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Regulatory Submissions in eCTD Format: A Hands-On Approach
Location:
US Pharmacopeial Convention
12601 Twinbrook Pkwy Rockville, MD 20852-1717
Date:
April 12-13, 2017
Credits:
10.00 RAC

The Intermediate Course for Regulatory Submissions in eCTD Format focuses on developing the critical competencies necessary for regulatory professionals to develop publishing skills necessary for preparing agency-compliant submissions.

  • List Price: $1,450.00
  • Member Price: $1,350.00
 
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If you are currently preparing documents for FDA submissions and familiar with the process, but need to learn how to comply with the May 2017 electronic submission requirements, this course is for you.

The deadline is fast approaching for your company to migrate to electronic-only regulatory...

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» View the Table of Contents

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