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PharmaNet Development Group to Host Biosimilars Symposia in Asia
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PharmaNet Development Group has announced that it will host two one-day, free-of-charge symposia to discuss clinical, scientific and regulatory issues related to the development of biosimilars. Entitled "Global Development of Biosimilars: Challenges and Opportunities", the symposia will take place on July 27, in Seoul, Korea and on July 30, in Beijing, China.
Drawing upon PharmaNet's experience, the symposia will provide insights into the global regulatory framework for biosimilars and discuss the main considerations for pre-clinical and clinical studies, assessing comparability, immunogenicity testing, and clinical pharmacokinetic/pharmacodynamic studies. In addition, a number of case studies on the US regulatory perspective on follow-on biologics will be presented. Delegates will have the opportunity to discuss any issues during two planned Q & A sessions.
Drawing upon PharmaNet's experience, the symposia will provide insights into the global regulatory framework for biosimilars and discuss the main considerations for pre-clinical and clinical studies, assessing comparability, immunogenicity testing, and clinical pharmacokinetic/pharmacodynamic studies. In addition, a number of case studies on the US regulatory perspective on follow-on biologics will be presented. Delegates will have the opportunity to discuss any issues during two planned Q & A sessions.
