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 and co-sponsored by FDA. The detailed final programme for two full days is now posted on GBHI Conference Website at: www.aaps.org/GBHI . Scope and Aim Bioequivalence (BE) assessment is the essential basis for...

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...

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)...

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...