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CMC Biopharma MasterClass
Budapest, Hungary
07/05/2019 - 08/05/2019
URL:   Click here for the event website.
Description:
Join our CMC Biopharma MasterClass 3.0 on 07th and 08th May, 2019 in Budapest, Hungary. Training will be led by founder and CEO of Leanbio - Dr Andreu Soldevila.

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
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