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Overview

This course offers insight into EU legislation on PASS and PAES. Examples of PAS protocols as well as some examples of classic pitfalls in study conduct will be presented and discussed. There will be a chance to practice with real life examples, and participants are welcome to provide examples and questions in advance.

A PASS and PAES may be initiated, managed or financed by a Marketing Authorisation Holder (MAH) voluntarily, or pursuant to an obligation imposed by a competent authority. PASS as well as PAES can be integral parts of drug approval and continuous development. A PASS needs multi-departmental input within a company and approval at cross-organisational managerial level. It is the key to applying the right methodology for the correctly identified problem.