1. Advisory Forum, 29-30 September 2005 Producing guidelines Johan Giesecke

2. Advisory Forum, 29-30 September 2005 Targets To assure: –Standardization –Timeliness –Flexibility –Acceptance and compliance in EU MS Need to balance top-to-bottom and bottom-to- top processes ?

3. Advisory Forum, 29-30 September 2005 Until next AF ECDC will look into the 'international' ones – WHO, CDC, etc. You are asked to look into your national guidelines: What already exists? Useful for Europe? Gaps?

4. Advisory Forum, 29-30 September 2005 Four parts A.Set priorities B.Select Working Party members C.Produce guidelines D.Assure acceptance

5. Advisory Forum, 29-30 September 2005 A. Setting priorities

6. Advisory Forum, 29-30 September 2005 Prioritisation criteria CriteriaGrade Public Health importance0 to 5 Differences in policy between MS0 to 3 Differences cause difficulties0 to 3 Existing guidelines are weak, not up to date, not evidence based, inconsistent, not appliable to the EU context 0/1 for each item (total: 0 to 5) Political desire, media pressing, enthusiasm of National Institutes 0/1 for each item (total: 0 to 3) Substantial resources committed0 to 3

7. Advisory Forum, 29-30 September 2005 Already suggested themes (1) contact tracing and prophylaxis for –(i) meningococcal meningitis (or other infectious disease) after a case on an aeroplane, train, boat, etc prophylaxis (gammaglobulin, vaccination) for contacts of hepatitis A testing for MRSA carriage in health-care workers and patients moving between countries TB contact tracing public health measures in epizootics of avian flu (already being looked into)

8. Advisory Forum, 29-30 September 2005 Already suggested themes (2) restricting social interaction (quarantine, school closures etc) in influenza pandemic screening immigrants (TB, HIV, etc where not covered by IHR regulations) defining which food-borne outbreaks should be reported under the new zoonosis directive

9. Advisory Forum, 29-30 September 2005 B. Selection of Working Parties

10. Advisory Forum, 29-30 September 2005 Two options 1.Pre-defined list by MS/AF 2.Contact AF for names when needed

11. Advisory Forum, 29-30 September 2005 Option 1: Formation of a large database of experts from each MS Each MS, under the coordination of the AF representative, selects a roster of experts Each MS defines its own rules for the selection The database may be updated on a regular basis The fields of interest of each expert are recorded in the database by a keyword system

12. Advisory Forum, 29-30 September 2005 Option 1: Choosing from database When required a WP is defined by SAU and appropriate SP(s) Members of WP are from: –the database of experts –SPs –the list of experts not included in the SPs taking into account criteria for geographical and disciplinary/professional representation A WP should be composed of 6-10 members

13. Advisory Forum, 29-30 September 2005 Option 2 Just like the Commission, the ECDC is responsible for forst draft of any guidelines Head of SAU contacts AF by email for already existing papers in each MS, that could be used – and for name of contact person Translations ECDC brings in additional help ("Working Parties") as needed

14. Advisory Forum, 29-30 September 2005 C. Work of the parties

15. Advisory Forum, 29-30 September 2005 Preliminary search and systematic review ECDC and AF collaborate to collect all available scientific and technical documentation, including existing guidelines from EU and non-EU countries Systematic literature review – task for the Panels?

16. Advisory Forum, 29-30 September 2005 Draft document and scientific consensus ECDC prepares a preliminary version of the guideline according to –collected documentation –literature review –its own knowledge and technical expertise Draft reviewed AF Put on website for wide comments?

17. Advisory Forum, 29-30 September 2005 Definitive document production and approval ECDC collects every opinion from both scientific and technical aspect Final draft seen by AF ECDC Director approves the guideline

18. Advisory Forum, 29-30 September 2005 D. Assure ownership (most important)

19. Advisory Forum, 29-30 September 2005 Acceptability assessment Acceptance and compliance in each MS should play a keyrole in the guideline delivery process AF members should assess acceptance according their own rules and depending on the complexity of the guideline Public or restricted conferences could be organised in the MSs

20. Advisory Forum, 29-30 September 2005 Diffusion and monitoring SAU provides as wide as possible diffusion of the guideline Monitoring of guideline implementation in MSs should be a task by SAU and AF members Specific surveys could be undertaken

21. Advisory Forum, 29-30 September 2005 Questions to AF 1.List of priorities to be decided at next AF meeting. Input from you needed during October.  to Work Plan for 2006 2.Roster of WP experts or nomination each time by AF? 3.Pre-publication of draft on ECDC web site? 4.How follow up acceptance and implementation?

22. Advisory Forum, 29-30 September 2005 Guidelines Factory Inc.