EQPA News
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.
In our 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. We as EQPA expressed our disagreement to such assignment by an 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 EQPA’s deviating position.
For more detailed information please see
EQPA's letter from 9 January 2025 expressing our deviating opinion.
What the European QP Association was working on in the first half of 2024 is summarized below.
Board Meetings and Resolutions
EQPA Engagement Board
During the QP Forum 2023 a new initiative to establish a new platform to selected EQPA members was made public. Volunteers who want to engage on a regular basis in the new EQPA Engagement Board were looked for. The group was successfully kicked-off and met three times since December 2023 – TCs are foreseen every 6 weeks. A first target is to learn to know each other, build trust and experience how to best work together in this setup which is new for all involved. First project was to create a job description.
Surveys
Survey on EMA Q&A on remote certification / confirmation
In July 2023 EMA published three Q&As to clarify expectations on remote certification by QPs across Europe. The Q&As were provided in response to discussions held during the yearly joint meeting in early 2023 between the EU GMP and GDP inspectors working group (IWG) and interested parties including ECA/EQPA. In preparation for the 2024 joint IWG –Interested Parties meeting the IWG requested feedback as to whether the Q&As had been useful to QPs. EQPA set-up a membership survey to collect feedback on the usefulness of these Q&As. The results of this survey were discussed with IWG on March 7th, 2024 during the joint IWG-Interested Parties meeting.
A total number of 120 responses with 103 coming from EU member states were considered in this survey allowing some interesting insights and conclusions. The non-EU responses were in some cases used as reference sample.
Survey on Chinese Counterespionage Law
China has revised its counter-espionage law. Compared to the previous version, the new version expands the government's powers to combat espionage and emphasises the role of the public in this task. In theory, activities carried out as part of an audit or inspection can now also be punishable by law. Espionage suspects may be prevented from leaving China by order of the national security authorities at provincial level or higher. This provision also applies to foreigners.
For that reason the EQPA as well as the GMP Auditor Association asked for feedback with regard to their members’ awareness, understanding and implication of the Chinese revised counterespionage law. Results can be found in the survey section of the members’ area.
Survey on the use of QPSHARE
A short survey was created to get valuable insights into its usage, awareness, and areas for improvement. Responses have been collected from 170 survey participants. Only 22 (13%) were aware of the QPSHARE database before receiving the survey. Overall, it can be said that the database and, in particular, the possibility of carrying out joint activities such as joint audits or sharing audit reports is not used very often. This may be mainly due to a lack of knowledge of the database. The EQPA can only encourage its members to utilise the database and the opportunities it offers to save resources.
Survey results on the QP’s position within the MIAH organization
The survey results summary report on the QP’s position within the MIAH organization have been published in the “Members’ Surveys” section.
Please check the Members' Survey Results section in the members' area to read detailed reports on the survey results.
Miscellaneous
EMA Meeting with Interested Parties on 07 March
During the meeting of the GMDP Inspectors Working Group (IWG) meeting with Interested Parties, on 07 March 2024. EMA provided an update on the activities of the IWG in 2023, with focus on the regulatory flexibilities in light of the COVID-19 pandemic, the progress on IWG Drafting groups on guidelines and Q&As, developments concerning Mutual Recognition Agreements as well the outlook for 2024 with areas of focus for the GMDP IWG.
ECA/EQPA provided feedback on the general process of revision of the GMP guidelines, and proposed areas for consideration for improvement of this process to maintain the consistency and integrity of the overall guidelines. The GMP IWG recognised the need to maintain the consistency and integrity of the GMP guidelines, and ensured that when a guideline is being drafter or revised, consideration on impact to other sections is given.
EQPA provided detailed feedback on the results of a EQPA survey on the published Q&A on remote certification. The overall feedback was that the guidance is considered useful, and more QPs are considering remote certification following the clarifications. The survey also identified that a more standardised approach between the MSs is still an area for improvement.
The IWG acknowledged the survey results and supported the interested parties to continue monitoring the implementation and report any further updates.
