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6.00 RAC

Pharmaceuticals: EU Regulations

This course provides an overview of the regulatory framework in the EU, including the EMA entities pertaining to medicinal product reviews. It also covers the various applications and registration procedures and the regulatory requirements throughout a product’s lifecycle.

6.00 RAC

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  • Member Price: $550.00

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The European Union (EU) unifies 28 Member States as well as countries in the European Economic Area (EEA), providing a single market for the pharmaceutical industry. The EU’s directives and regulations outline the requirements for the development, manufacture and marketing of medicinal products for...

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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