The course, a Thomson Reuters Cortellis Regulatory Online Learning module, describes the Common Technical Document (CTD) and the electronic Common Technical Document (e-CTD). The course introduces learners to the CTD by covering its goals and its impact on drug sponsors. The course explores the structure of the CTD, detailing the content and granularity for each of the five modules. It concludes with a review of the eCTD that covers specifications, scope, implementation, architecture, functional requirements, and checksums.
CTD and E-CTD and the impact on drug sponsors
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Explain the goal of the CTD
- Describe the impact the CTD has had on applicants and sponsors
- Recognise the information contained in each module of the CTD
- Understand the granularity of each CTD module
- Describe the purpose of the eCTD specifications
- Define the scope of the eCTD
- Identify key eCTD implementation dates
- Understand the functional requirements of the eCTD
The course takes an average of one hour to complete.