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翁新愚
国家食品药监督管理局,药品安全监管司,处长 |
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Clive BRADING,Senior Director in
PAREXEL Consulting's European team
Clive Brading joined PAREXEL Consulting in 2007. He
is currently a Senior Director in PAREXEL
Consulting's European team, leading about 100
consultant staff in the delivery of the PAREXEL's
Regulatory and GxP Compliance services to the
biopharmaceutical industry.
Mr. Brading's expertise is in manufacturing and
quality (GMP/GDP), with over 25 years experience in
the pharmaceutical manufacturing sector.
Mr. Brading has previously held Industrial Quality
and Manufacturing roles in pharmaceutical
organizations and has experience with all major
pharmaceutical dosage forms. This experience was
both at Corporate and Manufacturing site level, and
includes knowledge of manufacture and supply
requirements for all major markets, notably EU, USA
and Japan.
Prior to joining PAREXEL Consulting, Mr. Brading
worked for 5 years in a Corporate Quality role for
Sanofi-Aventis, based in Paris. He has also been the
Chairman of EFPIA's (European Federation of
Pharmaceutical Industries and Associations)
Manufacturing and GMP ad-hoc group.
Mr. Brading is a Chemist by background and is a
European “Qualified Person” under the permanent
provisions of EU Directive 2001/83/EC. He also
speaks fluent French. |
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S©ren
Kildebro
NNE Pharmaplan China,Project Director
Mr. S©ren
Kildebro holds Master of Science since 1985. He has
more than 14 years of experience with biotech and
pharmaceutical projects all around the world. S?ren
has worked in China since beginning of 2006.
S?ren has over the years taken roles as senior
project manager of recovery, purification, filling,
assembly and packaging projects within
pharmaceutical manufacturing and laboratories (GxP)
and is now Project Director. His experience covers
from conceptual design studies, strategies to detail
design, construction, commissioning, qualification
and handover. |
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Mr. Henry Tjong,Bayer Technology and Engineering
(Shanghai) Co. Ltd,Senior GMP Consultant
Mr. Henry Tjong is a dedicated and focused
Professional Engineer with 26 years of progressive
engineering/project/validation experience, including
more than 20 years in the biotechnology and
pharmaceutical fields.
Experience and knowledge cover as follows: Developed
knowledge of design, execution and validation of
Clean Rooms, Bio Safety Level 3 (BSL3) Facility and
Animal Facilities. Strong knowledge of procurement,
installation, commission and validation of the
utilities (HVAC, WFI, clean steam, compressed air,
medical gases etc) and production process equipment
(autoclaves, bio safety hoods, filling lines, freeze
dryers) etc. Experienced with FDA cGMP, EU GMP and
SFDA GMP regulations. Audited a few pharmaceutical
companies for cGMP and EU GMP compliances; the
companies audited include API, Oral Solid Dosage,
Sterile Injectable Powder, Sterile Injectable
Liquid, I V Bags, Machine Manufacturing and Clinical
Research Facilities located in China, Taiwan, India,
Romania and Poland.Able to conduct cGMP,
Qualification/Validation and Project Management
training in both Chinese and English. |
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Dominik
Arnold, Director Engineered Systems, PALL Life
Sciences Asia
Dominik Arnold joined PALL BioPharmaceuticals 1997
and worked in various positions in international
business development and system engineering for the
pharmaceutical industry.
In his current position Mr. Arnold is responsible
for setting up and leading system engineering teams
in Pune India, Shanghai China and currently in
Singapore. His key role is to support the Asian
pharmaceutical customers with local process
engineering and project management expertise. Mr.
Arnold also oversees PALL's business development for
engineered pharmaceutical filtration and separation
systems throughout the Eastern Hemisphere.
Dominik Arnold graduated in biotechnology from the
University of Applied Science in Zürich
(Switzerland) and has executive degrees master in
business engineering from PHW University Switzerland
and international management from NUS Singapore and
Stanford US. |
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Lida
Liu,Christ Pharma &Life Science (Shanghai) Ltd.,
Shanghai, QA/Validation Manager
07/2007—now, Christ Pharma &Life Science (Shanghai)
Ltd., Shanghai, QA/Validation Manager
1: Shinpoong Pharma., 2007.08~2007.12,
the whole project's quality control, project
documentation preparation, review and control and
FAT& SAT tester
2: Pfizer Pharmaceutical Ltd., 2007.10~2008.02,
the whole project's quality control, project
documentation preparation, review and control and
FAT tester
3: Shijiazhuang Yiling Pharmaceutical Co., Ltd.
