05 July 2023
European QP Association Activities in the first half of 2023
What the European QP Association was working on in the first half of 2023 is summarized below.
Developments on the Board
Task Force on “Clinical Trial Regulation implementation experience”
The IMP QP Working Group board wishes to set-up a Task Force dedicated to the “Clinical Trial Regulation implementation experience” and has send out a mailing to the members to ask for support.
EQPA Code of Practice for QPs
The European QP Association had updated its Code of Practice for QPs (Duties and Responsibilities for Qualified Persons in the EU) – Version 9.0, which was available for free now for a short period in the open part of the EQPA website. A new Code of Conduct was added as chapter 3 entitled “Ethics for the Qualified Person – A Professional Code of Conduct”. The new code is specifically intended to define and ensure the ethical dimension for QPs. It might also be used in informing other groups (e.g. senior management) of the specific duties of the QPs. It is further intended to become a reference to QPs and NCAs.
Three months later, the Code was updated again (Version 10.0). Besides general linguistic changes and a structural review for clarity, the following amendments were made:
- new elaborated chapter on Brexit and consequences
- revision of chapter on clinical trials, adoption to Clinical trial Regulation
- update on all references to the Clinical Trial Regulation, Veterinary Medicines Regulation and ATMP Regulation/GMP Part IV
- integration of Annex 21 for importation
- integration of EQPA survey results as appropriate
Results of Survey on Annex 21 summarised and published
A total number of 110 responses were considered which allows some interesting insights and conclusions, summarised in a paper published in the EQPA Members Journal and on the Website. In this paper the collected responses are displayed and discussed.
The EQPA Board has decided to offer this year's QP Forum (12-13 October, Vienna, Austria) also as a Live Online Conference. Delegates can either attend on site in Vienna or at home/ in the office. All lectures and sessions of the main Forum will be held consecutively.
A lot of hot topics for QPs have been identified and will be discussed in the various presentations, like for example:
and many more
- Digitalisation (AI, Blockchain)
- Personalised Medicine
- Parametric Release
- Contamination Control Strategy
Preceding the Forum, three parallel Pre-Conference Sessions on specific topics will run on 11 October: Investigational Medicinal Products, Quality Culture and one for new QPs.
The December issue of the EQPA Newsletter was uploaded on the download section of the members’ area with articles on:
- The development on GMP classification of fiscal imports
- A summary of the survey results on extended QP responsibilities based on national legislation
- The ideal managed access / compassionate use legislation and on
- Quality management reviews
EMA Meeting with Interested Parties on 08 March
During the meeting of the GMDP Inspectors Working Group (IWG) meeting with Interested Parties, on 08 March 2023, future GMP were discussed like for example remote certification, Annex 11, GMP for MAHs and decentralised manufacturing.
Comments to Revision of the EU general pharmaceuticals legislation
Together with ECA, EQPA provided official feedback to the planned revision of the EU general pharmaceutical legislation.
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