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Session 3: Inspections – Hot Topics
Session Chair(s)
Maria Wishart
Medical Director, Global Patient Safety
Astrazeneca, United Kingdom
Achieving a successful outcome in an audit or inspection is, for many PV leaders, a formal objective. But what does ‘success’ look like? And how realistic are the goals we set ourselves, as we struggle to find ways to comply with dynamic and non-harmonised global regulations, to understand the nuances of newly established inspectorates and to agree amongst ourselves as industry professionals pragmatic, efficient and useful inter-company processes to assess compliance of our partners. We will focus on some particular areas of concern in this session and bring some thought-provoking ideas to the table for discussion.
Speaker(s)
Reference Safety Information - Findings
Elsa Ferrao
INFARMED, Portugal
Pharmacist
License Partner Audits
Carrie Scott
AbbVie Ltd, Portugal
Head, Global PV Compliance and Policy, Pharmacovigilance and Patient Safety
Saudi Inspections
Dana Isleem
Bristol-Myers Squibb , Saudi Arabia
Pharmacovigilance Manager
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