webinar

Developing high quality biosimilar products for western markets

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July 27, 2016

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Summary 

This seminar is designed primarily for Asian companies targeting biosimilar product registration in the West (e.g., U.S., EU and Canada).

The webinar will address 3 key areas:

1) FDA/EMA regulatory expectations for biosimilars, including:

  • Stepwise development program
  • Basic requirements for analytical, nonclinical and clinical considerations
  • Similarities and differences between FDA/EMA requirements

2) Reference products, including selection criteria and evaluation of critical quality attributes.

3) Common errors in the development of biosimilar products, with tips on how to avoid wasting time and money – and the potential derailment of your biosimilar development program.

Register to learn from Quintiles experts on how to improve your probability of regulatory success.

Speakers

Ling Zhen, JD, MBA, Senior Vice President and GM, Greater China or Designate

Kamali Chance, MPH, PhD, RAC, Vice President, Head, Global Biosimilars Regulatory Strategy, Quintiles

Oxana Iliach, PhD, Senior Director, Global Regulatory Strategy and Biosimilars CMC, Quintiles

Kristof Vandekerckhove, Senior Scientific Advisor, Quintiles