EMEA Presentation 1 (2009-09-24)

The purposes of the presentation is demonstrate and present Drugle to EMEA and the e-SPC project.



  • Magnus Gruvén


  • Paul Cohen assisted by Daniel Rodríguez.

EMEA participants:

  • Jim.Slattery @ emea.europa.eu
  • Paolo.Alcini @ emea.europa.eu
  • Steven.LeMeur @ emea.europa.eu
  • Benedicte.Cappelli @ emea.europa.eu
  • Ana.Hidalgo-Simon @ emea.europa.eu
  • Marie-France.Lefebvre @ emea.europa.eu (cannot make it)
  • Nick.Halsey @ emea.europa.eu (cannot make it)


Time: 9-10.30am UK

The meeting is takes place using the Vitero Virtual Conference program.

We should be logged in to the Viter/EMEA Drugle Demo virtual conference room by 08.45 (GMT).


0. Rationale: From what we know of your project and work, we believe that our tool can be of assistance in your work.

1. Verbal presentation based on the contents of the first Wiki page, ie the summary project description! Current work:

  • Development of detailed profiles for a few specialized healthcare areas.
  • Extraction of Undesired effects tables from SPC documents in order to generate graphical and sortable tables in the web client.

2. Demonstrate drugledemo.seibostudios.se. Don't show in broad browser window! Caveat: this demo is not specially adapted for EMEA. The following searches can be shown:

  • "abdominal pain" (Normal profile & Doctor). Note: MHRA & EMEA, Search hits are sections in SPC, Note difference in "Normal" and "Doctor" profiles. Expand sections without browsing.
  • "dukoral (Normal profile). Note: Different EMEA languages. Advanced -> Search english.
  • "trombyl". Note: No SPC since Trombyl is a Swedish product name and we have not yet included Swedish Drug Agencies SPC:s. We do get a hit in Kloka listan which a shortlist of recommended drugs published by the Healthcare Department of the Stockholm City Council.

3. Possible amendments to Drugle that could aid the EMEA project:

  • Create a separate password protected Drugle installation tailored for EMEA use. EMEA Drugle!
  • Use only SPC:s and EMEA ADR reports as the indexed sources for EMEA Drugle.
  • Develop a EMEA ADR analytics profile that gives highest relevance to SPC sections 4.8 and 4.4.
  • Improve search relevance ratings based on for example ATC codes, pharmacotherapeutic group, MedDRA system organ class and frequency ratings.
  • An automated process for ADR signal detection based on indexing new ADR:s every night could be set up.
  • Note that some of the indexing & analysis tools have discovered formatting problems in the SPC PDF files (missing section 4.8)

4. Discussion. Emphasize:

  • We have long experience of working with medical informatics.
  • We are are approaching the problem from a software engineering/algorithmic perspective.
  • We are not applying data warehousing techniques, which often lead to huge data synchronization problems. We are focusing of information retrieval from existing online data.
  • We are applying state-of-the art Google style search algorithms (probabilistic search models) and modern sorting and relevance analysis tools.
  • We implement adaptive algorithms that can continously be improved via terminology analysis and profile and filter development.
  • We are currently working on including all SPC:s from all drug approval agencies in EU.
  • We are currently working on extracting and indexing the contents of the following SPC sections that are important in supporting pharmacological vigilance:
    • 4.8 (Undesirable Effects).
    • 4.4 (Special warnings and precautions for use).
    • 4.5 (Interaction with other medicinal products and other forms of interaction).
    • 4.6 (Pregnancy and lactation).
  • We are looking for participating and funding partners with an interest in our services and tools.