CMC Biopharma MasterClass

Date : 21st March 2019 to 22nd March 2019

Place : Austria, Wien

Website :https://glceurope.com/cmc-biopharma-masterclass-details/?utm_source=all_conference_alerts&utm_medium=media_partner&utm_campaign=CMCBPMC

Contact Person:Sara Ciesielska

Description:

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

CMC Biopharma MasterClass will be held in Wien,Austria on date 2019-03-22

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Deadline for abstracts/proposals : 8th February 2019

Keynote Speakers :

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

Venue :Savoyen, Rennweg, Vienna, Austria

Check the event website for more details.