ISO IDMP Task Force Meeting February 2016

Markus Pfahlert, Product Manager of LORENZ drugTrack, participated in the ISO IDMP Task Force Meeting in February and compiled this summary of the outcomes.

Representatives from EMA, NCA, industry, consultants and vendors participated in this meeting.

Referentials & Organisations
(click here to view the whole presentations: Referentials, Organisations)

Currently the Referentials Group is trying to create a common exchange process for distributing referentials lists. There are 2 different activity streams for each: 1) the gathering (or mapping of already existing data such as EVMPD) and 2) the distribution. For the latter, help from vendors will be needed on both the exchange process itself and for a User Acceptance Test (UAT) on building the exchange system.

The expected deadlines for providing sources for additional terms can be found on page 6 of the above presentation.

Key items in this presentation included:

  • EVMPD and IDMP codes will exist in parallel. Depending on which submission format is used during the transition, the applicable code will need to be submitted.
  • It is expected that NCA representatives will be nominated to support the process.
  • Members are requested to develop a possible process for updating and distributing referentials, including a proposal on how often the updates should happen.
  • Timelines for the mapping of all currently-known lists can be found on page 8 of the above presentation. Veterinarian lists have also been included, as they are also covered by IDMP.

UAT:
For EMA to save time and money on the project’s implementation, useful user comments that have been pre-discussed and “triaged” are essential.

UAT nominations (page 10) are required by the end of February 2016. Two focal points from among the task force vendors are asked to consolidate the results of all vendor testing. (Actual testers are not necessarily required to be members of the Task Force.)

Post meeting information: At a RMS teleconference on 09 March 2016 a preliminary object model and exchange model was presented, which is not yet available to the public.

A rough proposal on the referential object data model was presented to give the audience a broad understanding of the current status. This proposal will be refined for the final version. (see pages 11-13)

Many discussions were held on list usage, on processes and IDs (OIDs), but there’s no real outcome on any of these issues yet. (see pages 14-15)

It seems that the EMA is trying to force the first exchange of referentials by July 2016 in order to meet the timeline for several IDMP-related topics.

Substances & Products
(click here to view the whole presentation)

The presentation on Substances and Products heavily reflected requests from industry, which takes a product-centric approach. Industry representatives are pleading for:

  • Not lengthening the process of making substances & products available to patients
  • No re-entering of data
  • Consistency throughout the drug life cycle

EMA will discuss the process, and industry will continue to develop a proposal on how to implement it in detail, with particular focus on variations and other regulatory activity processes. However, the EMA will stay focused on referentials and data; and not on business processes. These are being escalated back to the telematics group.

Scope of Iteration 1
(click here to view the whole presentation)

Recommendation for PMS Iteration 1, Source: EU ISO IDMP Task Force Meeting– 19 February 2016 - Presentation - Agenda item 4: PMS iteration 1 - Analysis of the data efforts and value results and recommendation on the scope – Page 16

Source: EU ISO IDMP Task Force Meeting – 19 February 2016 – Agenda item 4: PMS iteration 1 – Page 16

The change in scope is not agreed, but it is likely to be swallowed by industry. Industry representatives are not happy at being forced to accept five additional fields.

Package description and granularity are also still subject to discussion. These both interlink with the falsification initiative and other discussions, so currently there is still no basis for a substantive discussion. The package description field is the only similarity to EVMPD, but this is unlikely to be used for migration.

Communication on IDMP
(click here to view the whole presentation)

Industry representatives will liaise with agencies to define timelines and communication channels.

Report on Falsified Medicines
(click here to view the whole presentation)

Report on SPL7
(click here to view the whole presentation)

The FDA stated that they have more or less already included these fields in SPL7.

Overall
The EMA has not committed to any timelines officially, nor have they stated that they accept that certain timelines will be missed. This comes despite the fact that in his part of the Products and Substances presentation, Andrew Marr clearly showed that the underlying ISO guidelines will be delayed until Q3 of 2016, possibly later.

The next onsite meeting in London will take place in June.


Markus Pfahlert
Written by Markus Pfahlert, Product Manager LORENZ drugTrack at LORENZ Life Sciences Group.

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