2007.11~2008.03,
the whole project's quality control, project
documentation preparation, review and control,
review and control, FAT tester
4: Zhejiang Medicine Xinchang Pharm. Factory
2007.12~2008.04,
the whole project's quality control, project
documentation preparation, review and control and
FAT tester
5: Square Pharmaceutical Ltd-Biotech Plant
2008.03~2008.07,
the whole project's quality control, project
documentation preparation, review and control and
FAT&SAT tester
6: Eurofarma Brazil 2008.08~2008.12,
the whole project's quality control, project
documentation preparation, review and control and
FAT tester
7: Hangzhou Hisun Medicinal Plant Ltd.
2008.12~2009.04,
the whole project's quality control, project
documentation preparation, review and control and
FAT tester |
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Zheng
Xiaodong, the President and General Manager of
Shanghai Tofflon Science and Technology Co.,Ltd.
In recent years, dozens of papers on Lyophilization
technology have been published by Mr. Zheng as the
domestic well-known pharmaceutical lyophilization
expert, the visiting professor of State Food and
Drugs Administration Training Center and the expert
committee member of China Association for
Pharmaceutical Equipment as well.
In addition, Mr. Zheng was awarded the finical
support from National Natural Science Foundation of
China and Shanghai Municipal Education Commission
for his issue on ‘Primary Research of Freeze Drying
Reservation Experiment for Human Cord Blood
Nucleated Cells' and ‘Lyophilization Research of
Organic Solvent'. |
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David W.
Vincent, VTI CEO
Mr. Vincent has over twenty-five (25) years
experience in the health care industry specializing
in the Pharmaceutical, Medical Device, Biotechnology
and Biopharmaceutical industries. He has degrees in
Mechanical Engineering Technology and Industrial
Microbiology. He has over (19) nineteen years
dedicated to the field of validation. He has
expertise in many areas of Regulatory Affairs,
Quality Assurance, Validation and Engineering
including; Regulatory Submission preparation,
Engineering Design Review, Commissioning,
Construction, Quality Systems implementation,
Project Management, Utility and Process Equipment
Qualification implementation. He is especially
strong in the areas of Commissioning, Qualification,
Process Development and Process Validation as well
as developing and implementing Environmental
Monitoring and Cleaning Validation Programs. |
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Shi Lei,
ThermoFisher Scientific,Manager of Chinese Market
Department
Fisher Company
of ThermoFisher Scientific is responsible for the
affairs of market, strategy, brand and product line
management in China. Now he lives in Shanghai. Prior
to this, he worked in Market Department of American
Applied Biosystems Co., Ltd.
Shi Lei started his career by working on regional
sales for American Bio-rad in 1996, afterwards, he
joined American Applied Biosystems Co., Ltd where he
held many positions including those responsible for
sales and market. He obtained bachelor's degree in
Biochemistry in Fudan University and MBA in Shanghai
University of Finance and Economics. |
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Philippe Destremont
Technip
◎ Philippe
Destremont is a member of Expert Network in Technip
Organisation.He is a member of A3P, an Organisation
of Experts working for sterile products.
◎ Philippe is one of the Technip senior experts
since 9 years in charge of sterile drug product
facilty design and organisation. He has been
involved in many sterile projects for major
pharmaceutical companies and in various fields such
as biotech products vaccines, blood products
separation and purification.
◎ Before doing engineering, Philippe has spent 10
years as sterile products production manager in
several companies in Europe. |
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Belinda
Chen,Former GSKT leader of Quality Department
November, 2008
—General Manager of Tianjin Tasly Sants
Pharmaceutical Co., Ltd
January, 2007 — October, 2008 Quality Director of
GlaxoSmithKline(Tianjin)
She served as the leader of Quality Department
composed of about 50 employees. She led relevant
departments of the Company to successfully pass the
certification of EU MHRA Quality System.
