July-August,2011
-Last “GMP Auditing” Training in Aug. Don’t miss it!
-ISPE-CCPIC China Conference 2011: Register Now!
-Join ISPE Annual Meeting 2011 in Texas
-2011 ISPE Facility of the Year Awards
-ISPE new publication: Process Gases
-ISPE Indonesia Affiliate delegates visits China
- ISPE calls for Chinese version of new tagline
-A kind reminder: Update your membership information on ISPE website
-ISPE China Poster Competition
-ISPE China online COP calls for volunteers
-ISPE Offline COP event announcement
-ISPE committee introduction-Regulatory Committee
Last “GMP Auditing” Training in Beijing in Aug 15-16. Don’t miss it!
ISPE China will organize the “GMP Auditing for the Pharmaceutical Industry” Training on August 1516 in Beijing. This is your last chance in 2011 to discuss GMP related topics with ISPE prestigious
GMP experts Rory Budihandojo as well as industry professionals like Xu Qiaoping (Pinky Xu), Qin
Yihui (Jack Qin) face-to-face. The course will be delivered in Chinese and will mainly focus on
Preparation for an EU/US GMP Audit & Points to Consider in Conducting the Audit. Handouts and
hardcopy of presentation will be distributed both in English and Chinese version during the course.
Certificate will be issued after attending the training.
It is a wonderful opportunity for GMP auditors, quality control and validation professionals to
understand the GMP knowledge and international GMP Concept so as to adopt it into the
implementation of new GMP compliance. Know more about GMP Auditing course, please click here.
ISPE China so far has launched A series of curriculums designed to meet the needs
of the Chinese pharmaceutical industry in the second half of the year
2011. The topics include “Sterile Drug Manufacturing Facilities”, “Drug Manufacturing Facility Design
and Development”, “Cleaning Validation”, “Oral Solid Dosage Forms”, etc. More than 60 delegates
got involved in each training. ISPE trainings aim to help pharmaceutical professionals to get updated
on most recent industry trend, understand international best practices, and meet top experts in the
industry. Undoubtfully, it is also a great time to recharge your pharmaceutical knowledge. For more
ISPE Training information, please click here.
The latest curriculum notice:
Application of Commissioning and Qualification: Applying the Commissioning and Qualification
Baseline® Guide Principles.
This course is designed an advanced course and will be lectured by Robert Steen in English in Dec
2011, Shanghai. For more course info, please visit here.
ISPE-CCPIC China Conference 2011: Register Now!
ISPE-CCPIE China Conference 2011 will be held on October 25 -28 in Shanghai, InterContinental
Shanghai Expo-Shanghai,China. As a grand gathering of Chinese pharmaceutical elites, it will be
themed as "The New Age in the Chinese Pharmaceutical Industry – come and get world class best
practice.” The SFDA, FDA, WHO officials, industry leading experts will be invited to bring high-quality
keynote speeches. The market analysis of pharmaceutical industry will also be included. The
breakout sessions include “Sterile in a quality efficient way”, “Critical Utility”, “Quality System”, “C&Q”
as well as “OSD”.
This year’s conference will bring the most cutting-edge information and practical case studies through
various breakout sessions, the Leadership Forum, the facility tours and accordingly provide an open
platform for global knowledge and experience exchange.
Breakout sessions contain the following in the agenda:
● OSD (Oral Solid Dosage Forms)
● Critical Utility - high quality, low cost and Green
● Sterile in a quality efficient way - in compliance with new GMP
● Quality system - key to the effective Quality management system
● Fast from construction to Market - time is money
In the 4-day event, not only are delegates able to learn the latest trends of pharmaceuticals industry,
but also can they network with other industry counterparts. ISPE-CCPIE China Conference 2011 now
is open for registration. Click here to view annual conference schedule
Join ISPE Annual Meeting 2011 in Texas
ISPE Annual Meeting 2011 will be held on 6-9, Nov, 2011 in Grapevine, Texas, US. Themed in
“Preparing Professionals and Organizations for Rapid Change”, the event will take you to the future of
Pharmaceutical Industry and discuss how professionals and organizations deal with the rapid change
of the industry.
To attend this annual meeting, you can not only broad your views and get most practical knowledge,
but also get touch with governmental official, industry leaders, as well as peers of pharmaceuticals
industry.
It also provides a platform for enterprises who want to develop its international market. More than
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1000 participants have attended last year’s annual conference. Before 6 , Aug, you will get $200
disount for register booth. By sponsoring the event, enterprises can target their audience from
worldwide.
If you are willing to take part in this annual meeting, please contact us :china@ispe.org
2011 ISPE Facility of the Year Awards
ISPE “Facility of the Year Awards” will be announced during ISPE annual meeting. If your company
hope to present your facility design work and get recognition by international experts, please don’t
miss out this opportunity. The aim of this event is to set up a platform to enhance the level of facility
design, operation, as well as the development and application of the latest technology.
If your company would like to register this event, please click here to view the application form and
instruction. We look forward to seeing you in the ISPE annual meeting 2011!
