BOSTON, March 17, 2016 /PRNewswire/ -- Health Canada, EMA, Amgen, Pfizer, AGES, MedImmune and more to meet in Boston next week to discuss the biggest challenges in the analytical and clinical phases of biosimilar drug development from responding to additional regulatory challenges, demonstrating the quality attributes needed to prove interchangeability, and successfully moving through the third phase of clinical trials.
These pressing challenges have shaped the agenda for IQPC's Biosimilars Clinical Studies & Analytical Similarity Summit, which will feature a three-pronged focus in pre-clinical/analytical studies, clinical trials and regulatory affairs. It will be held on March 21 – 23 at the Hyatt Regency Boston.
"This summit comes at a time when the industry's had a few years to work on this, but we're on the cusp of rapid change. Speakers at this summit are the people who are actually doing the work, so it's great for understanding how other companies are designing clinical trials, with an eye towards the regulatory compliance," said Vincent Capuano, Principal at Duane Morris LLP and a speaker at the summit. Vincent will be discussing the Legal & Regulatory Implications of "Similarity" and "Interchangeability."
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Dionne Vaz, Marketing Manager, IQPC