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.
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.