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EU GMPs with Annex 15 Qualification and Validation QMSR ICH E2E Pharmacovigilance Planning

SKU: 3277582039

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Description

ICH E2E Pharmacovigilance Planning

Includes EU Clinical Trial Directive

Specifically designed for Device Manufacturers

5 x 11 Manual September 2008

Includes Annex 11 Computerized Systems and Annex 15 Qualification and Validation

EU GMPs with Annex 15 Qualification and Validation QMSR ICH E2E Pharmacovigilance PlanningThe EU GMPs include Chapters 1 9 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary. Includes Annex 15 Qualification and Validation

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