The Global Bioequivalence Harmonisation Initiative 2nd International Conference

The Global Bioequivalence Harmonisation Initiative 2nd International Conference is scheduled for September 15-16, 2016, in the Washington DC Area, USA, organised in partnership with AAPS. Did you observe this next move in the unique initiative that is aiming for worldwide harmonsation of how to assess the bioequivalence of medicines? Scope and Aim Bioequivalence (BE) assessment is the essential...

EuPAT8: Quality by Design/Process Analytical Technology Events in Cork IE

The focus of this Conference is PAT integration into pharmaceutical manufacturing, the biopharmaceutics risk assessment roadmap (BioRAM) for the integration of preclinical, clinical and pharmaceutical development including QbD for better products and QbD considerations for emerging therapies (biosimilars and nanomedicines). Technical, practical and regulatory challenges in each of these focus...

EUFEPS QbD-PAT Sciences Network new Position Paper

The regulatory and technical landscape of the pharmaceutical field is rapidly evolving from one focused predominantly on development of small molecules, using well established manufacturing technologies towards an environment in which biologicals and complex modalities are being developed using advanced science and technology coupled with the application of modern Quality by Design (QbD)...

Position Paper on Veterinary Medicines – New EUFEPS Network Initiative

Veterinary medicines account for a substantial portion of the production, sale, and consumption of medicines in Europe, and probably world-wide. This calls our attention to the fact that only healthy farm animals can ensure safe and sufficient livestock products to meet the growing demand for animal protein. Human and veterinary medicine share many common features - expressed and symbolised by...