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Medical Writing For Regulatory Submission In Clinical Research

eBook (PDF), 3 Pages
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Regulatory medical writing in clinical trials requires medical writers to possess sufficient knowledge of the regulatory guidelines of concerned authorities of specific countries and needs to have dedication and commitment to handle large volumes of regulatory data. A professional regulatory writer needs to have sufficient understanding of the drug development process to determine the important documents that need to be written and submitted for regulatory submissions. Regulatory submissions challenges in clinical trials Regulatory Writing and Publishing poses many challenges for the medical writers in the writing and development of critical documents like Clinical Study Report, Investigator’s Brochure, and clinical trial protocol development and in the preparation of documents for FDA meetings and briefings.
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Product Details

ISBN
9781365796012
Edition
First Edition
Published
March 3, 2017
Language
English
Pages
3
File Format
PDF
File Size
79.57 KB

Formats for this Ebook

PDF
Required Software Any PDF Reader, Apple Preview
Supported Devices Windows PC/PocketPC, Mac OS, Linux OS, Apple iPhone/iPod Touch... (See More)
# of Devices Unlimited
Flowing Text / Pages Pages
Printable? Yes
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