Pharmaceutical Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form
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Free Trial CoursesOutline:Regulatory Approval and the CTD: This part explains the rationale for the CTD, including information on the ICH and EU, US and Japanese regulatory authorities. It also gives information on full and abridged/abbreviated applications. Use of the CTD: This part explains the format, data requirements and limitations of the CTD, differences between the EU and USA and how to get guidance from the ICH, US, EU and Japanese regulatory authorities. Information is also provided on drug master files, certification of suitability, formatting and updating the dossier. Structure of the CTD: This part explains what should be included in the five courses of the CTD from an EU, US and Australian perspective. Conversion of other Formats to CTD: Two tools are provided to assist with obtaining CTD section codes and headings from the old EU NTA format and US FDA NDA format. | Objectives:Students completing this course should be able to: Describe the structure and format of the CTD and appreciate the rationale for it. Explain how to prepare submissions to regulatory authorities in all countries or regions where the CTD format is mandatory, recommended or accepted. Understand the differences between EU and US requirements and how to get guidance from the ICH and other regulatory authorities. Specify how to convert EU NTA and US FDA NDA formats to CTD section codes and headings. | |
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