxP QA Services Provider, as Associate Director of QA Services for Asia Pacific. He is a highly experienced professional with significant operational, project/people management and QA experience within the pharmaceutical and medical device industries since year 2003, for both MNCs and CROs. Expertise in GCP auditing across a wide range of audit types including clinical investigator site, vendors, systems, documents, affiliates and internal departments in Asia Pacific area since 2010. Proactive and with excellent managerial skills, he has led both global clinical trials and those local to the Asia Pacific region, from start-up to close-out, and in a wide range of therapeutic areas. Sean joined CQAF in year 2012 and has been actively participating in and supporting CQAF initiatives and training programs. 

 Guiqin YU, Core Member, Beijing

GUIQIN YU was graduated from the Beijing Medical University in Jul 1998 with master degree of Gynecology & Obstetrics.

Guiqin currently holds the position of head, GCP Study Audit Management Asia Pacific, Research & Development Quality, at Bayer Healthcare, with managerial responsibility for the Senior/Global Clinical Auditors, and 2nd level line managers, located in Asia Pacific including Japan, and has extensive clinical quality assurance auditing experiences covering mainly for GCP audits such as investigator site, supplier and document audits, but also has experience of GLP audit, process audit and medical affiliate audits in Asia Pacific and at global level.

Guiqin has 9 years working experience in the area of quality assurance and 17 years in Clinical Research area.

 Liping ZHOU, Core Member, Beijing

LIPING ZHOU is currently working for MSD Research Laboratories (MRL) as QA director for Asia Pacific. Having worked for multi-national pharmaceutical companies for over 16 years, Liping developed her QA profession in Bayer since 2009 with increased scope and responsibilities in the area of GxP audits and inspections worldwide. 

Joined CQAF from the foundation, Liping has been worked as CQAF core member since 2012 and lead CQAF activities as chairperson for the third term (2014-2016). Liping graduated from Peking University Health Science Center (Previously named as Beijing Medical University ) in 1999 and worked in Beijing Cancer Hospital before joining the industry. Liping values Integrity and Diligence, and leads with openness, respect, fairness and flexibility.

 Hannah(Hua) CHEN, Legal Representative, Beijing

HANNAH is currently Quality Strategy Lead for Asia Pacific responsible for development and strengthening the QMS in Janssen Pharma R&D. She used to be the AP QA Director leading a team of auditors based in Asian countries covering non-regulated, GLP, GCP, and Pharmacovigilance (PV) audits. She has 15 years in the area of compliance and 5 years in Clinical Research. Hannah worked as a Pediatrician for years before joined the industry in 1996.

Hannah is the originator and founded the CQAF in May 2010 and chaired forum from May 2010 to May 2012. She continuously supported CQAF development and sponsor several projects in the forum.

 Lanjing ZHANG, General Secretary, Shanghai

LANJING holds a Master’s degree in Physiology, Soochow University, and currently is Medical Quality & Training Manager in Roche Pharma., supporting continuous improvement in local Quality Management System in GCP and GVP activities in China since 2011. Before that she works in clinical research and medical department in Covance and CP-GJ pharma. for 5 years, and as general practitioner for 5 years. 

LANJING join in China QA Forum as General Secretary since Feb 2012, with the responsibility to support CQAF Chairperson and Core Team to ensure the CQAF daily work run smoothly.

*According to the sequence of the surname

Thanks for your attention and please share with us your thoughts via the following survey. Looking forward to hearing from you

https://www.wenjuan.in/s/6fmQzuc/

Warm regards

Cathy (Qingyue) Liu

Chairperson of CQAF