A Guide to Pharmacovigilance Audits in the USA
English | 2024 | ISBN: 3031735951 | 158 Pages | PDF EPUB (True) | 16 MB
Pharmacovigilance Audits are an important and growing requirement for Pharmaceutical/BioTech companies. A niche skillset combined with an understanding of audit principles and pharmacovigilance operational and regulatory knowledge are required to effectively conduct these audits This book provides practical guidance to auditors as to what questions to ask, what information to look for, and what documents to request to ensure the auditee Pharmacovigilance System is compliant with regulations, contractual requirements, and industry best practice.
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