Following the meeting, the Interested Parties sent a letter to provide feedback to the attention of the GMDP IWG. IPs greatly appreciate the interaction and feedback during that meeting and want to build on that experience and point out opportunities for improvement, especially with respect to the communication in both directions by discussing details on topics of mutual interest.
Meetingwith EDQM
EDQM wants to foster regular exchange with industry associations and has contacted EQPA. A first meeting was held on 11 March 2024 for a further introduction and sharing ideas. EDQM will organise a meeting in the second half of this year to discuss current issues and collaborative measures for 2025. In general, measures would be supported by both sides to raise awareness about the European Pharmacopoeia and other activities of the EDQM.
Publications
EQPA Newsletter
A new issue of the EQPA Newsletter was published including articles on the results of the surveys on the position of the QP in the MIAH organization, Remote Certification and QPShare.
Events
QP Forum
The EQPA Board has decided to offer this year's QP Forum (28/29 November 2024, Amsterdam) as on-site only Conference. A lot of hot topics for QPs have been identified and will be discussed in the various presentations. After a Key Note by the Executive Director of the European Medicines Agency, Emer Cooke, a lot of hot topics for QPs will be discussed in the various presentations and interactive sessions.
Preceding the Forum, three parallel Pre-Conference Sessions on specific topics will run on 27 November: Investigational Medicinal Products, Quality Oversight for MAHs and one on Liability.
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:
- 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
EQPA Engagement Board
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.
Surveys
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.
Miscellaneous
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.
Publications
EQPA Newsletter
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.
Events
QP Forum
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.
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.
Please see the results report in the members' areas survey section.
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.
Guideline Developments
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
Surveys
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.
Events
QP Forum
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:
- Digitalisation (AI, Blockchain)
- Import/Export
- Oversight
- Personalised Medicine
- Parametric Release
- Contamination Control Strategy
and many more
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.
Publications
EQPA Newsletter
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
Miscellaneous
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.
The EU Directives and the EU Guide to GMP define some detailed requirements to be met by the Qualified Person (QP). These requirements have been extracted from the relevant documents and are summarized in the Good Practice Guide "Code of Practice for QPs". However, a number of responsibilities as well as requirements for continuous training for QPs are not defined in detail. This Good Practice Guide - considered a "living document" - gives recommendations to QPs.
Version 10.0 has now been published. 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
The Good Practice Guide including a chapter on the “Ethics for the Qualified Person – A Professional Code of Conduct” and the Annex on National QP Implementation is accessible exclusively for members of the European QP Association. To find out more about the Guide, please see the more detailed information and a video.
If you are member please use the login at the top to get to the Good Practice Guide. If you would like to apply for membership, please see the membership application forms.
What the European QP Association was working on in the second half of 2022 is summarized below.
Board meetings and resolutions
A Board Meeting was held on 02 December face to face in Berlin. Agenda was:
- Open tasks from last Board Meeting incl. update to the QP Code of Practice/ EQPA Code of Conduct
- Feedback for QP Forum 2022 and ideas for QP Forum 2023
- Update IMP Working Group
- IWG interaction 2022 and outlook 2023 - alignment on general positions
- possible political and other threats and their influence on application of GMP and whether this will need attention also by EQPA
- Projects: Chapter 4 and Annex 11 update
Developments on the Board
Brenda Van Assche was winding down her responsibilities in the IMP Working Group after seven very successful years of excellent work. The Committee’s has taken the decision to appoint Katrien Himpens as Brenda’s successor with the aim of maintaining the same spread of pharmaceutical company size. Katrien is Director Quality Assurance and Qualified Person at Janssen, Pharmaceutical Companies of Johnson and Johnson.
Cheryl Chia was invited to join the EQPA Board of Directors. Cheryl is an independent consultant since 2019, providing advice and acting as QP if necessary to pharmaceutical companies that are developing their organisations in Europe. Cheryl was originally a hospital pharmacist in England and made the switch to Industrial Pharmacist when she moved to the Netherlands in 2002. There she worked for 7 years at Organon N.V. in various roles and for 10 years at Amgen Europe B.V. in various roles including Production QA, QP and RP and Supply Chain.
