Join us for the CMC Biopharma MasterClass 3.0 on 7th and 8th November 2019 in Budapest, Hungary. This masterclass will be led by Dr. Andreu Soldevila, founder and CEO of Leanbio and Co-founder and CEO of Syna Therapeutics, companies dedicated to Biotherapeutics development, manufacture and commercialization.
This CMC Biopharma MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing, and Controls (CMC) requirements and review processes for clinical trials, registration, and post-approval 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 illustrations 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
For more information, please visit our website and request the Agenda!