Member Login

              Click here if you forgot your password.

Current Events

Qualified Person Education Course Module A PLUS IMP Pre-Course Session

4-6 June 2024
Munich, Germany

EQPA Members Area

IMP Working Group Members Area

Document and track your personal development - with the Continuous Professional Development (CPD) Documentation Template

To access the template for documenting and tracking your past and ongoing activities, please go here.

After filling out the form, you will be able to create and print out a PDF file.

QPA News

<< Back to overview

08 November 2023

The position of the QP within the organization of the manufacturing authorization holder

The Qualified Person function has been defined in the EU Directives for around 50 years (since 1968 in the UK, since 1975 for EU).

The EQPA would like to understand to what extent the role and function of the Qualified Person has evolved, in response to the changes and evolution of the pharmaceutical companies that are manufac-turing authorization holders. Specifically, we would like to get a better understanding of

1) the position of the QPs within the organization of the manufacturing authorization holder
2) the position of the QPs among other fellow QPs working for the same manufacturing authorization holder
3) the differences between the organization of QPs responsible for commercial or investigational me-dicinal products
4) how the manufacturing authorization holder enables the QPs to carry out their duties and fulfil 2001/83/EC Article 46 (e)

We would therefore appreciate it if you as a QP with past and present experience completed this survey as well as forwarded the survey link up the hierarchy to the Heads of QA/Quality Unit/Heads of Quality Control and Production in your companies.

<< Back to overview