Gudeline Developments
White Paper on Annex 21 and fiscal importation
EQPA has published a paper in the download section of the members’ area discussing “Developments on GMP classification of fiscal imports”. Background: The potential need for an Annex 21, finally published in February 2022, was identified during the development of Annex 16 – when the authors concluded that not all topics around importation could be clarified. One dominant and main driver for the new Annex 21 is thus the existence of fiscal importation and whether such concepts of international money transactions crossing outside boarders of the EU should be handled according to GMP regulations or not. The issue was legally complex. Annex 16 was cleared to be published in 2016, the solution on fiscal importation was expected to come with Annex 21. It did not.
David Cockburn, Georg Goestl, Ulrich Kissel have a finalised a document on Professional Code of Conduct (Ethics for the Qualified Person) which will become part of the current EQPA Code of Practice for QPs as a new Chapter one. Publication will be done via mailings and video on EQPA website, Linked-In and magazines.
Surveys
National requirements for QPs beyond EU requirements
EU law is built on parent acts including directive 2001/83/EC and since end of January 2022 the Regulations 536/2014 on Clinical Trials (CTR) and Regulation 2019/6 on Veterinary Medicines (VMR). EudraLex Volume 4 includes a common interpretation of how to comply with EU legislative expectations. The specific responsibilities of the QP are not really numerous as defined in directive 2001/83/EC. However, EQPA knows from discussions and previous surveys that countries may add specific additional requirements and personal responsibilities for QPs beyond this directive and the GMP Guides.
With this survey sent out end of July with a reminder end of August, EQPA was looking for more insight in this. Results should also support argumentation for a better harmonization across the Member States.
Annex 21
After a rather long development phase, Annex 21 Importation of medicinal products was published in February 2022. It defines the different roles of manufacturers and QPs working with such manufacturers involved in importation. Its transition period ended by 25 August 2022. With this survey sent out late November, EQPA wanted to learn more about the impact of this new guideline on QPs – e.g. which compliance gaps may have been identified and how successful they have been closed. The survey particularly addresses responsibilities of QPs involved in importation scenarios.
Events
QP Forum
The 17th QP Forum was held as a hybrid conference on 01/02 December. Delegates could choose whether to join live on-site in Berlin or live online on a screen. Two parallel Pre-Conference Sessions were preceding the Forum on 30 November: Investigational Medicinal Products and Quality Culture The hybrid version of the Forum was very successful. About 350 delegates have joined over the three days (approx. 2/3 on-site and 1/3 online)
Miscellaneous
EQPA is working with other stakeholders on an industry follow-up on COVID-19 & supply chain activities: As a follow-up of the EMA-IWG-Industry meeting, industry would like to provide to the IWG the feedback on the EMA-IWG action item: ‘The Interested Parties are invited to provide suggestions for consideration by IWG on potential alternative measured to manage expiring GMP-certificates at the end of 2022’.
A paper for the EMA GMP/GDP IWG on Qualified Persons (art. 48 of Directive 2001/83/EC) Practical Experience Requirements was prepared by EQPA/ECA (lead) and EFPIA. During the GMP/GDP IWG meeting with Interested Parties in March 2022, the lack of harmonisation in the interpretation and transposition of the practical experience requirements for Qualified Persons (QPs) laid down in EU legislation was presented. A proposal was therefore made to harmonise approaches, for example through guidelines. The Commission’s representative at the meeting invited the Interested Parties to submit a proposal directly to the Commission in the context of the ongoing revision of the EU general pharmaceuticals legislation. EQPA, together with ECA Foundation (ECA) and EFPIA wrote a problem statement with a detailed proposal and rational.
