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6.00 RAC

Intermediate Medical Writing: Investigational Applications

Participants will be introduced to the components of each of the region-specific applications for drugs/biologics such as the Investigational New Drug Application (IND), Clinical Trial Application (CTA) and Investigational Medicinal Product Dossier (IMPD), as well as those required for investigational devices such as the Investigational Device Exemption (IDE) and Investigational Testing Authorization (ITA). these application types and learn techniques for improving document quality.

6.00 RAC

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Regulatory and medical writing is an integral part of the product development and approval process and plays a crucial role in assuring that submissions for new investigational products are well organized, accurate and reviewer-friendly.

This course provides an overview of the variety of...

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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