The regulatory pathway to market approval

The importance of scientific advice - development of biologicals. The regulatory pathway to market approval.

Christina Jacobsson of Sofus talks about the results of the study she participated in at EMA, investigating the impact of early scientific advice on the applications submitted for new approvals.

Johanna Henriksnäs (Consultant Regulatory Affairs) and Katarina Mercer (Consultant Regulatory Affairs) from Sofus talk about the development of biological medicines from a non-clinical and clinical perspective and the importance of scientific advices. What are the regulatory challenges during development? What are the regulatory requirements and how to proceed when the guidelines are non-applicable?