Consultation on VICH Concept Papers and Draft Guidelines

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Presentation transcript:

Consultation on VICH Concept Papers and Draft Guidelines Comments made at VICH Outreach Forum February 20, 2013 BETTYE.WALTERS@FDA.HHS.GOV

WHY do consultations? Primary objectives Transparency Expertise

HOW is consultation managed? Each VICH member defines its own consultation methods OIE manages dissemination at world wide level and coordination to non-VICH regions

WHAT are benefits of consultation? Reduce conflict Reduce litigation Legitimacy to regulatory decisions Responsiveness Learning / training needs assessment Acceptance

Conclusion Gives Guideline and Concept Paper writers a chance to actively listen to a wide range of concerns, values, and preferences Consultation is valued because it impacts the outcomes of regulatory guidance and policy