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The leadership team of EQPA’s IMP Working Group recently held this year’s second team meeting in Brussels. The main focus of this latest working group meeting was on interaction with regulatory authorities and recent guidances issued for comments, an update from the QP to QP agreement task force and an intensive discussion around the set-up for the IMP Pre-conference and IMP parallel session for the upcoming QP Forum 2016 in Madrid.
Interaction with Regulatory Authorities
The interaction with regulatory authorities is an ongoing discussion topic and the IMP QP Working Group leadership team has been asked by the EQPA Board to propose potential topics for an EMA interested parties meeting. Several topics have been identified and forwarded to the Board and these will be shared with the entire IMP Working Group as soon as they are formally accepted. Please note that we welcome your own proposals for topics you would like to be considered and these can be forwarded to us through the IMP QP mailbox at
impqp@qp-association.eu.
New Guidances open for Comments
New Guidance has been reviewed and is open for comment from the entire IMP QP Working Group. Please find the attached links to the:
– consultation document “Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)”
>> Please use the
Commenting Template
by 15 August 2016 and
– draft of the revised “guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials”,
>> Please use the Commenting Template by
30 September 2016
Please bear in mind that we will be looking to take advantage of the opportunity to comment on proposed legislation to ensure that, as far as possible, the passed legislation meets the aim of increasing patient safety without placing undue burden on the process and duties of the QP. Thus please use the commenting templates above and return them to
IMPQP@qp-association.eu. We will then consolidate your input and pass it on in the name of European QP Association’s IMP QP Group.
Task Force Update
A short update was also provided by the Task Force on “QP to QP agreement”. QP to QP agreements from various companies were summarised and then subject to intensive team discussion on the differences seen with the aim of potentially finding a common view on this type of contract: The ultimate goal is to develop a generic template that IMP QPs can download from the EQPA website.
Implications of Brexit for QPs
In line with recent events, the
implications of Brexit were discussed briefly. In the first instance a statement “What does Brexit mean for the QP” has been prepared by the EQPA Board and is published on the Website, but undoubtedly the debate on this issue will continue to develop over the coming months and even years and, as always, we will do our best to keep the IMP QP community informed.
IMP Pre-Conference at this year’s QP Forum
This year’s IMP Pre-Conference, entitled “IMP QPs shedding light on the grey spaces” will include a series of lectures, interactive case studies together with what has become the well-established and much appreciated question & answer sessions. Lectures from both regulatory and industry perspectives will aim to shed some light on the subject of Advanced Therapy Medicinal Products (ATMPs). Following that, speakers and audience – including a number of representatives from Regulatory Authorities will jointly look at the most recent legislation impacting IMP QPs. Sharing experiences and exchanging ideas is an integral part of the meeting. Continuing on, we will be assessing the output from the “QP to QP agreement” Task Force. A brief overview of Risk Assessment tools will be followed by the practical application of these in roundtable discussions on IMP specific processing steps; risks of unblinding medication in a blinded trial and the potential risks of not including excipients in the IMP supply chain diagram. Plenty of time will be dedicated to interactive Q&A sessions; as in previous years, the results of these sessions will be made available on the IMP QP area of the EQPA website after the conference.
The IMP parallel sessions this year will be dedicated to the subject of “Quality oversight of IMP QPs in global supply chains”. Please feel free to
submit specific questions on this area of activity which you would like to discuss with your IMP QP colleagues at the QP Forum. Just send them to
impqp@qp-association.eu.
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