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:
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.
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