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|---|---|---|---|
| 001 | 978-3-031-73596-7 | ||
| 003 | DE-He213 | ||
| 005 | 20251030113301.0 | ||
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| 008 | 241107s2024 sz | s |||| 0|eng d | ||
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_a10.1007/978-3-031-73596-7 _2doi |
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| 100 | 1 |
_aMurphy, Heather. _eauthor. _4aut _4http://id.loc.gov/vocabulary/relators/aut _987142 |
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| 245 | 1 | 2 |
_aA Guide to Pharmacovigilance Audits in the USA _h[electronic resource] / _cby Heather Murphy. |
| 250 | _a1st ed. 2024. | ||
| 264 | 1 |
_aCham : _bSpringer Nature Switzerland : _bImprint: Springer, _c2024. |
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| 300 |
_aXII, 146 p. _bonline resource. |
||
| 336 |
_atext _btxt _2rdacontent |
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| 337 |
_acomputer _bc _2rdamedia |
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| 338 |
_aonline resource _bcr _2rdacarrier |
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| 347 |
_atext file _bPDF _2rda |
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| 505 | 0 | _aChapter 1 Introduction -- Chapter 2 Audit Types -- Chapter 3 PV Audit Preparation -- Chapter 4 PV Audit Conduct -- Chapter 5 Audit Report -- Chapter 6 Dos and Don’ts of a successful audit. | |
| 520 | _aPharmacovigilance 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. | ||
| 650 | 0 |
_aPharmacology. _967844 |
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| 650 | 0 |
_aPharmaceutical chemistry. _967843 |
|
| 650 | 0 |
_aPharmacy. _964666 |
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| 650 | 1 | 4 |
_aPharmacology. _967844 |
| 650 | 2 | 4 |
_aPharmaceutics. _967846 |
| 650 | 2 | 4 |
_aPharmacy. _964666 |
| 710 | 2 | _aSpringerLink (Online service) | |
| 773 | 0 | _tSpringer Nature eBook | |
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_iPrinted edition: _z9783031735950 |
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_iPrinted edition: _z9783031735974 |
| 776 | 0 | 8 |
_iPrinted edition: _z9783031735981 |
| 856 | 4 | 0 | _uhttps://doi.org/10.1007/978-3-031-73596-7 |
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