05 November 2020
European QP Association Activities in 3rd Quarter 2020
What the European QP Association was working on in the third quarter of 2020 is summarized below.
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.
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.
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.
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