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PV Compliance DIY: How to Find and Fix Quality Issues Before They Find You
Session Chair(s)
Anna Adams, PHD
Head, PV QA Europe
Daiichi Sankyo Co., Ltd., United Kingdom
How do we learn from PV compliance failures? This session will provide insights from across industry and from the regulators on how to identify, prioritise and effectively fix non-compliance in PV, exploring the role of psychological safety in this.
Learning Objective : Describe how proactive approaches to investigating known issues, using a better understanding of psychological safety and learning from failure can help identify deeper root causes for future proofing compliance within the PV system; Explain how to build a proactive business case for identifying and addressing quality issues within the pharmacovigilance (PV) system and outline practical steps for initiating this work.
Speaker(s)
Panelist
Representative Invited
European Medicines Agency, Netherlands
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