Suggestion to amend Directive 2001/83/EC on Requirements for the Qualified Persons
During the meeting of the GMDP Inspectors Working Group (IWG) meeting with Interested Parties the lack of harmonisation in the interpretation and transposition of the practical experience requirements for Qualified Persons (QPs) laid down in EU legislation was discussed. A proposal was therefore made to harmonise approaches, for example through guidelines. Grasping that the underlying cause of the problem is because of the terminology used in the EU legislation (Dir 2001/83/EC), the Commission’s representative at the meeting invited the Interested Parties to submit a proposal directly to the European Commission in the context of the ongoing revision of the EU general pharmaceuticals legislation.
The European Qualified Persons Association (EQPA), together with ECA Foundation (ECA) proposed to amend Directive 2001/83/EC on Requirements for the Qualified Persons.
EU Commission DG SANTE Unit B4 will now make will make a proposal for the revision of article 49 taking into account the suggested changes!
The European QP Association (EQPA), representing more than 4.200 Qualified Persons (QPs) and professionals in similar functions from across Europe and beyond, has announced changes in its Advisory Board.
Cheryl Chia was invited to join the EQPA Board of Directors, extending the board’s industry side from five to six members. Cheryl has been an independent consultant since 2019, providing advice and acting as QP if necessary to pharmaceutical companies that are developing their organisations in Europe. Cheryl was originally a hospital pharmacist in England and made the switch to Industrial Pharmacist when she moved to the Netherlands in 2002. There she worked for seven years at Organon N.V. in various roles and for ten years at Amgen Europe B.V. in various roles including Production QA, QP and RP and Supply Chain.
Further, the EQPA’s IMP Working Group, representing more than 2.100 Qualified Persons (QPs) and professionals in the Investigational Medicinal Products (IMP) area also announced a change in its group leadership.
After seven very successful years of excellent work, Brenda Van Assche is now winding down her responsibilities in the group. The group has appointed Katrien Himpens as Brenda’s successor with the aim of maintaining the same spread of pharmaceutical company size. Katrien is Director Quality Assurance and Qualified Person JSC at Janssen, Pharmaceutical Companies of Johnson and Johnson. “I would like to extend my heartfelt thanks to Brenda for her outstanding service to the board and her energizing and inspiring contribution to the success of the organization” Dr Susanne Ding expressed her thanks for the long-time leadership colleague. “At the same time, we very much look forward to working with Katrien. With her experience she will definitely be a very valuable addition to our team.”
It is with deep sadness that we must advise that our friend and colleague, Richard (Dick) Bonner passed away on Monday 7th February 2022.
Dick was, until he resigned in 2017, Chairman of both the ECA Foundation and the European QP Association and remained closely connected with both organisations until his untimely death. He was always happy to offer advice and support. His extensive knowledge of the pharmaceutical industry was gained over the course of 31 years working in production, technical services and in both Quality Control and Quality Assurance functions. He was a Qualified Person and was formerly a Senior Quality Advisor for Eli Lilly and Company, before establishing himself as a well-respected independent quality consultant.
Already a very popular speaker at many conferences and training courses organised by the ECA Academy, Dick joined the ECA Advisory Board in 2002 and, in 2007, was nominated as the organisation’s Director of Regulatory Affairs. Dick was well-known in the field, so he assured appropriate recognition for ECA and successfully raised its profile. In 2010 he was appointed Vice Chairman and in 2011 he succeeded Daniel Scheidegger as Chairman of the ECA Advisory Board, which later became the ECA Foundation.
Throughout his leadership, Dick continued to advance the ECA making it one of the leading stakeholder organisations in the field of pharmaceutical quality assurance and GMP/GDP, in Europe and beyond. During his tenure, five new special interest groups were established providing colleagues in the industry with valuable information and services. His vision, in restructuring the organisation, has allowed the ECA Foundation to involve colleagues from other industry groups on a case-by-case basis and has also allowed representatives from European authorities to get involved in certain ECA activities, whilst ensuring that the latter retains its independence and avoids any potential conflict of interest.
