Oral: Other Topics

C-11 Regulatory pharmacometrics in the EU in practice and the role of the Modelling and Simulation Working Group

Kristin E. Karlsson

Medical Products Agency, Uppsala, Sweden

Objectives: To give an overview of regulatory pharmacometrics within the European Union aiming for a smoother workflow between regulators and applicants.

Overview/Description of presentation: The presentation will give a brief description of the European Medicines Agency organisation and workflow to provide an understanding of how pharmacometric analyses are evaluated. The role of the Modelling and Simulation Working Group will be explained and past and present activities of the group will be highlighted.

Furthermore the presentation will give an overview of common uses of pharmacometrics in the regulatory setting and where it plays a vital role in the development and authorization of medicinal products. The impact of pharmacometric analyses will be highlighted by examples from actual regulatory submissions. Some practical advice will be provided on how to improve communication between regulators and companies/applicants during market authorization procedures. References that can be used for good reporting standards will be included.