Presentaciones de la 4.ª reunión del foro de divulgación de VICH (24 y 25 de junio de 2014, Bruselas, Bélgica)

2. Report by the SC on issues raised by Outreach Forum members during the 3rd Outreach Forum meeting in Auckland in November 2013

3. Report by OIE on their activities concerning VMPs since the last VICH Outreach Forum

5. Report from SC discussions on the TFs on concept papers:
- Revision of GL 3(R ) on stability to address climatic zones III and IV; results of the OIE survey on mandate of VICH for work
- Development of guidance on efficacy studies for combination products

6. Link between legal framework of VMP regulation and VICH GLs
- Presentation of approach by a VICH member and a VICH observer country (focus on implementation of TABST) - Japan / Canada
- Implementation of VICH GLs - EU

8. Reporting back to plenary on outcome of group discussions - Questions/discussions
Group 1
Group 2
Group 3

9. Updates from Outreach Forum members
Reports on practical issues related to VICH guidelines arising in the Outreach Forum member countries/regions :
9.1.Presentation from Russia: implementation of new pharmacovigilance regulation
9.2. Presentation from Morocco: registration of VMPs by ONSSA
9.3. Presentation from ASEAN

10. Presentation from the Tanzanian FDA
Missions related to veterinary medicinal products

11. Specific issues
11.1 Generics : Definitions and related terms - EU / USA / Japan
11.3. 11.3 Waiving TABST vaccines - Japan

12. Participation in the VICH process:
12.1. How to comment on a draft VICH guideline? - ANZ

15. Presentation of the 5th VICH public Conference in Japan