Development of generics MasterClass - EU edition

The training aims to generate a common understanding of how to best interlink two areas and create highly efficient processes from product development to routine manufacturing of generic pharmaceutical products..

07-08 November, 2023, Virtual

Time Zone : UTC/GMT+1 /CET

Overview

The interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environment and the functional priorities is a key success factor. R&D needs flexibility and should not be overregulated, whereas GMP concentrates on standardization and high throughput. On the other hand, R&D has to create a solid and robust fundament to enable manufacturing and quality control units to work according to established and efficient procedures. Product development has become even more challenging with an increasingly globalized approach of the Generics Industry which earlier was focused on national or regional markets. Today, a global perspective is business-critical to stay competitive. This global perspective has impact on the development process, starting with global sourcing of the API. Understanding the different legal environment and eventual different properties of the reference product is a key success factor for global Generic drug development. This should be considered during the entire life cycle of the drug product. The training aims to generate a common understanding of how to best interlink the R&D and GMP areas and create highly efficient processes from product development to routine manufacturing of generic pharmaceutical products. Furthermore, specific challenges related to pharmaceutical development in both regions – EU and U.S.- will be discussed.

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RECOMMENDATION

Who should attend?

• Heads of R&D

• Manufacturing Heads

• Heads of QC

• Heads of QA

• Pharmaceutical Development managers

• Manufacturing managers

• Stability control managers

• QC managers

• Drug Regulatory Affairs managers

• Product Maintenance managers