At the end of 2012, Dick also became Chairman of ECA’s European QP Association (EQPA); representing Qualified Persons in the European Union. Here also, he was the major driver in the development of activities and establishing the EQPA as a well-respected organisation throughout the pharmaceutical industry.
Dick’s energy and vision shaped ECA and we will always remember his enthusiasm and the willingness with which he shared his extensive knowledge. With his passing, the ECA and the EQPA have lost not only an extraordinary personality and great leader, but also a very good friend.
What the European QP Association was working on in the second half of 20221 is summarized below.
Board meetings and resolutions
A Board Meeting was held on 06 December. Agenda was:
- Feedback QP Forum 2021
- Review of meeting minutes board meeting 2020
- IMP Working Group Update
- Current and Possible future projects
- Planning the QP Forum 2022
Guideline developments
EQPA Code of Practice for QPs
After a major revision in 2020, Annex 1 of the document was now completely revised based on a survey and feedback from members. Annex 1 summarises the EU member states’ national requirements for becoming a Qualified Person and other national specifics.
Please see the new version 8.0 of the complete Code of Practice for QPs from November 2021.
Surveys
The assessment of the Survey “QP qualification requirements in different member states” was written by Ulrich Kissel and reviewed by David Cockburn.
The survey focused on the professional route to becoming a QP and related topics. EQPA is grateful again for its members’ strong engagement resulting in a wealth of data, which was analyzed in the respective assessment. As usual in such surveys the outcome can only reflect the variety of responses received. Responses from different participants may differ only slightly or sometimes, even conflict. Given the responses result from individual experiences, the authors had no desire to filter them in any way. The assessment is available on the website and in EQPA membership Letter.
Survey on QP Integration in Organizational Structure
Chapter 2 of the EU GMP Guide defines key personnel to be available at a pharmaceutical manufacturing company and respective responsibilities while at the same time providing some flexibility regarding the personnel taking responsibility. Depending on the organizational structure, it has to be carefully defined who takes what responsibility. With this survey EQPA would like to get an overview on how today’s organizations operate. With the results also intends to contribute to a better clarification in the current GMP Guide with a better basis for influencing and commenting on potential upcoming revisions.
Benchmark IMP Batch Certification/Regulatory Compliance Check
Depending on individual organisations and processes established, the batch certification may happen at different points in time. With a short survey as a benchmark, the IMP Working Group wanted to gain an overview of the current practices and possible changes coming along with the upcoming Clinical Trial Regulation.
Reflection Paper GMP and MAH
On 23rd July 2021 the Reflection paper on Good Manufacturing Practice and Marketing Authorization Holder was published by EMA in its final version. QPs need to have a good understanding of the contents of this new reflection paper and may need to work on identifying and closing gaps in interactions with the MAH not previously given adequate attention. These considerations provided the basis for a survey covering the main topics of the Reflection Paper.
Summaries of the survey results are available in the section Members Surveys. For detailed articles on the survey results, please see the EQPA Members Newsletter in the Dowload Area.
Events
QP Forum: This year's QP Forum on 02/03 December was again only available as a Live Online Conference. As all lectures in the main Forum and the Pre-Conference Sessions were held consecutively delegates could follow them at their screen.
In July 2021 the WHO issued the revised versions of their working documents
- "WHO good practices for research and development facilities of pharmaceutical products"
- "Good manufacturing practices for investigational products"
for public consultation until 31 August 2021. For more detailed information on the new WHO documents please also see the news on the new WHO Draft on GMP for IMPs and the new WHO Draft on GxP for Development.
We plan on providing the WHO with comprehensive comments for these revisions and therefore would like to invite you to also use the following commenting template and return your comments by 15 August to IMPQP@qp-association.eu:
Commenting Template for WHO working document "good practices for research and development facilities of pharmaceutical products"
- Commenting Template for WHO working document "good manufacturing practices for investigational products"
The group will consolidate all comments received and submit one file to the WHO. The consolidated comments will also be posted in the IMP Group's members' area.
