Regulatory challenges with manufacturing and clinical development of biologics

The number of biologics is steadily increasing, both in the development pipeline and on the market. Regulatory authorities' requirements regarding the development and documentation of biologics can be challenging compared to traditional drugs.

Axel Ståhlbom and Gustav Ahlin, consultants at Sofus and with extensive experience as assessors at the Swedish Medical Products Agency, will give an introduction to biologics and their equivalent to generics, biosimilars.

In addition, Axel and Gustav will discuss scientific and regulatory challenges with the manufacturing and clinical development of biologics and biosimilars.

Download the invitation (in Swedish)

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