Pharmacovigilance Medical Writing

Pharmacovigilance Medical Writing

4.11 - 1251 ratings - Source



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.A Good Practice Guide Justina Orleans-Lindsay. Element ... REMS Report Data Source Package Insert Medication Guide/ Drug Safety (Pharmacovigilance)/ Regulatory Affairs Communication Plan Drug Safety (Pharmacovigilance)/ Regulatoryanbsp;...


Title:Pharmacovigilance Medical Writing
Author: Justina Orleans-Lindsay
Publisher:John Wiley & Sons - 2012-06-22
ISBN-13:

You must register with us as either a Registered User before you can Download this Book. You'll be greeted by a simple sign-up page.

Once you have finished the sign-up process, you will be redirected to your download Book page.

How it works:
  • 1. Register a free 1 month Trial Account.
  • 2. Download as many books as you like (Personal use)
  • 3. Cancel the membership at any time if not satisfied.


Click button below to register and download Ebook
Privacy Policy | Contact | DMCA