Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective

• Efthymios Manolis,
• Alfredo García‐Arieta,
• Anders Lindahl,
• Evangelos Kotzagiorgis,
• Jobst Limberg,
• Øyvind Holte,
• Paulo Paixao,
• Carolien Versantvoort,
• Flora Musuamba Tshinanu,
• Kevin Blake,
• Michiel Van Den Heuvel

Affiliations

Efthymios Manolis

European Medicines Agency Amsterdam The Netherlands

Alfredo García‐Arieta

Spanish Agency of Medicines and Medical Devices Madrid Spain

Anders Lindahl

Swedish Medical Products Agency Uppsala Sweden

Evangelos Kotzagiorgis

European Medicines Agency Amsterdam The Netherlands

Jobst Limberg

Federal Institute of Drugs and Medical Devises Bonn Germany

Øyvind Holte

Norwegian Medicines Agency Oslo Norway

Paulo Paixao

INFARMED ‐ National Authority of Medicines and Health Products Lisbon Portugal

Carolien Versantvoort

Medicines Evaluation Board Utrecht The Netherlands

Flora Musuamba Tshinanu

Federal Agency for Medicines and Health Products Brussels Belgium

Kevin Blake

European Medicines Agency Amsterdam The Netherlands

Michiel Van Den Heuvel

Medicines Evaluation Board Utrecht The Netherlands