Meeting Details

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Intermediate Course for DMF/ASMF/Module 3 Submissions in eCTD Format
Location:
Frankfurt Holiday Inn—Alte Oper
Mainzer Landstrasse 27 Bahnhofsviertel 60329 Frankfurt Am Main Germany
Date:
November 6-7, 2017
Credits:
10.00 RAC

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

  • List Price: $1,550.00
  • Member Price: $1,450.00
 
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If you are currently preparing and maintaining paper ASMFs and DMFs and/or Module 3 in eCTD for the EU, US, Canada and/or Switzerland and have to use the eCTD format, this course is for you.

The FDA’s May 2018 deadline mandates that you comply with the new requirements. The use of eCTD is already...

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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