Home > Books > Pharmacovigilance Medical Writing: A Good Practice Guide
Pharmacovigilance Medical Writing: A Good Practice Guide
View PDF

Pharmacovigilance Medical Writing: A Good Practice Guide

Publication Year: 2012
Edition: 1st
Authors/Editor: Orleans-Lindsay, Justina
Publisher: Wiley
ISBN: 978-1-119-96726-2
  • Description
  • Details
  • Collections

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.

  • Platform:
    Ovid
  • Publisher: Wiley
  • Product Type: Book
  • Author/Editor: Orleans-Lindsay, Justina
  • ISBN: 978-1-119-96726-2
  • Specialty:
    Pharmaceutical Science
    Pharmacology
  • Language: English
  • Edition: 1st
  • Pages: 286
  • Illustrations: 0
  • Year: 2012

Pharmacovigilance Medical Writing: A Good Practice Guide is included in the following Collections:

Free Instant Access
This Month

JOTM
Embase® The Embase database is the most trusted source of global, evidence-based pharmacological and biomedical research with over 30 million bibliographic records dating back to 1947.
JOTM
Visible Body Heart & Circulatory Premium This interactive 3D Atlas is a deep dive into the heart and circulatory system for learning, reference, and patient education.
JOTM
Circulation Research Presents peer-reviewed reports on research advances in biology, biochemistry, biophysics, cellular and molecular biology, morphology, pathology, physiology, and pharmacology.
JOTM
Regional Anesthesia & Pain Medicine Publishes peer-reviewed scientific and clinical studies to advance the understanding and application of regional techniques for surgical anesthesia and postoperative analgesia.

Noteworthy

Doody's Featured Books
Manual of Valvular Heart Disease
Portable and clinically oriented, this full-color handbook is a unique and timely guide to valvular heart disease and percutaneous coronary interventions.

Khonsari's Cardiac Surgery: Safeguards and Pitfalls in Operative Technique
Details the most important techniques in a concise, readable, and richly illustrated format, with a focus on avoiding and managing surgical pitfalls and complications.