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Sponsored Webcast: Writing Effective Test Reports and Persuasive Test Summaries
April 26, 2017
12:00 PM - 1:30 PM ET

You will learn about required elements of good test reports and important elements of test summaries. The goal is not just to improve your technical writing skills, but to improve your ability to persuade others of the safety and effectiveness of your product.

  • List Price: Free

Wednesday, 26 April 2017
12:00-1:30pm ET

Sponsored by:

Successful submissions include clear and compelling data demonstrating the safety and effectiveness of your product. Writing test reports that meet current regulatory and quality expectations is critical. But test reports can include a great...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design