In this issue:
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2014 ISPE China Annual Spring Conference-Register now
•
2014 ISPE Trainings are coming soon
•
ISPE will join the CIPM this April
•
Mar-Apr member gift package is available now
•
ISPE Manufacturing and Engineering Committee Introduction
•
ISPE Clinical Supplies Committee Introduction
•
Featured Stories - Volunteers
•
ISPE Volunteers recruitment
Events:
2014 ISPE China Annual Spring Conference-Register now
2014 ISPE China Annual Spring Conference is coming soon this April 21-22 in Shanghai. Join us to
hear the cutting-edge information / knowledge and best practice (e.g. Generic Product Development &
Quality and development of monoclonal antibodies based biosimilar) from 60+ industry leaders and
experts from Pfizer, Novartis, Bayer, Merck, Hengrui, Amgen, Hisun, GSK etc. Furthermore, the
regulatory officials from FDA and CFDA will also present their perspectives regarding to GMP
inspections.
Download Conference brochure!
Speakers at a glance
Hao Cui | CFDA
Yamin Wang | CDE, CFDA
Zhaoguang Yan | FDI, CFDA
Jianzhao Niu | NIFDEC
Piaoyang Sun | President, Hengrui
Michael Choy | Managing Director of Boston Consulting Group
View more speakers
Meanwhile, ISPE will organize facility tours to GE Healthcare Shanghai and Genor BioPharma Lab in
Apr 23 morning , which are only open to ISPE members that attend the conference. Please email to
China@ispe.org with your name, company, email, mobile number, and which plant you want to visit.
The registration will end Apr 18. Click here to know more concurrent events during the conference.
Download the Sponsorship plan to showcase Your Products and Services at the most influential
event!
2014 ISPE Trainings are coming soon
Under the guidance of ISPE training committee, ISPE will initiate a training week on July 21-25,
including a series of courses e.g. Quality Risk Management, OSD, GMP Auditing, Part 11+GAMP5
etc.
ISPE has always committed to involve experienced industry experts to deliver the systematic
knowledge, best practices and POVs to trainees, and improve their mastery of various skills.
From the trainees:
“In the OSD training course, I learn the basic process and technology knowledge, and understand the
influential factor to quality as well as the knowhow to improve it. I certainly benefit from the instructor’s
rich experience, knowledge and POVs. I hope ISPE would deliver more valuable courses and latest
technology to more pharm professionals.” Mr Zhou, Roche
“In Quality Risk Management training course, the instructor delivered a comprehensive, systematical
and in-depth knowledge. It provides us with a guidance of future work. I wish ISPE could deliver more
similar course to build the learning platform for pharm industry. And we are glad to participate in more
ISPE activities." Ms Sun, China Resources Double-crane Pharmaceutical Co.,Ltd.
ISPE will join the CIPM this April 24-26
ISPE will join the 47th China International Pharmaceutical Machinery Exposition (CIPM) in Wuhan this
Apr 24-26. In Apr 25 morning, ISPE experts will give the presentations of “The Automation Framework
of Modern Plant”, “The Confusion and Breakthrough of GMO” and “Cleaning Validation” in B2-2
meeting room of B3 Pavilion. Welcome to join us and exchange the thoughts and experience with
ISPE experts.
ISPE Member Zone:
Mar-Apr member gift package is available now
As one of key membership benefits, Monthly gift includes the hot information, frontier technical
articles and industry reports around the globe. Meanwhile, ISPE China also provides ISPE members
with a local monthly gift including local valuable contents/knowledge. ISPE members are able to
download this gift package at the beginning of every month on ISPE China Official Website.
HQ’s monthly gift（These will be available to you by Apr 30, 2014)
• Pharmaceutical Engineering May/June Issue Preview: "Defining Holistic Asset Criticality to Manage
Risk"
• Statistically Determined Acceptance Criteria and Sampling Plans for PPQ"
China’s monthly gift - 2013 ISPE China Annual Conference presentation slides (2)
（ These will be available to you by May 7, 2014 )
• China Generic Drug Marketing Access System
• DQ and QRM-basis Engineering Design of Biopharmaceutical Project: Case study
Notice: Don’t miss your membership benefits.
ISPE Committees and Activities:
ISPE Manufacturing and Engineering Committee Introduction
The main work of the committee involves active pharmaceutical ingredients, chemical and biological
drug related to engineering and production. It aims at promoting engineering guidance (Baseline &
Good Practice) which published by ISPE applied to facility design, construction and manufacturing etc.
At present, the committee sets up three branches including Sterile Subcommittee, Oral Solid Dosage
Subcommittee and Critical Utilities Subcommittee.
ISPE Clinical Supplies Committee Introduction
Clinical Supplies Committee aims at discussing the current clinical common challenges in supply
chain industry and sharing their experience; sharing the latest information on clinical supply chain
management with regulatory agencies; and choosing appropriate training courses catering to the
needs of Chinese pharmaceutical industry.
Featured Stories - Volunteers
With volunteers’ substantial support, ISPE has made gigantic progress in China. We are appreciated
for their efforts in promoting ISPE.
Mingping Zhang: ISPE Regulatory and Compliance Committee Member; Senior CMC director,
BeiGene Beijing. He actively involved in committee’s activities; drafted and summarized the research
lunched by ISPE Regulatory and Compliance Committee, and shares latest international / domestic
regulations information with other ISPE members.
Cindy Shen: ISPE Regulatory and Compliance Committee Member; ISPE Training Committee
Member; Conference Committee Member; Chief technical adviser, Roche Shanghai.She plays the
multiple roles in ISPE events, including the speaker of ISPE China Annual Conference, the moderator
of ISPE ICH Q10 Conference, and the instructor of ISPE Training Course-GMP Auditing. In addition,
she helps to advance the relationship between ISPE and Chinese Regulators.
Bin Yang: ISPE China Student and Young Professional Committee Member; Senior manager of
Emerson Process Management. He made a great contribution to the translation of ISPE technical
guidance and PE articles, and is responsible for promoting ISPE content’s sharing through ISPE
online forum as the moderator.
Hong Lin: ISPE China Board Member and Chair of ISPE China Training Committee; Director Life
Sciences Vertical from MES, Siemens Industry Software (Shanghai). She is the first qualified Chinese
instructor from ISPE in China, and led the translation & publishing of ISPE technical document –
GAMP 5.
Here, we’d like to thank all these fellows and will introduce more volunteers in future.
ISPE Volunteers recruitment
Volunteers always play a vital role in ISPE’s development. You can join ISPE committees, the task
group, or community discussion groups to be our volunteers, and share your knowledge, experience
and perspectives with others. (ISPE member only) ISPE is now recruiting the volunteers for ISPE
pharmaceutical engineering magazine articles’ translation. Volunteers should have relevant
knowledge and background.
If you want to join us, please contact Viona: 021-2312-3521 or email china@ispe.org .