The European QP Association is quite active in supporting its members. What has been achieved in the past six months?
The IMP Working Group has sent summarised comments to EMA on the draft of the Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice. The public consultation started end of May.
The ECA Good Practice Guide No. 2 "Duties and Responsibilities for Qualified Persons in the EU" has been amended and published on the EQPA Website. Two new chapters have been added:
See the amended Good Practice Guide (requires login).
On 28/29 August, a joint ECA/EQPA conference was held in Chicago, USA. The objective was to share information and experience and on discussing the critical areas of European GMPs and the QP's daily work.
The 13th QP Forum was held in Prague on 29/30 November with three pre-conference Sessions on the 28th. More than 250 participants and 30 speakers met to exchange experiences with colleagues and to establish contacts and networking possibilities. The QP Forum was rated 1.55 (1 = very good, 6 = poor). This is an excellent result and the second best of all QP Forums so far!
The IMP Working Group has compiled a survey on the "order" as referenced in Annex 13 section 8 and in the Detailed Commission Guidelines section 5.2. The IMP Working Group thinks that the guidance does not provide the industry with clear instructions. Aim of the survey was to get a benchmark of current industry practice and to discuss this at the IMP QP Pre-conference in November. The Working Group was looking for only one completed survey per company to get consolidated information.
The EQPA further conducted a survey to get an overview about QP Liability and the possibilities for insurance. The results were summarized and published on the website. Publication in the EQPA Members' Letter will follow.
In another survey EQPA asked members to describe approaches to the delegation of QP tasks according to Annex 16 sections 1.7.1 -1.7.21 and Annex 13 section 40. The results were published in the download area of the IMP Working Group. A report on this survey was also part of the latest EQPA Newsletter issue.
Here you get to the survey results (requires login).
Together with EFPIA and other industry associations, Ulrich and Georg have written a letter to EMA based on the outcome of a teleconference organised by EFPIA. The call was proposed following the EMA announcement cancelling the EMA-IWG-IPM. The intent is, that irrespective of the cancellation of the IWG meeting with EMA and the continuity plans of EMA, the stakeholders want to point out that discussions need to continue.
In an answer to this letter, EQPA was invited to attend a telecon with EMA secretariat and other EU (trade) associations for 16 January 2019 to discuss a status update.
Update website: in a new section of the website visitors will find "Brexit"-related information that is relevant for you as a QP in a so called "Brexit Corner".