Presentations from the 2nd VICH Outreach Forum Meeting (Washington DC, 19-20 February 2013)

 
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