| • Report by the SC on issues raised by Forum members during the 1st Outreach Forum meeting in Brussels in June 2012 |
| • Overview of the analysis by OIE on the results of the survey |
| • Topics “out of the scope of VICH” – how and by which organisation should they be addressed |
| • Feedback on practical issues related to specific VICH guidelines arising in the Forum members’ countries/regions - Questions from Argentina - ANZ explanation on the observer status - Presentation from South Africa - Presentation from Russia - Chinese Taipei's report |
| • Role of VICH and VICH GLs in marketing authorizations – presentation and discussion |
| • Example: overview and explanation of specific VICH GLs: Stability GLs - FDA described the specificities of VICH Quality GL3 (Revised) on Stability Testing of New Drug Substances and Products - FDA explained the development of Guidelines in general in the USA |
| • How Forum members can comment on VICH concept papers and VICH draft guidelines, and making these comments available to VICH - EU - FDA |