Pharmacokinetics Archives - European Industrial Pharmacists Group (EIPG)

The European Medicines Regulatory Network Data Standardisation Strategy


by Giuliana Miglierini The availability of interoperable data is a “must” to ensure the smooth sharing, use and re-use of data along the entire regulatory process. A new document - the European Medicines Regulatory Network Data Standardisation Strategy - has Read more

ICMRA published a Reflection paper on remote inspections


by Giuliana Miglierini Remote inspections have become a widely used approach since the last two years to ensure the oversight of the compliance of pharmaceutical productions to regulatory requirements, as the prolonged lockdown periods determined by the pandemic made very Read more

EMA’s Q&A on the integration of EudraGMDP and OMS


by Giuliana Miglierini A new step in the integration at the central level of data needed to manage regulatory procedures is going to be activated on 28 January 2022: starting from this date, member states’ national competent authorities (NCAs) shall Read more

Webinar: PBPK Modelling and Simulation – A valuable tool for Pharmaceutical Development

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Over the last 20 years Physiologically – Based Pharmacokinetic (PBPK) Modelling and Simulation has developed and is now used extensively within Discovery and Development in the Pharmaceutical Industry. Its adoption has been driven by the availability of commercial software platforms and a realisation of the benefits to be gained including the potential to reduce the number of in vivo studies performed. 

In EIPG’s and PIER’s next webinar, to be held on 21st October 2021 (17.00 CEST), Jonathan Brown will cover an introduction to PBPK modelling, what it is and how it can be applied to support Chemistry, Manufacturing and Controls (CMC) development. It will provide an overview of usage in oral, small molecule development, supported by examples from the areas of biopharmaceutics and formulation development. Current and potential future applications of PBPK modelling in Quality and Regulatory fields will also be discussed.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.