2005 — 2006 Quality Management Manager of Singapore
Schering Plough
2002 —2005 Quality Law and Regulation & Quality
System Manager of Singapore Schering Plough
2001 — 2002 Senior Quality Director of Singapore
Schering Plough
1999 — 2001 Process chemist of Singapore Schering
Plough
1997 — 1999 R&D chemist of Singapore Schering Plough
She joined Schering Plough at the initial stage of
building factory and participated in many
construction projects (raw materials, sterile
preparations, tablets and spraying agents) in
Singapore and has working experience in research and
development, introduction of new medicines into
market, production, engineering, quality,
international auditing and validation etc, and
worked on or directed efforts in quality system (EU
EMEA, U.S FDA, other countries') certification of
the Company for many times and participated in the
construction of SAP system of the Company during
which she was sent as key talent of the Company to
America for study. She has scored achievements in
both theory and practice of enterprise management.
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Yang
Yongsheng
FDA Officer
Yongsheng Yang, Ph.D. currently
serves as a senior pharmacologist in the Division of
Product Quality Research, Center for Drug Evaluation
and Research (CDER), U.S. Food and Drug
Administration. As an acting team leader and
principal investigator, Dr. Yang plans and conducts
research to support the Center's drug evaluation
activities and to provide scientific recommendations
and expertise in the development of regulatory
guidance and policy. His duties include assessment
of safety, efficacy, stability and quality of
various drug products; establishment of in vitro
bioequivalent method to evaluate locally acting drug
product; conduction of biopharmaceutical studies;
development and validation of analytical and
bioanalytical method. Dr. Yang also provides expert
advice to the drug review divisions and other
scientific and regulatory units of the Center on the
biopharmaceutics, the chemistry, manufacturing and
controls, and other relevant sections. He has
received many awards including U.S. Department of
Health and Human Services Secretary’s Award for
Distinguished Service. Prior to joining the FDA in
2002, he was a research fellow at University of
Michigan, College of Pharmacy where he conducted
research on the gene therapy and drug delivery. He
has a patent “crosslinked DNA condensate
compositions and gene delivery methods”. Before
coming to the University of Michigan, Dr. Yang
severed as a Department Chairman and Associate
Professor at Changchun Veterinary College. He also
severed as a Vice President of Chinese Society of
Veterinary Pharmacology and Toxicology. Dr. Yang has
published about 90 original articles, review
articles, book chapters and abstracts. He has B.S.
(1982) in Veterinary Medicine, master’s degree
(1985) in Veterinary Pharmacology and Toxicology
from Changchun Veterinary College and Ph.D. (1990)
in Veterinary Pharmacology and Toxicology from South
China Agriculture University. Dr. Yang was a member
of American Association of Pharmaceutical
Scientists. |
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Jing Zhou,
Pharma Operations Manager of Foster Wheeler
Twenty years operating, consulting, management and
business development experience in Biotech/
Pharmaceutical industry with skill sets in
technology transfer, process scale-up, cGMP
operation and project management. In his current
role, he is responsible for business development &
operation management for Biotech/ Pharmaceutical
projects in the Greater China region. Through his
career, he has demonstrated his leadership in
team-building and managing cross-functional teams to
achieve long-term corporate goals through business
development, strategic planning, valuation,
negotiation and project management in various
multi-million dollar projects. He holds MBA degrees
from Columbia University and UC Berkeley. He also
has an MS degree in Biochemical Engineering from
South China University of Technology in Guangzhou,
and an MS degree in Environmental Engineering from
Wayne State University in Detroit, Michigan. |
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Mr Martin
Lush. MSc, BSc (Honours), FIBMS
Senior
Partner. David Begg Associates. UK
◎ Martin has over 30 years experience in the
pharmaceutical and healthcare industry. He has
conducted audits and education programs for many
hundreds of companies in over 25 countries
◎ A microbiologist by profession, Martin has
considerable experience in the Manufacture, Quality
Assurance and Testing of aseptic products. He is
also qualified to act as a ‘Qualified Person' within
the EU
◎ Martin is passionate about ‘Continuous Quality
Improvement' in the pharmaceutical industry. |
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Tadeusz
Jaskolski,M+W Zander,Vice President , pharmaceutical
and biotech engineering division of M+W Zander
(Shanghai)
Mr. Jaskolski
joined M+W Zander in 1990.Before joining M+W Zander,
he worked for ROM and Biprohut for 7 years.
Mr. Jaskolski has over 20 years of professional
experience in Engineering and Project Management for
Microelectronics and Phamaceutical industries. It is
worth especially mentioning that Mr.Jaskolski has
served as the project leader in CPGJ Shanghai、Mundi
pharma Beijing、Shanghai Roche Pharmaceuticals、Braun
Suzho、Fusogen Tianjin, and gotten rich experience in
local project managment. |
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Shinichi
Yamagami,JGC, Mechanical & Process Engineer in
Pharmaceutical Field
Over 20 years'
experience in fine chemicals and pharmaceutical
field as a mechanical engineer; notably in the
pharmaceutical field covering aseptic, oral dosage
and API areas.
