BIOSIMILARS CONGRESS INDIA 2016

Biosimilars Congress India 2016

The phenomenal growth of the Biosimilars industry and the recent global shift from conventional small molecule drugs to biologicals has encouraged India to look at Biosimilars as a lucrative sector. With the recent Make in India initiative and the support provided by the Indian regulators for development of biosimilars, there is a clear incentive for the major players in the pharma industry to embrace biosimilars as they are a less costly alternative to biologicals to develop yielding very high returns .

However, development of biosimilars is a lengthy process which requires heavy investment and involves a lot of challenges given the complexities of the large molecules. Also, it is very difficult to develop biosimilars with no clinically meaningful differences in terms of safety and efficacy to that of the reference product. To address these challenges, CPhI India is launching the Biosimilars Congress India 2016 scheduled from 1-2 September 2016 in Hyderabad.

Who should attend?


Research & Development – Scientist, Principal Scientist, Analytical, Biotechnology, Bioanalytical, Biosimilars, Biotech


Manufacturing


Regulatory


Production


Quality Assurance


Quality Control

Key Topics:

  • Regulatory expectations for Biosimilars in US, EU and Japan
  • Updates on the recent CDSCO Guidelines released on 26th March 2016
  • Domestic food-beverage manufacturers and suppliers
  • Identifying critical quality attributes of innovator reference products
  • Statistical analysis to determine biosimilarity
  • Assessing the Quality and CMC consideration for biosimilars

Meet The Speakers

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Key highlights of the workshop

Clarify the regulatory

Understand the FDA expectations on Biosimilars and updates on the EMA and CDSCO guidelines

Devise strategies

Explore different statistical approaches to demonstrate biosimilarity with the reference product

Video Presentation

Hear from Dr. Ajaz S. Hussain on Reducing Regulatory Uncertainty in Biosimilar Development.

Practical Case Studies

Hear practical case study insights from Indian and International experts and benefit from live examples.

Panel Discussions

Take part in timely and opportunistic group discussions around Biosimilars

Extended Q&A sessions

Facilitated answers to your most critical questions around Biosimilars

Venue & Travel

Vivanta by Taj, Hyderabad

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