2016 ISPE China Biologics Development Symposium

The global biopharmaceutical industry continues to expand at rapid rate in recent years and the sales of 37 mAb drug is $42.3 billion in the first half of this year, which has created unprecedented development opportunities for the pharmaceutical and medical industries in China.  

 

There are series regulatory reforms measures have been announced since 2015: at a national level we now have far greater emphases on innovative drugs R&D; on improving submission review quality, speed and transparency; on strategies and reforms for better generic drugs quality; and on MAH systems. The support of policy and regulatory will accelerate the growth of the biopharmaceutical industry in China.


ISPE will hold a biologics symposium in Hangzhou with gathering of over 200 regulators, experts, academicians and peers from international and local pharmaceutical industry to discuss the hot topics of the biopharmaceutical industry. The 1.5-day workshop will talk about the topics on Innovation and New Technology of Biologics, Regulatory, CMC, Clinical, Process and Equipment covering the lately hottest topics. Some concurrent events are also scheduled, e.g. facility on Nov 1.


This symposium will devote 1.5 days to discuss every important element in the process of biologics development: 1, Process and Equipment; 2, CMC on Manufacturing and Innovative of Biologics; 3, Clinical and regulatory considerations and case studies sharing; 4. Frontier technology in biologics development.


Learning Objectives 
• Meet with key CFDA officers and regulators to learn the current status of MAH, clinical drug investigation, Process verification etc, in China 
• Learn from world class experts the current biologics development technologies, quality standards and practices in novel biologics development such as ADC and biospecific antibodies 
• Understand the latest China regulatory guidelines and how they relate to biologics development in China 
• Learn the current clinical development strategies and case studies for biosimilar development in China and around the world
• Learn the theory and practice of facility design and equipment in the global Biologics field
• Communicate with each other about the technology innovation progress of biologics manufacturing process in China 

 

Who Should Attend 
The decision makers at senior and middle management levels, the technical leaders and scientific staff responsible for biologics development in R&D, Regulatory Affairs, CMC, Clinical Development, Process Development, Analytical Development, Biologics Manufacturing, and QA&QC.

Chair of Program Committee
Dr. Haibin Wang

Director on the board 
Zhejiang Hisun Pharmaceutical Co., Ltd

 

International Society for Pharmaceutical Engineering- ISPE China | 2016 ISPE Biologics Symposium   
E-mail: ask@ISPE.orgchinaevent@ispe.org