Who Should Attend
This course is designed for personnel in the pharmaceutical and biotechnology industries involved in the preparation and review of marketing applications for submission to regulatory agencies. This includes regulatory affairs staff, medical and scientific writers, personnel responsible for assembling and collating documentation, as well as, managers and supervisors of departments responsible for generating and approving these documents. These departments include, but are not limited to:
- Chemistry, Manufacturing, and Control Department
- Nonclinical Pharmacology, Pharmacokinetic, and Toxicology Departments
- Clinical and Medical Research
- Quality Control and Quality Assurance
- IT and other personnel involved in eCTD development
- Project Management
Learning Objectives
Upon completing this course, participants will have an understanding of how to plan and prepare all sections of a marketing application in the CTD (Common Technical Document) format per ICH guidance (including starting at the IND stage with a knowledge of the ICH and relevant regional guidances). Participants will also learn tips on how to plan, author, review, and format CTD and eCTD submissions effectively and efficiently, as well as, how to work with submission teams in a classic or virtual development setting.
Course Description
The guidance on marketing applications for drugs and biologics, known as the Common Technical Document (CTD), was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is mandatory for paper-based marketing applications in Europe, Japan, Canada, and other regions, and is highly recommended by FDA.
The eCTD format has become mandatory in key regions for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use the eCTD format. Since January 2008 FDA CDER has required all electronic submissions be in the eCTD format. FDA CBER requires the eCTD format for priority review and rolling submissions. This course will not only address the content and format of each module and sub-sections of the CTD, but will also demonstrate how the CTD/eCTD can be built throughout development starting with the IND.
This course is designed to identify and review applicable regulatory guidelines (U.S., EU, ICH, and other regional guidances), providing information on the content and preparation of the CTD, and will address specifications and granularity for electronic submissions (eCTD). The course discusses tips for efficient preparation of the CTD with submission-ready reports that can be written early in development and inserted or expanded for marketing applications. The use of CTD mapping and templates to facilitate gap analysis, project management, CMC strategy, and life cycle management will also be discussed in interactive sessions. Case studies will be presented throughout the course to encourage discussions.
View Course Agenda
Past Participant's Comments:
"Very thorough presentation. Excellent handouts"
Donna B., Director Medical Writing, Sepracor
"This course was excellent! The Course Director did a nice job of presenting all the material."
Michele C., Senior Regulatory Assoc., Par Pharmaceuticals
"The Instructor covered a great deal of material in two days and was very knowledgeable on many aspects of FDA Inspections. I would recommend this course to my colleagues."
David M., Director, Bayer
“The Course Director had a wealth of knowledge to share along with a good deal of practical experience.”
Data Management, Merck
“Course content was excellent! It provided a fundamental understanding of the regulatory process.”
Tara M., Regulatory & Compliance Supervisor, Wyeth
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