Biosimilar from Development to Registration 2017
This event qualifies for 12 RAC Recertification
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes:
- Design and TPP
- Pre-clinical testing and comparability
- Clinical testing
- Analytical studies
- Stability of biosimilar products
Why you should attend:
The regulation of Biosimilars is very complex and the approach used by various regions differs. Professionals working in this complex area should be equipped with the latest knowledge and keep abreast of current and new legislation and requirements in this field in order to gain market access for their products.
Areas Covered in the Session:
his course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes:
- Design and TPP
- Pre-clinical testing and comparability
- Clinical testing
- Analytical studies
- Stability of biosimilar products
Who Will Benefit:
- Regulatory Affairs
- Medical Officers
- Clinical Trial Managers
Speaker and Presenter Information
Salma Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.
Relevant Government Agencies
Dept of Health & Human Services, FDA
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When
Thu-Fri, Aug 3-4, 2017, 9:00am - 6:00pm
ET
Where
Courtyard Raleigh-Durham Airport
2001 Hospitality Ct
Morrisville, NC 27560
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Website
Click here to visit event website
Organizer
GlobalCompliancePanel
