Back to On-demand Webcast: Getting Ad-Promo on Board the eCTD Train
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On-demand Webcast: Getting Ad-Promo on Board the eCTD Train

An on-demand recording of the RAPS Webcast, Getting Ad-Promo on Board the eCTD Train, originally recorded on 6 April 2016.


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The electronic Common Technical Document (eCTD) has transformed submissions to the US Food and Drug Administration (FDA) and other regulatory authorities around the world. Until recently, that transformation had bypassed the ad-promo world. But, with the release of a new draft...

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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