EU Biosimilar Registration and Marketing Requirements

Feb 4, 2014 to Feb 5, 2014

Location 130 Tottenham Court Road
London, UK
Cost £1794
Details Training Course Objectives
The market for generic versions of biologics – biosimilars - has also become a huge growth area with patent expiration offering companies fresh opportunities to enter a new and highly profitable market.

With the Fda and Ema approval of the first biosimilar drug in 2007, biosimilars is now a reality. PTI's interactive 2-day training course will provide delegates with practical solutions on how to gain regulatory approval through fast, compliant registration applications.

Course Highlights:
Practical solutions and regulatory considerations to successfully achieve EU submission compliance.

Clarify the latest regulatory requirements for the registration of Biosimilars
Examine EMA guidance on immunogenicity assessment of biotechnology derived therapeutic proteins
Learn how to Prepare Module 3 of the Common Technical Document: Special issues for Biosimilars
Identify risk benefit conclusions and relevancy to clinical practice

2 day course - book after 7th January 2014 : £1495 + 20% VAT = £1794
2 day course - book before 7th January 2014 : £1395 + 20% VAT = £1674
Venue Radisson Blu Edwardian Grafton

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