08 January 2025
European QP Association Activities in the second half of 2024
What the European QP Association was working on in the second half of 2024 is summarized below.
Board Meetings and Resolutions
After ten successful years in the EQPA Board of Directors, Tor Gråberg retired and resigned from the Board. Tor joined the Board 2014 as Health Authorities representative (Swedish MPA) and after his move to AstraZeneca as industry representative. He has been a great support to EQPA, especially through his large network and his extensive knowledge of regulatory processes. The Board would like to express its sincere thanks for all his support.He will be succeeded by Ewa Rybak, Quality Assurance Head/QP at JJP Biologics, Poland. Ewa already supports EQPA as a speaker at the QP Education Course (Module B).
Further, after productive 12 years, Niina Taylor has announced that she will be stepping down from the IMP Working Group Leadership Team. Niina would like to express her thanks to the other members of the leadership team for the opportunity to be part of such a prestigious group. Rebecca Haywood from Pfizer, UK, will be taking her place on the lesadership team. From a Commercial and Clinical Analytical background, Rebecca gained her Qualified Person status while the UK was still a member of the EU. In her most recent role at Pfizer, Rebecca is releasing IMPs for use in clinical studies worldwide.
A Board Meeting was held on 29 November in Amsterdam. Agenda was:
- Open tasks from last Board Meeting
- Feedback for QP Forum 2024 and ideas for QP Forum 2025
- Feedback from experience with Engagement Board
- Discuss new possible activities
- Status of the website update
Guideline Developments
The Good Practice Guide “Code of Practice for QPs – Duties and Responsibilities for Qualified Persons in the EU” was amended with the following changes: The chapter on Brexit and consequences (chapter 4.3.4) has been revised once more. In addition, the annex has been updated with information on the national requirements in Poland. The new version 11.0 of the Guide is available in the members’ area.
Surveys
Survey of the IMP Working Group on the CTR
The new EU Clinical Trial Regulation (536/2014) (CTR) introduces a new mechanism for clinical trial approval in the EEA. CTIS, developed by the European Medicines Agency (EMA), is now the single-entry point for CTAs in the EEA. Initial submissions under the Clinical Trial Directive (2001/20/EC) (CTD) are no longer possible. With a short survey, the EQPA wanted to know how the new regulation, and related guidelines, have affected IMP QPs in the relevant aspects of clinical trials. The results of the survey were shared and discussed at the IMP Pre-conference of the Qualified Person Forum on 27 Nov 2024 in Amsterdam.
Miscellaneous
Current topic of the Engagement Board: Sharing responsibilities between QPs.
In the regular exchange between GMDP inspectors working group (IWG) with interested parties including ECA/EQPA a letter was sent to IWG in October this year seeking for advice on the risk of expired GMP certificates in 2025 if no automatic prolongation nor a replacement based on a new inspection would happen. IWG has assessed the situation and responded on 9 December 2024. Within the response two specific responsibilities related to GMP certificates have been assigned personally to the QP. EQPA expressed our disagreement to such assignment by additional response on 17 December 2024.
EQPA would like to make our members aware of IWG´s expectations which would apply from beginning of 2025 and EQPAs deviating position and sent out a mailing to the members.
Publications
Updated Job Description Template: In EQPA’s efforts to hold contents and materials provided to members up to date, EQPA’s job description template was modernized. The members of the recently created Engagement Board worked out version 2 of the EQPA job description template providing concise and easy to use guidance to the subject. It is now available to all EQPA members on the webpage.
Events
QP Forum
The 19th QP Forum was held on-site on 28/29 November 2024 in Amsterdam.
Three parallel Pre-Conference Sessions were preceding the Forum on 27 November: Investigational Medicinal Products, QP Oversight for "Virtual Companies" and MAHs and one on QP Liability and Indemnification. One of the many highlights was the Key Note and Opening Address by Emer Cooke, Executive Director of the European Medicines Agency.
About 350 delegates have joined over the three days, most of them for both, pre-conference sessions and the Forum.
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