Developing Biosimilars in Emerging Markets: Regulatory and Clinical Considerations This webinar will discuss the regulatory and clinical considerations for biosimilar product development in key emerging markets. It will also cover the general requirements to register a biosimilars product. Why Should You Attend: Because of the large and complex nature of biologi¬cal molecules, biosimilars cannot be guaranteed to be identical to innovator biologics. Therefore, regulators have been concerned that undetected differences in biosimilars may result in reduced efficacy or different adverse reactions. Manufacturing processes also pose challenges related to quality assurance. Over time, the U.S. FDA, EMA and WHO regula¬tory frameworks help to increase harmonization of biosimilars licensing pathways but regulation still varies widely across emerging nations. This webinar will provide an overview of biosimilars and will discuss the general requirements to register a biosimilars product. It will look at the post approval activities and the global requirements for biosimilars products. Areas Covered in the Webinar:
Introduction - biosimilars General requirements to register a biosimilar product Regulatory considerations in emerging markets Requirements for comparability data Overview of key emerging markets
Who Will Benefit:
Regulatory affairs professionals Senior management executives (CEO, COO, CFO, etc) Drug discovery and development professionals (R&D and CMC) Intellectual property experts Project Managers and Clinical trial specialists Regulatory Compliance Associates and Managers People investing in FDA-regulated product development projects
For more details please visit us at: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703475/~ Developing_Biosimilars_in_Emerging_Markets:_Regulatory_and