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Introduction to Electronic Regulatory Submissions in the eCTD Format
US Pharmacopeial Convention
12601 Twinbrook Pkwy Rockville, MD 20852-1717
April 10-11, 2017
8.00 RAC

The Introduction to Electronic Regulatory Submissions in the eCTD Format program focuses on developing the critical competencies needed for regulatory professionals to develop publishing skills for preparing agency-compliant submissions.

  • List Price: $1,450.00
  • Member Price: $1,350.00
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If you are new to preparing submissions documents for FDA, this is the introductory course that will begin your understanding of the steps you need to comply with the May 2017 electronic submission requirements.

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

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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