We use cookies to provide essential features and services. By using our website you agree to our use of cookies .


COVID-19 Response at Fishpond

Read what we're doing...

Targeted Regulatory Writing Techniques


Product Description
Product Details

Table of Contents

Regulatory writing fundamentals.- Developing a target.- Getting started.- Regulatory writing tips.- Templates and style guides: The nuts and bolts of regulatory documents.- Document review.- Source documents.- Protocols.- Clinical study reports.- Integrated documents.- Investigator's brochures.- Investigational medicinal products dossier.- Integrated summaries of safety and efficacy.- Informed consent forms.- Regulatory submissions.- Global submissions: The common technical document.- Clinical trial procedures and approval processes in Japan.- Region-specific submissions: United States of America.

Ask a Question About this Product More...
Write your question below:
Look for similar items by category
Home » Books » Science » Medical » Pharmacology
Home » Books » Science » Medical » Pharmacy
Item ships from and is sold by Fishpond World Ltd.
Back to top