VICH Outreach Forum OIE contribution 2 nd meeting of the Forum members Washington, 19 – 20 February 2013 S. Munstermann, JP Orand, C. Lambert

Overview  Feedback to OIE and Forum members since 1 st Outreach Forum meeting  VICH needs assessment survey  Distribution/Response  Priority GLs for translation  Use of GLs in Forum member countries  Topics for discussion at Forum meetings  Training needs  VICH page on OIE website  VICH general document

FEEDBACK TO OIE MEMBERS

Feedback to OIE and Forum countries Objective: To inform all 178 OIE members about progress made to bring non-VICH countries together in the Forum To inform Forum members unable to attend the BRX meeting about the outcome To request Forum members for nomination of “Focal persons” to attend Forum meetings in a sustainable manner

Response to the Feedback action - nomination of members - Country requestedCountry nomination received ArgentinaNo ASEANYes, but decline ChinaYes BrazilNo* Burkina FasoNo IndiaYes IndonesiaNo MalaysiaNo MarocNo MexicoYes KoreaYes RussiaYes South AfricaNo TaiwanYes ThailandYes UEMOAYes UkraineYes

NEEDS ASSESSMENT REGARDING VICH GL

VICH needs assessment survey - distribution and response - Survey distributedSurvey submitted ArgentinaYes ASEANNo Camevet ChileYes El SalvadoreYes CubaYes CanadaYes * ChinaYes BrazilYes Burkina FasoNo IndiaNo IndonesiaNo MalaysiaYes MarocYes MexicoYes KoreaYes RussiaYes South AfricaYes TaiwanYes ThailandYes UEMOAYes UkraineYes Distributed to 15 countries 3 REC Replies received 12 countries (+4) 2 REC (Camevet indirect)

Priority GL for translation - overall ranking - Rank 1 = GL 3R (Stability testing of new drugs substances) Rank 2 = GL 9 (Good clinical practices) Rank 3 = GL 29 (Pharmacovigilance: Mngt of PSUs)

Analysis by language Analysis by language Rank 1: GL 3R  Spanish, Portuguese, Thai, Ukraine  Rank 2: GL 29  Rank 2: GL 9  Spanish, French, Malay, Korean   Rank 3: GL 29  Spanish, French  Spanish, Malay, Ukraine

Use of existing Guidelines - modified GL 43 – TAS GL 3R – Stability GL 7 – Anthelmintics GL 9 – GCP GL 12 – Anthelmintics bovinve

Use of existing Guidelines - original Sta GL 3R – Stability GL 6 – EIA for VMP, I GL 9 – GCP GL 17 – Stability GL 38 – EIA for VMP, II

Topics for discussion at Forum meetings VICH organization  participation in expert groups  Suggestion of topics for GLs GL oriented (proposals or reviews)  Efficacy of combined products  New active ingredients  Stability testing for VMP & medicated premixes  Safety of new biotechnology animal vaccines  Bioequivalence studies for VMP  Efficacy studies for NSAIDs Approaches/strategies  Common (by region?) technical doc for VMP registration  Pharmaco-vigilance system in non-VICH countries – possible role for VICH?

Topics considered outside the scope of VICH A number of topics were proposed that are outside the scope of VICH, e.g. State control and monitoring of quality of VMPs How to control MRLs in VMPs this observation has triggered a special presentation at this Forum addressing the scope of VICH

Training needs - training in specific GLs - Rank 1: GLs 6, 9, 29, 38 Rank 2: GL 2

Prioritisation by category Rank 1: Quality GLs - 1, 2, 3,4,5,10,11,39,40 Rank 2: EIA GLs – 6, 38 Pharmacovigilance - 24,29,30,35,42 Rank 3: Good clincical practices – 9 MRK Gls - 46,47,48,49

Comparison of results Translations requested 1. 3R Use of GL – modified Use of GL – original R 2.3R, 2.6, 9, 17, , 9, 12 Training requested 1.6, 9, 29; , 24, 39 Interpretation to be discussed!

Webpage on OIE website

Translated GLs on OIE website A page dedicated to VICH was created on the OIE website The existing translated GLs are made available as pdf, with reference to the origin

General VICH document

Revision of the VICH General documents SC members and OIE gave input to the revision of the VICH General document For further discussion at the meeting: ◦Does it address some of the expressed needs of Forum members now?