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Building the Scientific Bridge for Comparability of Combination Products
Location:
US Pharmacopeial Convention
12601 Twinbrook Pkwy Rockville, MD 20852-1717
Date:
November 30, 2017
Time:
8:00 AM - 4:30 PM ET
Credits:
7.00 RAC

Bridging the Scientific Bridge for Comparability of Combination Products describes the importance in the combination product development process of building a bridge for the drug and/or device constituent part and outlines important considerations for comparability bridging studies.

  • List Price: $600.00

As combination products become an increasingly important component of the pharmaceutical product portfolio, building a strong scientific bridge for the drug and/or device constituent part is vital. Indeed, the recently passed 21st Century Cures Act contains new statutory provisions aimed at...

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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