MHRA Biosimilars Masterclass

The masterclass will provide valuable insights for all professionals involved in the development of biosimilar medicinal products (process development scientists, physicians, pharmacokineticists, statisticians, immunologists, regulatory affairs staff).

The event will provide a general update of the current EU regulatory trends in the requirements for biosimilar applications. This will be followed by five specific sessions that will focus on a number of recurrent issues encountered by the regulators during the evaluation of biosimilar applications in the following domains: Quality, Pharmacokinetics, Pharmacodynamics & Efficacy, Immunogenicity and Pharmacovigilance.

Price: £390 + VAT