22 December 2023
European QP Association Activities in the second half of 2023
What the European QP Association was working on in the second half of 2023 is summarized below.
Board Meetings and Resolutions
A Board Meeting was held on 13 October face to face in Vienna. Agenda was:
EQPA Engagement Board
- Open tasks from last Board Meeting
- Feedback for QP Forum 2023 and ideas for QP Forum 2024
- New „Engagement Board“
- New pharmaceutical legislation - sharing views
- Interaction with IWG - prioritisation and alignment of topics, follow-up actions for IWG meeting
- Update on improvements to the Discussion Forum
- Activities for the board in 2024
As decided at the Board meeting in Vienna, EQPA set up the European QP Association Engagement Board. A charter was defined to define purpose and targets. The idea was introduced in the opening presentation of QP Forum and some members showed interest in supporting such a group which were later invited to join this group.
So far, two video-conferences were held to discuss the Charta and first activities.
Survey on the position of the QP within the organization of the manufacturing authorization holder
With this survey, EQPA wanted to know to what extent the role and function of the QP has evolved, in response to the changes and evolution of the pharmaceutical companies that are manufacturing authorization holders, like the position of QPs within the organisation and among other fellow QPs, differences between QPs responsible for commercial or investigational medicinal products and how the manufacturing authorization holder enables the QPs to carry out their duties. Also Heads of QA/Quality Unit/Heads of Quality Control and Production were invited to participate.
EMA Meeting with Interested Parties
The group of Interested Parties sent a letter to EMA’s GMDP IWG with current pharmaceutical priority topics. The Interested Parties are asking GMDP IWG to bring up topics in advance where the inspectors would like to have feedback from the industry and where inspectors think the industry can improve. Furthermore, by this letter the group would like to engage in targeted discussions on specific topics.
This letter was coordinated among all associations (including ECA and EQPA) to prepare for the EMA meeting. EMA will review the proposals and assess what information will be provided at the meeting in spring 2024.
The December issue of the EQPA Newsletter was uploaded on the download section of the members’ area with articles on Quality Oversight and Pharmaceutical Contracts.
The 18th QP Forum was held as a hybrid conference on 12/13 October. Delegates could choose whether to join live on-site in Vienna or live online on a screen.
Three parallel Pre-Conference Sessions were preceding the Forum on 11 October: Investigational Medicinal Products, Quality Culture and one dedicated session for new QPs.
The hybrid version of the Forum was very successful. About 275 delegates have joined over the three days, most of them on-site in Vienna.
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