EUFEPS Network On Bioavailability And Biopharmaceutics

The initiation of this Network appeared to be a natural progression of the EUFEPS vision that biopharmaceutics forms the bedrock of many of the activities of the contributing societies. Its activities have provided many important opportunities to assist legislature in defining a harmonised approach across Europe. For example, proposed changes in European Guidelines in bioavailability and bioequivalence have prompted the scientific community to engage in a more comprehensive communication with regulatory scientists and to stimulate exchange between both groups. In particular, efforts focus on scientific questions, which arise from poorly resolved areas and to provide a focal point from which best practice can be developed. There is now a platform for discussion for all interested scientists. Several conferences and decision for a have been organised, and more will follow.

In 2013 the Network arranged a Open Discussion Forum on "Revised European Guideline on Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms" to responde to the draft guidlines from EMA.

In March 2015 the network organised the First International Conference of the Global Bioequivalence Harmonisation Initiative (GBHI) in Amsterdam together with international scientists and regulators worldwide including Europe, USA and Asia. The second International Conference of GBHI was realized together with AAPS in Washington in September 2016. The third meeting was held in April 2018 in Amsterdam and the fourth meeting in December 2019 in Wahsington. These well anticipated and highly successful meetings will be continued.

 

Network Leader

 

Henning Blume

SocraTec C&S Concepts and Strategies in Clinical Drug Development GmbH, Oberursel, DE