We flagged this update already during last year’s QP Forum. To continue the dialog, it is already noted for the agenda of this year’s IMP Pre-conference in Berlin on 01 Dec 2021.
What the European QP Association was working on in the first half of 20221 is summarized below.
IWG/Interested parties meeting with EMA
EQPA was invited by EMA’s GMDP IWG for a teleconference with other stakeholders on Friday 22nd January. For preparation of the meeting, EFPIA invited for a coordination call to discuss. Main topics were the EMA GMP/GDP -IWG Working plan 2021, covering progress on new/updated guidelines and inspection and audit management in a changing environment.
IMP Working Group
The IMP Working Group has commented WHO’s Working Documents QAS/20.863 “Good manufacturing practices for investigational products” and QAS/20.865. Documents were submitted to WHO.
IMP Working Group has prepared and published a regulatory requirement summary on Compassionate Use/ Managed Access for QPs. The Summary contains the requirements on 40 different Compassionate Use/ Managed Access types from 28 countries of the EU/ EEA and the UK.
Surveys
After one year under the measures to cope with the COVID-19 pandemic EQPA asked for an update on the overview of different national requirements/ expectations from the QP regarding presence on site and remote certification. A survey on this was already sent out about one year ago. But a lot has happened since the early days of the pandemic and procedures and approaches have been adjusted by Health Authority communications as well as internally in organizations and work places. With this survey EQPA wanted to learn more about changes to these expectations in the view of inspectors as well as the members’ view and perception. Results have been summerised and were published on the website and in the EQPA Membership Letter.
Survey on Directive 2001/83/EC articles 48 till 52: Directive 2001/83/EC forms and defines the legal framework of the role of the QP in the five articles 48 till 52. Discussions often focus on article 49 defining the minimum requirements to become a QP. Less attention is often given to the provisions set by article 52. EQPA wanted to get an overview of the different national solutions and approaches for article 52 compliance, QPs’ experiences and assessment. The survey therefore specifically focused on the way and mechanisms how article 52 and the code of conduct or equivalent are being implemented and enforced in the member states.
QP Forum
The decision was made to offer this year's QP Forum also as a Live Online Conference. All lectures and sessions of the main Forum will be held consecutively and can be attended by all participants - either directly on site in Berlin or live online. A first programme with three pre-conference sessions was finalised and published.
Miscellaneous
The two discussion forums on the EQPA website (IMP and the regular one) were combined. The IMP discussion forum remains as a “read only” forum on the website for a while. With this, members can still have a look at older entries.
David Cockburn and Ulrich Kissel worked on an article on Remote Certification to be published Euromed’s magazine Industrial Pharmacy.
Job Description: Under the leadership of Georg Göstl, EQPA developed and published a Job Description Template for QPs.
David Cockburn has written an article for Euromed Publications GMP Review: Good Manufacturing Practice and the Marketing Authorisation Holder (When does a marketing authorisation holder have to comply with GMP?) The article will also be published in the EQPA Membership Letter.
What the European QP Association was working on in the fourth quarter of 2020 is summarized below.
Preparation of IWG/Interested parties meeting with EMA
Ulrich Kissel attended several telecons on proposals for topics to be discussed by the interested parties with EMA-IWG during a proposed next EMA-IWWG interested parties meeting anytime during the next winter season. During the first teleconference (TC) on 05 October, all interested parties shared their list of proposed topics. During the TC priority topics were defined.
The process itself starts with drafting and finalisation of a letter addressing the need for clarification or action. Interested parties volunteer to draft the respective paragraphs of this letter on identified topics coordinating with e-mail input of the other defined interested parties. In three topics ECA-EQPA is supposed to take lead in preparing and aligning with other associations the associated problem statements expressed to EMA-IWG.
The letter itself has caused some discussions between the interested parties . However most concerns from EQPA have been considered. Still ECA/EQPA would probably set priorities differently and write a shorter cover letter.
