The European QP Association is quite active in supporting its members. What has been achieved in 2020 so far?
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.
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.
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.
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.