Biosimilar Product Development in China for EMEA and FDA Approvals
November 04, 2009 – November 05, 2009Zhangjiang Hi-Tech Park, Shanghai, China
Speakers: Mr. Cecil Nick, Vice President, Biotechnology and Dr. Alberto Grignolo, Corporate Vice President, Global Strategy Services
Topics to be addressed in the seminar include:
- Developing a state-of-the-art physico-chemical and biological comparability program
- The importance of bioassays and availability of bio/surrogate markers
- The value of nonclinical testing
- Designing and optimising equivalence trials
- How much clinical safety data will be required
- Extrapolating to other indications, dosage regimens and patient populations
- Immunogenicity testing
- Where to perform clinical trials
- What we can learn from European Biosimilars development
- Next generation biosimilars
- Challenges in internationalizing the biosimilar program
Please contact Charlene Cao of the Zhangjiang Hi-Tech Park, charlene.zjbpb@yahoo.com.cn to reserve a space at the seminar and / or set up a meeting.
Event Website >
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