The EQPA has now been invited by EMA’s GMDP IWG for a teleconference with other stakeholders on Friday 22nd January. Main topics to be discussed:
- The EMA GMP/GDP -IWG Working plan 2021; covering progress on new/updated guidelines
- Inspection and Audit Management in a changing environment
- Further topics of concern
For preparation of the meeting, EFPIA invited for a coordination call to discuss the next steps for Monday, 11th January 2021.
The EQPA was also invited by EMA to join a webinar on the “UK withdrawal from the European Union – End of Transition period” end of November. EQPA’s questions have been taken up at the end and prioritized against others, However many other questions were left unanswered.
QP Forum: This year's QP Forum on 26/27 November was only available as a Live Online Conference. As all lectures in the main Forum and the Pre-Conference Sessions were held consecutively delegates could follow them at their screen.
Two parallel Pre-Conference Sessions were preceding the Forum on 24 & 25 November: Serialisation (24 November) and Investigational Medicinal Products (25 November).
The online version of the Forum was very successful. Overall 230 delegates have joined over the four days.
EQPA Code of Practice for QPs
This Guide has now undergone a major revision and has just been published with the new title “Code of Practice for QPs – Duties and Responsibilities for Qualified Persons in the EU” – including an update of Annex 1 with the EU member states’ national requirements for becoming a Qualified Person and with other national specifics. “Code of Practice for QPs”.
Comments from the IMP Group to new WHO Documents
WHO issued new working documents on IMPs and research and development facilities for public consultation. The IMP working group plans on providing the WHO with comprehensive comments for these new documents and therefore invited working group members to give comments.
In December 2020 the WHO issued two working documents for public consultation:
- Good Manufacturing Practices for Investigational Products and
">Good Practices for Research and Development Facilities.
These two documents are open for commenting until 6 January 2021.
The IMP Group wants to provide the WHO with two consolidated documents from IMP QPs and therefore invites interested QPs to take advantage of the following commmenting templates and to return them by 15 December to IMPQP@qp-association.eu:
- Commenting Template for WHO working document "Good Manufacturing Practices for Investigational Products"
- Commenting Template for WHO working document "Good Practices for Research and Development Facilities"
The group will consolidate all comments received and submit two files to the WHO. The consolidated comments will also be posted in the IMP Group's members' area.
What the European QP Association was working on in the third quarter of 2020 is summarized below.
Guideline Development
To revise the European QP Association’s Good Practice Guide Ulrich Kissel sent out an updated and revised draft for comments. The final version is planned to be available for publication in November.
Surveys
The results of the survey on Remote QP Certification were published in the members’ area of the EQPA Website and in the EQPA Membership Letter.
The IMP-Working Group of the European QP Association has set up a survey on “Compassionate Use / Managed Access Release Requirements” to help getting an overview of the various regulatory requirements and concepts.
Background: Non-approved medicines can be made available to patients suffering from life-threatening or serious medical conditions where no satisfactory treatment option exists.
Numerous concepts exist that can apply to individual patients or groups of patients. These concepts relate to products that are typically in Clinical Development and/or a Market Authorization Application is ongoing. Such concepts are named e.g. compassionate use, named patient use, expanded access, managed access, pre-approval access, post-trial access, and others.
Other Activities
EQPA has sent the team´s consolidated final version of comments to the Annex 21 draft to the EU Commission. The team was working hard and collected numerous significant comments. EQPA highly recommends a 2nd draft, the current one has significant shortcomings, which to EQPA’s assessment can not be closed in one next step.
IWG/Interested parties meeting with EMA: EFPIA is taking the lead to co-ordinate the IWG/Interested parties meeting with EMA. ECA/EQPA are invited to prepare a letter to trigger discussion with EMA-IWG. It is expected that EMA-IWG will make themselves available in a teleconference as in last years. This would be the third year in a row, where no face to face meeting at EMA will be organised. Due to limited resources at EMA telecons were organised during the first months of the new year and not in November as before.
The EQPA Newsletter is now available in the download section of the members’ area.
The European QP Association is quite active in supporting its members. What has been achieved in 2020 so far?
