Workshop on good clinical practice for bioequivalence trials/generics
Location: European Medicines Agency, London, UK
This workshop provides a platform for direct interaction between regulators and concerned stakeholders with regards to good clinical practice (GCP) aspects of bioequivalence trials included in generic marketing-authorisation applications. The workshop will bring together representatives from European Union (EU) regulators (mainly GCP inspectors and assessors), and relevant industry and contract research organisations associations. The aim of the workshop is to share best practices and to enhance understanding of the regulatory framework.