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DoubleTree by Hilton - London - Westminster

Jun 05, 2019 8:00 AM - Jun 06, 2019 3:30 PM

30 John Islip Street, London, SW1P 4DD, United Kingdom

Pharmacovigilance Strategies Workshop

Navigating the changing PV landscape in your daily work

Session 3: Inspections – Hot Topics

Session Chair(s)

Maria  Wishart

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)

Elsa  Ferrao

Reference Safety Information - Findings

Elsa Ferrao

INFARMED, Portugal

Pharmacist

Carrie  Scott

License Partner Audits

Carrie Scott

Abbvie, Portugal

Head, Global PV Compliance and Policy, Pharmacovigilance & Patient Safety

Dana  Isleem

Saudi Inspections

Dana Isleem

Bristol-Myers Squibb , Saudi Arabia

Pharmacovigilance Manager

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