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.

What you will learn

GVP Module VIII: Post-authorisation safety studies

EMA scientific guidance on post-authorisation efficacy studies

Principles of pharmacoepidemiology

Principles of pragmatic trials

Study types

Methodology

Common pitfalls in protocol development

Who should attend?

Professionals who work in:

Clinical Safety and Pharmacovigilance
Research and Development
Medical Affairs and Medical Marketing
Regulatory Affairs
Comparative Effectiveness, Health Technology Assessment, Evidence-based Medicine

Level: Intermediate

Learning objectives

At the conclusion of this course, participants will be able to:

Understand the concept of PASS
Understand the concept of PAES
Discuss the proper study methodology and setting in relation to the safety or efficacy topic(s) of interest
Deal with the latest EMA/CHMP/PRAC and EnCePP requirements for PAS studies

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

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