In Aseptic Bulk Powder & Containment Project, major
activities were as follows: Finalization of material
handling flow in plant;Optimization of containment
facilities;Selection of liquid/solid separator and
drying machine;In aseptic process, design of
automatic filling line system for vial, ampoule and
syringe handling. |
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Chen Guosun,
Macroprocess Technology Co., Ltd., Quality and
Validation Director
Has over 9
years of professional experience in Pharmaceutical
Industry, especially in Validation and Quality
Management.
Be familiar with Chinese, USA and EU GMP Regulations
and Guidance.
Experience in GMP training and validation (such as
HVAC system qualification, water system
qualification, equipment qualification, cleaning
validation, process validation etc.).
Experience in Production and Quality Management in
Pharmaceutical Company. |
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Gearoid
Cronin,PM Group ASIA Commissioning and Qualification
Manager
Gearoid is PM
Group's Commissioning and Qualification Manager for
the Asia-Pacific region. Located in Singapore,
Gearoid manages our Commissioning and Qualification
business throughout Asia with a special focus on
Singapore, China and India.
Gearoid has worked all his life in the Life Science
sector in Europe, Asia and Australia, and has built
up an excellent track record in the Commissioning,
Validation and Qualification of Life Science
facilities including Biopharma, Chemical API and
Secondary manufacturing facilities.
Gearoid has experience in FDA and EMEA regulated
facilities. Most recently, he oversaw the
preparation of qualification documentation at GSK
Biological's Biopharmaceutical facility in
Singapore. |
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Feng Keting
Master degree in Automation Committee Member of ISPE
1997-2005
Senior Project Manager in Automation at NCPC (North
China Pharmaceutical Group Corporation )
From 2005 to today Pharmaceutical Branch Manager at
Automation and Drives Group of Siemens China |
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Matt
Safi,Former Invensys Eurotherm Ltd, Global Life
Sciences Business Development Director
Responsibilities include keeping up-to-date with the
latest regulatory requirement around the world and
ensuring that Eurotherm solutions match the latest
requirement of the regulatory bodies (e.g. 21 CFR
Part 11, PAT).
Matt Safi is an active member of GAMP forum. He is a
member of the GAMP's special group (Guideline for
testing systems). |
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Henry Sun,
Former FDA Officer
Ph . D of
American University of Connecticut; an expert in
pharmaceuticals research and development and
management, clinical pharmacology and biopharmacy;
former chief scientist and one of highest-level
reviewers of metric clinical pharmacology of U.S
Food and Drug Administration, member of U.S Federal
Joint Committee of Asian Executives; currently,
Vice-president of Tianjin Tasly Group, Director of
U.S SunTech Research Institute, professor, doctoral
supervisor and Faculty Director of Pharmacy
Department of Tianjin University; concurrently
specially invited scientist of U.S National
Institutes of Health (NIH), visiting professor of
Medical School of Fudan University and Nutrition
Department of Shanghai Institutes for Biological
Sciences, senior researcher of Guangzhou Life
Sciences Research Institute of Chinese Academy of
Sciences and visiting professor of Medical Economics
Research Center of Peking University etc.
Doctor Henry Sun has gathered rich experience in
forging and operating strong alliance among domestic
and foreign pharmaceutical enterprises. After
returning home from abroad, he directed the team to
complete the research, development of more than ten
kinds of domestic new Chinese patent drugs,
pharmaceutical chemicals and biopharmaceuticals and
launch them in the market, all of which have been
approved by China State Food and Drug Administration
(SFDA) in the approval document concerning new drugs
and production. Meanwhile, one Canadian approval
document concerning the launch of traditional
medicines in market, two U.S FDA approval documents
and one Australian TGA approval document for
clinical research on new medicines are obtained and
three pharmaceutical intermediates are granted U.S
DMF and European COS registration. Doctor Sun has
successfully directed efforts to launch cooperative
projects for Chinese enterprises, Indian Hetros
Pharmaceutical Group, British COOP Group, American
CureGen and Bay Capital and Hong Kong Morningside
etc. He also made joint efforts in establishing
China-Italy Joint Laboratory etc. |
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