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Global Practices in the Regulation and Enforcement of Biopharmaceutical GMP | Part 1 & Part 2
Session Chair(s)
Jianhong Yang
Researcher
Yeehong Business School of Shenyang Pharmaceutical University, China
Biotech drug is one of the fields which have enjoyed the most swift and violent development in the pharmaceutical industry in recent years. It occupies a leading position in the industry, and has clustered and enlarged constantly. For the complexity and particularity of biological macromolecules, the capacity for commercial production, quality management and risk control of biotech drugs, and the implementation of GMP management concept and system become a bottle-neck which restricts biological medicine enterprises from becoming larger and stronger. Meanwhile, with the global synchronous research & development as well as the constant updating and iteration of new biotechnologies, it has become especially urgent to establish the quality management system for the production of biological medicine according to international standards. The session will discuss the key points in global GMP regulation of biotech drugs and the practical strategies on the implementation layer from multiple perspectives, and help to promote the global synchronous research and development of biotech drugs.