Guideline interpretation
David Cockburn commented EMA’s Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders (EMA/457570/2019), proposing a complete overhaul of the Paper to make it much shorter and better aligned to the respective responsibilities of MAH and MIAH. Comments were officially sent to EMA as an EQPA feedback.
Annex 21 was published. An EQPA expert panel was set up to officially comment the draft. After three video-conferences, a final document with comments was created. The document also takes into account feedback from the EQPA members. The final version will be sent to Concept for handing in to EC.
EQPA is part of the ECA expert group commenting Annex 1.
Surveys
The EQPA is very active in getting feedback from its members. Several survey were conducted:
Remote Certification (sent out 02 April): Due to the current Sars-CoV-2 outbreak, more and more people have started working from home; this includes Qualified Persons (QPs). The EU Directives and Annex 16 do not specify how much time a QP should spend at the manufacturing site; neither do they discuss remote batch certification by QPs. The interpretation of the requirements by national inspectorates and their respective expectations are not harmonized across the European Union/EEA/UK. With this survey, EQPA, wanted to get an overview of different national requirements/expectations from the QP regarding presence on site and remote certification. More than 300 QPs responded. The results were discussed – amongst other topics – discussed in a Webinar on 28 April. A summary will be written by Ulrich to be published in the EQP Membership Letter.
Annex 21: On March 20th EC/EMA published Annex 21 for public consultation by interested parties. EQPA has reviewed and drafted comments to this document, but would like to get a broader input from the members, ensuring that the final feedback also reflects their views and needs in relation to this document. Survey was sent out on 05 May.
Professional QP Development (23 June 2020): EQPA has set up a questionnaire to find out about how aware QPs are of their needs and whether they feel adequately positioned and supported to develop the needed skills on the one side – and the awareness of this need by the employers on the other.
Meetings
Ulrich Kissel and Afshin Hosseiny (ECA) have joined the EMA teleconference on 23 January to update industry stakeholder organisations on IWG activities. Ulrich was the spokesperson for the agenda topic “General QP-responsibilities”. Meeting notes were prepared by EfPIA.
Events
Due to the Corona crises, the QP Education Course incl. IMP pre-course session will be held on 15/16/17 September 2020 as Live Online Training.
The decision was made to offer this year's also as a Live Online Conference. All lectures and sessions of the main Forum will be held consecutively and can be attended by all participants - either directly on site in Berlin or live online.
Good Practice Guide
EQPA has started revising the Good Practice Guide. Many chapters will be updated and amended and chapters on the following topics will be added:
- Remote QP Certification
- Safety feature and Serialisation
- Mutual Recognition Agreements and alike
- Brexit and consequences
- Importation from third country and QP responsibilities
- QPs for manufacturers of Active Pharmaceutical Ingredients (APIs)
The draft will be reviewed by the EQPA Board of Directors and Afshin Hosseiny (ECA) and amended where necessary.
Article
An EQPA statement regarding Brexit and QP certification, which was published via ECA newsletter, generated a lot of interest. James Strachan, Deputy Editor of the “The Medicine Maker” (www.themedicinemaker.com) contacted EQPA because of this. He was writing an article citing parts from the text in a publication.
IMP Working Group
The IMP Working Group has updated the Board’s charter to reflect the current changes in the IMP Board.
As a result of the significant interest and feedback following the excellent discussions at the 2019 IMP Pre-conference in Munich, the IMP QP Working Group board is setting-up a Task Force dedicated to the legal framework for the release/certification of medication for Compassionate Use, Named Patient Use and Early Access Programs across different EU countries including the UK. The name of the Taskforce „Early Access Task Force“- The Task Force systematically captures and presents QP relevant requirements including potential local differences to the IMP QP Board. The group of around 30 participants is chaired by Andreas Schwinn, meetings and information exchange is done via telephone- and video-conferences. The group has drafted a questionnaire to help to creating a summary of regulatory requirements for Early Access relevant for QP release across the EU/EEA and the UK.