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On-demand Webcast: New Ways to Approach Market Access in the Changing Healthcare Marketplace

An on-demand recording of the RAPS Webcast, New Ways to Approach Market Access in the Changing Healthcare Marketplace, originally recorded on 15 June 2016.


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In an effort to improve market access, companies are struggling to communicate the value of their product to customers and stakeholders. This webcast will help regulatory professionals think about how to use the drug development process to obtain those improvements. It is clear that...

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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