GMP Compliance: how critical to your success of biological product to the market

8^th Asian Biologics and Biosimilars Congress

August 10-12, 2017 Beijing, China

Frank Cheng

Alban Phamra(Hong Kong) Co., Ltd, China

Scientific Tracks Abstracts: J Bioanal Biomed

Abstract :

GMP represents a quality management system manufacturing and submission of biological products. For filing IND in biological products for clinical studies, GMP compliance is required at the different levels. The topic shall address GMP conditions and GMP compliances from Phase-I, Phase-2, Phase-3 clinical studies through commercialization with MA.

Biography :

Frank Cheng is the Founder and Principle Senior Consultant of Alban Pharma, Hong Kong, which is a leading consulting company on biosimilar development and submission to EU and US. With his PhD from Canada and PDF experiences from JHU in USA, he is now directing and managing several biosimilar projects from GMP compliance to design and implementation of regulatory submission roadmaps.

Email: yuducheng@hotmail.com