ISPE new publication: Process Gases
ISPE has been dedicating to delivery pharmaceutical knowledge to all professionals and this industry.
ISPE publication is a critical and indispensible part of ISPE. Currently ISPE publications include “ISPE
Good Practice Guide, Baseline, GAMP”, etc.
A new ISPE book has been released in the “ISPE Good Practice Guide” series. The name of book is
“Process Gases”. The book aims to define current good practices within pharmaceutical
manufacturing applications, provide information to allow organizations to benchmark their practices,
and improve upon.
More about ISPE publications, please click here to view all names of ISPE publications.
ISPE Indonesia Affiliate delegates visit China
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In July 2011, 10 P-MEC China & CPHI China 2011 was held in Shanghai. During the event, ISPE
China Chairman Mars Ho and key committee members met ISPE Indonesia Affiliate delegates.
At the Welcome Reception, Mars Ho expressed his warm welcome to ISPE Indonesia delegates and
gave a brief about ISPE China. ISPE Indonesia Affiliate delegates introduced the current situation of
pharmaceutical issues in Indonesia. FDA officer Anrichu also exchanged his ideas about current
issues and the future of pharmaceutical industry.
ISPE calls for Chinese version of new tagline
This April, ISPE released its brand-new logo and tagline: Connecting a World of Pharmaceutical
Knowledge. The new tagline is delivering the messages of what ISPE does and how it does:
connecting a world of pharmaceutical knowledge through connecting peers, connecting organizations,
connecting volunteers, and connecting generations. By developing this new tagline, ISPE is evolving
and clarifying its role so that it is positioned to meet the needs of our members and the industry.
To help ISPE Chinese members better understand the new ISPE tagline, and to enhance its branding
in China, ISPE China office has translated the new tagline into Chinese. After discussion with ISPE
staff and committee members, three most popular translations are selected for all membership voting.
ISPE China members, now it’s your decision about which will be the ISPE tagline in Chinese. Click
here to join a poll to decide your ISPE Chinese tagline before August 20. ISPE China will announce
the final Chinese version of the tagline according to the final poll result.
A kind reminder: Update your membership information on ISPE website
One of the most important benefits for ISPE members is that ISPE provide member-only resources
and event information to its members through emails and phone calls, Therefore, a correct email
address or phone number will enable us to get these benefits to you. Recently, we realize a lot of
members’ contact information are out of date. We would like to kindly remind our members to update
your profile directly in ISPE website or send us your new contact information via email to
china@ispe.org.
ISPE China Poster Competition
Co-hosted by ISPE China and Sichuan University, ISPE China Poster Competition was launched in
June, 2011 and has so far received 47 pieces of posters from 11 universities. The Review Committee
of Poster Competition will start reviewing all the posters and 18 posters will be selected to join the
second round of evaluation. By the end of August, the top 6 poster writers will take part a video
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conference to give presentation. The 1 , 2 , 3 awards will be selected among the 6.
Emily Sun, staff project manager of the Poster Competition from ISPE China officesaid: “The Poster
Competition will not only give Chinese pharmaceutical students a great opportunity to integrated their
knowledge with practises, but also connect the relation between universities and industrial.
ISPE China online COP calls for volunteers
ISPE China is planning to set up a Chinese version of online discussion forum on the ISPE China
website. We would like to recruit volunteers from ISPE members to help with the topic selection and
translation work. As an ISPE member, you can log into the website to join the discussion forum ,
participating in discussions with other professionals on issues you encountered at daily work
time. What a volunteer needs to do is to select and translate good topics which you think is good for
the Chinese readers or moderate a topic sub-forum within the discussion forum. .
Currently, there are 8 topics selected by ISPE committees to be included in the discussion forum:
Sterile, OSD, GAMP, API, Biotech, PQLI, C&Q, Critical Utilities. You may choose from the above
topics and let us know what you would be interested to support.
Please contact Emily Sun from ISPE China office via phone call at 010-52061071 or email to
China@ispe.org with a resume attached.
ISPE Offline COP event announcement
Theme: 2010 GMP and QA/QC
Time: Sep 3, Saturday, 15:00-16:00
Venue: Beijing, detailed venue TBA.
Charge: free
Register: send email china@ispe.org or call at 010-5206 1071
Also, ISPE is calling for volunteer speakers and logistic supports to the organization of these events.
Email: china@ispe.org. or call 86+10+5206-1071
ISPE committee introduction-Regulatory Committee
In this issue informer, we would like to introduce Regulatory Committee. There are 7 members in this
committee. Members come from multi-national companies, medical monitoring organizations, as well
as consulting companies. The main function is to monitor national medical policies, give suggestions
to the topics of trainings and congresses as a medical monitoring side, also expand and maintain the
relation with governmental departments.
During the past 6 months, members of regulatory committee has engaged some projects, such as
planning of GMP forum, translation and proofreading for new GMP, as well as cooperation project
with government. Regulatory committee is aim to help ISPE and members to get to know the latest
pharmaceuticals policies, establish relation with government and industrials, guide ISPE to provide
services which fully understand the need of Chinese government and companies.