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A Regulatory Perspective of Biosimilars in Emerging Markets

Speakers

Sonica Sachdeva Batra, DrMed

Sonica Sachdeva Batra, DrMed

Associate Vice President, Global Delivery Head, Indegene , India

I am an MD physician by training, with 20 years of experience in drug development and medical and scientific affairs. I am presently AVP and Global Head for Medical Affairs and Regulatory at a global technology enabled healthcare solutions provider. I have led many successful global Regulatory Authority engagements across the globe, for developed as well as the Rest of the World- emerging/ developing countries, enabling clinical development plans, strategies, marketing authorisations and post approval compliances for various products including biosimilars. I have a keen interest and experience in enhancing medical value add and scientific information dissemination for medicinal products, in the peri approval and post approval space.

Oliver  Cox, MSc

Oliver Cox, MSc

Consultant, PAREXEL International, United Kingdom

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