Ira R. Berry – författare
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3 produkter
3 produkter
904 kr
Skickas inom 10-15 vardagar
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliancepharmacovigilance programs designed to prevent widespread safety issueslegal issues surrounding the sourcing of foreign APIsthe issues of counterfeit drugsupdates on quality standards
2 724 kr
Skickas inom 10-15 vardagar
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliancepharmacovigilance programs designed to prevent widespread safety issueslegal issues surrounding the sourcing of foreign APIsthe issues of counterfeit drugsupdates on quality standards
3 200 kr
Skickas inom 10-15 vardagar
Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.