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CMC Biopharma MasterClass

21.03.2019 - 22.03.2019

Join our CMC Biopharma MasterClass on 21st-22nd March, 2019 in Vienna, Austria!

This CMC Biopharma MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical and quality elements, implementation and documentation of the required CMC analytical and stability knowledge for biotechnology products, including biosimilar products. Practical examples will be provided as illustration and proper time will be allowed for discussion designs and outcomes.

By the end of the MasterClass, the participants will understand: 

  • Process development strategies
  • Analytical and Formulation development
  • GMP manufacture
  • Process analytical Technology
  • Guidelines and Regulatory pathways for New Biological entities and Biosimilars

Details

Start:
21.03.2019
End:
22.03.2019
Categories:
Website:
http://bit.ly/2Fru4Sh

Venue

Austria Trend Hotel Savoyen
Rennweg 16
Vienna, 1030 Austria

Organizer

GLC Europe
Phone:
+36 1 848 05 34
Email:
marketing@glceurope.com
Website:
https://glceurope.com