A Guide to Pharmacovigilance Audits in the USA

Murphy, Heather

A Guide to Pharmacovigilance Audits in the USA
  • 出版商: Springer
  • 出版日期: 2024-11-08
  • 售價: $5,690
  • 貴賓價: 9.5 折 $5,406
  • 語言: 英文
  • 頁數: 120
  • 裝訂: Hardcover - also called cloth, retail trade, or trade
  • ISBN: 3031735951
  • ISBN-13: 9783031735950

    • 海外代購書籍(需單獨結帳)

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商品描述

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.

The scope is limited to the requirements based on the US Food and Drug Administration (FDA) Regulations. This is an ideal book for auditors and auditees who want to obtain practical PV auditing skills to use within the BioTechnology/Pharmaceutical Industry in the USA.

商品描述(中文翻譯)

藥物監測審核是製藥/生技公司日益重要的需求。有效進行這些審核需要具備專業的技能組合，並了解審核原則以及藥物監測的操作和法規知識。本書為審核員提供實用指導，告訴他們應該提出什麼問題、尋找什麼資訊以及要求哪些文件，以確保被審核者的藥物監測系統符合法規、合約要求和行業最佳實踐。

本書的範圍僅限於美國食品藥品監督管理局（FDA）法規的要求。這是一本理想的書籍，適合希望在美國生技/製藥行業獲得實用藥物監測審核技能的審核員和被審核者。

作者簡介

Heather Murphy is a expert Pharmacovigilance (PV) professional with her focus in Pharmacovigilance Operations and PV Audits. For over 20 years she has established PV and reengineered PV departments for companies in various stages of development within the pharmacovigilance industry. As a result of her "hands on" experiences she has successfully developed PV systems for small-large size companies in preparation for US and global product launch. PV Operations activities have ranged from the strategic to tactical with extensive experience in PV inspections including the FDA, EMA, PMDA, AIFA, Health Canada, MHRA, ANSM, BfArM and Swiss Medic.

Current PV audit activities include audits for/of preinspection preparation, routine and for cause, vendor qualification, REMS, business partner, contract resource organizations (CROs), specialty pharmacies, warehouse vendors, supply vendors, and distribution vendors.

She is a Certified Quality Auditor (CQA) through the American Society of Quality, obtained a MBA from Suffolk University in Boston, MA, a Bachelor of Science in Nursing (BScN) from Dalhousie University in Nova Scotia, Canada and an RN from the Prince Edward Island School of Nursing in P.E.I Canada.

作者簡介(中文翻譯)

Heather Murphy 是一位專業的藥物警戒 (Pharmacovigilance, PV) 專家，專注於藥物警戒操作和 PV 審核。在過去的 20 年中，她為藥物警戒行業中不同發展階段的公司建立和重組了 PV 部門。憑藉其實務經驗，她成功為中大型公司開發了 PV 系統，以準備美國及全球產品上市。PV 操作活動涵蓋從策略到戰術的各個層面，並在 PV 檢查方面擁有豐富的經驗，包括 FDA、EMA、PMDA、AIFA、Health Canada、MHRA、ANSM、BfArM 和 Swiss Medic。

目前的 PV 審核活動包括對預檢查準備、例行檢查和因故檢查、供應商資格、REMS、商業夥伴、合同資源組織 (CROs)、專科藥局、倉庫供應商、供應商和分銷供應商的審核。

她是美國品質協會 (American Society of Quality) 認證的品質審核員 (CQA)，在麻薩諸塞州波士頓的薩福克大學 (Suffolk University) 獲得 MBA，並在加拿大新斯科舍省的達爾豪斯大學 (Dalhousie University) 獲得護理學學士 (BScN)，同時在加拿大愛德華王子島護理學校 (Prince Edward Island School of Nursing) 獲得註冊護士 (RN) 資格。

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