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SOURCE: Xtalks
Xtalks presents a live webinar on Thursday, January 24, 2013, 11:00am EST on Biosimilar Regulatory Guidelines in India and Emerging Markets. Speaker Vijay Tammara, VP Global Regulatory Affairs, Nuron Biotech, AAPS Member, will provide a detailed description of the requirements for registration and post-marketing, as well as a Pharmacovigilance plan.
Toronto, Canada (PRWEB) January 14, 2013
For companies embarking on a Biosimilar drug development program, the goal is clear, but the road to get there is less so. If you can scientifically demonstrate that a biologic product is highly similar to the approved biologic, you will be able to abbreviate and reduce the burden of preclinical and clinical trials data package as part of submission for market authorization.
The Indian Government has developed and issued guidelines, which apply to similar biologics that contain well-characterized proteins as their active substance, derived through modern biotechnological methods such as the use of recombinant DNA technology.
A live Q&A with the audience will follow the main presentation. For more information, or to register for this event please go to http://xtks.in/xto556.
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com/ContactUs.ashx
Contact:
Karen Lim (416) 977-6555 ext 227
clientservices(at)xtalks(dot)com
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