Global Harmonisation Task Force SG2: Information exchange

1. Global Harmonisation Task Force SG2:Information exchange Dr. Ekkehard Stösslein Federal Institute for Drugs and Medical Devices Tel.: +49-228-207 5384; Fax: +49-228-207-5300 e.stoesslein@bfarm.de

2. Vigilance System of SG2 N36, Manufacturer’s Trend Reporting of Adverse Events N N Adverse Adverse Manufacturer´s investigation Manufacturer Event Event QMS QMS Trend? Trend? QMS Trend? N N N Report? Report? Y Y Y Y N21, Adverse Event Reporting Guidance N31, Reporting of Use errors N40, To whom Adverse Event Reports must be submitted National NCA (Central Database?) Regulator To Whom? To Whom? (Central Database?) N7, Minimum Dataset N32, Mfr Report Format Vigilance NCAReport Other National What content? Report? Other NCA´s Regulators Y Y N9, Format N20, Criteria for exchange N33, Timing of Adverse Event Reports When? Timeframe?

3. GHTF-Vigilance Report Exchange (1) SG2 N20R7: Competent Authority Reporting Criteria Criteria for the Exchange • seriousnessshould be linked with many of the following criteria • unexpectedness of incident/event • population vulnerable (e.g paediatric, unconscious patients) • preventability (useful recommendations) • public concern / outrage (radioactivity, infections ) • benefit/risk ratio, state of the art, alternatives • lack of scientific date (especially long term effects) • repeated device problems that re-surfaced • class I recalls or equivalent (in EU acc. to EN46001) • written notifications by one NCA to the public

4. GHTF-Vigilance Report Exchange (2) • 2 levels of information exchange • highly sensitive and/or confidential (e.g. on ongoing investigations) • selected public (non-confidential) information • active exchange by email via the NCAR secretariat in ENGLISH LANGUAGE • NCAR secretariat is responsible for checking the complet- ness of the report and maintaining the distribution list

5. Principle Rules for Exchange • contact mfr before sending out a report to other NCA´s • use NCA reporting form SG2 N9 latest version • if investigation is completed and NO action is required the report should not be exchanged actively • if investigation is not completed but actions are contemplated a report should be sent

6. Exchange (1) • started in January 1999 with a pilot pahse • about 100 reports have been exchanged between 1999 and December 2000 (DE ,UK, US, AU, NO, CH ) • regular exchange since January 2001 • about 618 reports (up to Mai 31st, 2004) have been exchanged • most NCA declare it to be a useful vehicle to exchange information about vigilance • example: DE-2004-09-06-150.doc • DE-2004-10-28-189.doc • requirements on how NCAs outside GHTF could participate on that exchange (SG2N38)

7. Application Process (1) • Associate Participant: An organisation that participates in the NCAR program that receives only public information (see definition of public information) from other NCAR participants. Associate participants may contribute NCARs that contain either public or confidential information, but are not compelled to do so. An associate participant may not necessarily be a National Competent Authority. • Full Participant: An organisation that participates in the NCAR program that receives both public and confidential information from other NCAR participants. Full participation is open only to National Competent Authorities.

8. Application Process (2) Applicant receives training. (there may be charges from trainer) Trainer Reference to SG2 Applicant’s Declaration to SG2 Application to SC Identify Trainer NCAR Program Member SG2 Chair Recommen-dation to SC SCApproval

9. Participation Requirements # Training regarding GHTF N9 and N20 only. * Full Training

10. For More Information See www.ghtf.org Thanks for Your Attention