CPhI Onsite Module Conferences 2012
|Event Date/Time: Jun 26, 2012||End Date/Time: Jun 27, 2012|
|Registration Date: Jun 25, 2012|
|Early Registration Date: May 25, 2012|
From: 26 June 2012
To: 27 June 2012
Venue: Shanghai, China
Contact number: 021-61573930ï¼Œ61573919
Organizer: CPhI Conferences
One-stop platform to meet your industry peers alongside CPhI China
5 modules with extensive industry hotspots to maximize your ROI
5 Real-life case studies benchmark your technology and strategies
against the best practices in the industry
5 panel discussions after each module to get on-spot answers to your
most critical challenges
30 eminent speakers from authorities, MNCs and domestic
400 decision makers coming from home and abroad
Who Should Attend:
CSO, VPs, General Managers, Directors, and Functional Heads of: Scientific Research, R&D
Technical Operations, Manufacturing, Product Development, Regulatory Affairs, Industry Alliances, In-Licensing, Preclinical & Clinical Research, Sourcing and Procurement, Business Development, Sales & Marketing from:
Generic Pharma Manufacturers
Innovative Pharma Manufacturers
Life Science Companies
Law Firm, VC, PE
IT Solution and Consulting
5 Individually Bookable Modules:
Module 1ï¼šPharma Manufacturing in China: Regulatory Compliance and Quality Cost Balanceï¼ˆ26 June 2012 Afternoonï¼‰
Major changes in the regulatory environment have created significant time to make facility and equipment upgrades for all China pharma manufacturers. Meanwhile, the industry is facing increasing pressure to reduce costs and enhance quality to remain competitive. It is therefore more important than ever that pharmaceutical company understands new GMP compliance and implements accordingly to pass onsite investigations, meet regulatory expectations and optimize quality/cost balance.
David Chen, VP, Quality and Regulatory Affair, Shanghai Desano Chemical Pharmaceutical Co.,Ltd
Zhong Guangde, Vice President, China Pharmaceutical Association of Plant Engineering(CPAPE); Drafting Specialist; New GMP
Li Hongyang, Vice President, Site Quality, Novo Nordisk
Moudle 2ï¼šExport Strategies and International Regulatory Collaborationï¼ˆ27 June 2012 Morningï¼‰
The pharmaceutical industry has a strictly regulated environment. The regulatory framework is different in Different regulated markets like EU and US. However, thereâ€™s a harmonization trend among FDA, EU, SFDA(China) regulation for export products, which bring challenges to domestic pharmaceutical companies. Legal updates and expectations, documentations requirements, frequent findings during inspections will be discussed in this module.
Dr. Florence Benoit-Guyod , Coordinating Inspector, EDQM (European Directorate for Quality Medicines & HealthCare)
Moudle 3: Developing Biosimilar: Overcoming Market, Scientific and Legal Challengesï¼ˆ27 June 2012 Morningï¼‰
Biosimilars are steadily growing as a new field of pharmaceutical biotechnology, analytical development and clinical research in China and other emerging markets. The global market for biosimilars should grow from $243 million in 2011 to an astounding $3.7 billion in 2015, a growth rate of 1,422% over just 4 years. What then, will be the challenges be in order to be part of these opportunities? Regulatory environment, the impact of patent expiries, the profitability of biosimilars, the opportunities for antibody biosimilar, the requirements for clinical trials will be discussed in this module by giving a brief overview from MNC and leading China pharmaceutical companies.
Gurpreet Sandhu, Managing Director, REVA PHARMA
Ming Wang, PhD, Executive Director & Head of Diabetes Research, Amgen, Inc.
Module 4ï¼šAPI Sourcing in China: Latest Market Overview and Outlookï¼ˆ27 June 2012 Afternoonï¼‰
The development of new drug and generics is boosting the growth of APIs with ever-changing market demand, price and new products presence. The number of API manufacturers in India and China focused on supplying products to regulated markets has grown considerably over the past few years. This module categorizes the global and China API sourcing industry on the basis of types, geographies, trends and new API products.
Gurpreet Sandhu, Managing Director, REVA PHARMA
Rory Budihandojo, Director of Quality System and EHS (Environmental, Health, and Safety) Audit, Boehringer-Ingelheim (inviting)
Jeannie Zhang, Vice President, API R&D, Zhejiang Huahai Pharmaceutical Co., Ltd.
Module 5: Commercializing R&D: Market Oriented and Commercialization Targetedï¼ˆ27 June 2012 Afternoonï¼‰
The pharmaceutical industryâ€™s R&D process has reached a tipping point. â€œPatent cliffâ€ and economic downturn have forced current R&D model to undergo a dramatic transformation to remain competitive. This module is designed to get deep in-sight of current R&D scenario and explore new R&D mode, MNC successful casestudy to stand out from the market.
Xia Ming De, Senior Director in the Corporate Office of Science and Technology, Johnson & Johnson
Ming-Qiang Zhang, Vice President & Asia Pacific R&D Site Head, Merck Sharp & Dohme
Jun Bao, Director, Worldwide Business Development, GlaxoSmithKline
Li Youxin, Vice President of R&D, Luye Pharma Group
Fred Li, Head of Analytical Science, Roche R&D Center (China)
Jun Han, President, SOTA Pharmaceutical Inc.
More conference details, visit the conferencewebsite: www.cphichina-conference.com
Tel: +86-21-61573930, 61573919
Add: 9F, Ciros Plaza, No.388 West Nanjing Road, Shanghai 200003
For Sponsorship Opportunities, Please Contact:
Tel: +86 21 6157 3916
Mobile: +86 13671575622