European QP Association Activities in 4th Quarter 2020
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:
1. The EMA GMP/GDP -IWG Working plan 2021; covering progress on new/updated guidelines
2. Inspection and Audit Management in a changing environment
3. 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.