Welcome to the ConcePTION October 2024 newsletter

In this newsletter you will find the following:

– News from the Consortium

    • ConcePTION close-out event
    • ConcePTION white paper
    • MUMS stakeholder meeting and webinar
  • – Overview of deliverables and milestones achieved in 2024
  • – Recent project publications
  • – Lists of delayed & upcoming deliverables and milestones
  • – Updates from the PMO
    • Certificates on the financial statements (CFS)
    • Publications
    • Final stretch: The last quarter of ConcePTION

News from the Consortium 

ConcePTION close-out event 

The IMI ConcePTION close out event is scheduled for Thursday 21 November at the EGG in Brussels. The meeting runs from 11am to 4pm. Our overarching aim for the event is to facilitate a clear transition from the IMI Consortium which formally disbands at the end of 2024 to a new entity so that our vital work can continue. Specifically, our objectives are:

  • To reinforce our ‘why’ and the critical importance of our work.
  • To celebrate our achievements of the past five years.
  • To provide short updates on our plans to sustain key workstreams.
  • To set out our vision for our proposed ‘Alliance’ and clarify our policy proposals.

 Invitations are being sent out at the moment. If you have any suggestions for invitees, please do not hesitate to reach out to the PMO.

ConcePTION white paper: our 10/10 ambition 

A first outline of the white paper has been formulated, which highlights the importance and urgency of assuring that high quality evidence about medicine use during pregnancy and breastfeeding is available to citizens and health care professionals; analyses why the current situation does not suffice, but that it can be remedied; and provides a clear and appealing perspective on realistic actions/policies that can be implemented to resolve the issue. To provide a set of clear and appealing goals, we want to build the paper around 10 activities that will have had a significant impact 10 years from now.

These 10 identified activities will fit within the themes of evidence generation, dissemination of evidence and communication and coordination fragmentation. The proposed ten activities will also drive the content of the ConcePTION close out event.

The ConcePTION Managing Board have given a preliminary approval to proceed with the current plan for the white paper, and some content specialists have been identified. However, much work is still to be done. If you wish to contribute to the white paper, please contact Pieter Stolk at [email protected].

MUMS* Expert Workshop advances sustainability plans  

On 23 and 24 September 2024, the MUMS and IMI ConcePTION team hosted a workshop, attended by over 30 experts from across Europe, to help shape our future plans for the MUMS website.

  The purpose of the workshop was to invite opinion on:

    • The best options for evolving the current prototype of 38 medicines to platform with at least 200 medicines.
    • Our priority audiences and how best to reach them.
    • Potential future funding options and how we might approach them.

 The interactive agenda enabled us to gather extremely constructive feedback on our plans to develop the platform; in particular in understanding the specific needs of various countries to ensure it is positioned and ‘marketed’ in the most effective way.  

 Our next steps are to use this feedback to create a clear proposal for moving forward, and to continue our conversations with key stakeholders to explore the funding options discussed. In the meantime, we are preparing a full report which we will share with the group in the near future.

Additionally, on Wednesday 10 October 14:00 CET, the MUMS team will give a webinar on ‘Providing trusted information on the use of medicines during pregnancy – MUMS knowledge bank & e-learning for health care professionals’. You can register for the webinar here.

 *Mothers Using Medicines Safely

Overview of deliverables and milestones achieved in 2024 

WP

No.

Description

Submitted

Lead

1

D1.5

Submitted manuscript of a guidance document outlining standards for conducting medication utilisation studies in pregnant women (data collection and analytic standards) for established and newly marketed products

Feb 9

THL

3

D3.8

Individual PBPK model for predicting exposure of infants to selected drugs

Jan 17

KUL

4

D4.5

Protocols for 5 approved demonstration studies uploaded on EU-PAS register

June 19

UOSL

5

D5.14

Annual reports on external communication results for impact assessment -5

April 12

NUTH

5

M20

Knowledge database is ready for entry of information

Jan 31

LAREB

7

D7.12

Wiki page with description of tools and GITHUB repository 2nd

May 14

UMCU

7

D7.15

Final FAIR data catalogue including negotiation services and authenticated space for simple analytics on data characterization output

April 16

UMCU

7

D7.16

Report with publications on results of component algorithms

Sep 04

ARS

7

D7.18

Report confirming all relevant documents for using, producing or collecting human cells or tissues (e.g. ethics approval, import licence, accreditation/designation/authorisation/licensing) prior to start of research raising ethical issues are on file

Feb 13

UMCU

7

D7.19

Report providing the details on the informed consent procedures, informed consent sheets and information sheets for demonstration studies in WP2 & 5 . IRB approval procedures and confirmation for WP2 demonstration studies and WP5 outreach

Feb 13

UMCU

7

D7.20

Templates and guidance for local and central Data Privacy Impact Assessments for datasources and repository for continuous collection of completed forms and approvals

Feb 13

UMCU

7

D7.21

Report providing the details on the informed consent procedures, informed consent sheets and information sheets for demonstration studies in WP4. IRB approval procedures and confirmation for WP4 demonstration studies.

Feb 13

UMCU

7