Back to On-demand Webcast: Achieve Regulatory and Commercial Success for Your First Biopharma Product
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On-demand Webcast: Achieve Regulatory and Commercial Success for Your First Biopharma Product

An on-demand recording of the RAPS Webcast, Achieve Regulatory and Commercial Success for Your First Biopharma Product, originally recorded on 18 November 2015.


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Whether this is your first product launch or just the latest of many, obtaining timely FDA approval and considering key commercialization factors early in the development cycle are imperative to the continued success of your business. This webcast will help you navigate the complex US regulatory...

Back to On-demand Webcast: Achieve Regulatory and Commercial Success for Your First Biopharma Product
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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