Overview

NEW 2017 COURSE PROGRAMME

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.

Participants are kindly requested to read following documents before the course:
Module VIII Rev 2
Module VIII Addendum I
Scientific Guidance on PAES

What you will learn

GVP Module VIII: Post-authorisation safety studies

EMA draft scientific guidance on post-authorisation efficacy studies

Principles of pharmacoepidemiology

Study types

Methodology

Common pitfalls in protocol development

Who should attend?

Professionals who:

Work in late-stage research, peri- and post-approval drug safety, regulatory
Need to understand the post-authorisation study set up and interpret the data
Want an introduction to methodologies and/or regulatory framework related to PASS or PAES

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/effectiveness topic(s) of interest
Deal with the latest GVP Module VIII requirements for PAS studies
Understand the new regulation environment relevant to GVP PAS

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

Plan Your Team's Professional Development

The world of health care product development is rapidly evolving. To keep you at the forefront, DIA offers a broad selection of expert-led training courses in the key disciplines of Regulatory Affairs, Clinical Research and Pharmacovigilance, as well as courses created to develop other key competencies in the area of e.g. Biosimilars or HTA.

DIA can deliver this course at your organisation on dates that suit you. Our offerings can be customised to meet your exact needs. Learn how DIA can bring our outstanding training programmes directly to you and your team.
For more information please contact EMEA@diaglobal.org.

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Post-Authorisation Studies