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Pharmacovigilance Medical Writing : A Good Practice Guide
by Ph.D. Justine Orleans-Lindsay


Overview - Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage).  Read more...

 
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More About Pharmacovigilance Medical Writing by Ph.D. Justine Orleans-Lindsay
 
 
 
Overview
Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.

 
Details
  • ISBN-13: 9781119967262
  • ISBN-10: 1119967260
  • Publisher: Wiley-Blackwell
  • Publish Date: August 2012
  • Page Count: 269
  • Dimensions: 8.4 x 5.4 x 0.5 inches
  • Shipping Weight: 0.65 pounds


Related Categories

Books > Medical > Pharmacology

 
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