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The Pharmaceutical Regulatory Process
Engelsk
Bogcover for The Pharmaceutical Regulatory Process af , 9781138381285
Specifikationer
Sprog:
Engelsk
Sider:
492
ISBN-13:
9781138381285
Indbinding:
Paperback
Udgave:
2
ISBN-10:
1138381284
Udg. Dato:
7 jun 2019
Størrelse i cm:
22,9 x 15,2
Oplagsdato:
7 jun 2019

The Pharmaceutical Regulatory Process

Engelsk
Paperback 2019
Format:

Bog beskrivelse

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 compliance
  • pharmacovigilance programs designed to prevent widespread safety issues
  • legal issues surrounding the sourcing of foreign APIs
  • the issues of counterfeit drugs
  • updates on quality standards
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Specifikationer
Sprog:
Engelsk
Sider:
492
ISBN-13:
9781138381285
Indbinding:
Paperback
Udgave:
2
ISBN-10:
1138381284
Udg. Dato:
7 jun 2019
Størrelse i cm:
22,9 x 15,2
Oplagsdato:
7 jun 2019
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