Quality & Regulatory Requirements for Biosimilars in the EU

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Quality & Regulatory Requirements for Biosimilars in the EU

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Training features

Fully online

All sessions of this unique course online

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Live interaction options between the delegates and trainer

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Available via mobile, tablet or laptop

Course description

The market share of drug products manufactured by means of modern biotechnology is constantly increasing. In Germany, it is close to 25% in value.

New therapeutic options are opened for treatment of severe medical
conditions and it is obvious that this product category will become even more important in the future.

Originator companies are redirecting their main focus from APIs manufactured by chemical synthesis to APIs derived from modern biotechnological processes. As a consequence of the higher development costs, the market prizes of biotechnological drug products are high as well. This means that there will be a major cost saving potential for the healthcare systems by introduction of Biosimilar competition directly after patent expiry.

Consequently, it is vital for generic pharmaceutical companies to consider extending their business scope from drug products with chemically synthetized API to Biosimilars.

For midsize and smaller companies which do not possess the financial ressources or the know how to develop proprietary Biosimilars it is highly recommended to search for cooperations with other companies.

The training aims to create deeper understanding why biotechnological products – and as a consequence biosimilars – are a unique product category and what aspects have to be considered in R&D and Drug Regulatory Affairs.

meet the training leader
Dr. Helmut Vigenschow
Senior pharmaceutical consultant and Founder
ViPharmaService
training

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key training

Topics

Introduction to modern biotechnology & biotech products

EMA Comparability guidelines

Product-specific comparability guidelines

Marketing authorization procedures

Case studies for successful registration of biosimilars including monoclonal antibodies

GMP requirements

Benefits of attending

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