Speaker

翁新愚  国家食品药监督管理局,药品安全监管司,处长
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.
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.
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.
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.
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
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'.
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.
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.

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.

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.

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.
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.
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.

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.

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.

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.

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.

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

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).

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.