Biopharma Training Courses

An Introduction to ISO 22716 - GMP for Cosmetic Products

New for 2023

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This course has been designed to provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies/personnel considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements. The programme will cover all aspects of the ISO 22716 standard and will include practical application examples. The critical points to be considered in the cosmetic production process will be addressed and there will be plenty of time to discuss the complexities involved.

Biosimilars

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A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

New for 2023

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The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

US FDA - Understanding Key Factors When Working with the FDA

New for 2023

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This course has been designed to provide an essential overview of the key factors when working with the FDA.  It will equip senior managers and project managers with pivotal information to enable them to interact with their teams and ask critical questions to ensure the best outcomes when making applications to the FDA.