learning material module 2 HCR577
learning material module 2 HCR577
Overview
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided into five main modules: Module 1 – Administrative information and prescribing information; Module 2 – Overviews and summaries of Modules 3–5; Module 3 – Quality (pharmaceutical documentation); Module 4: Non-clinical reports (pharmacology/toxicology); Module 5: Clinical study reports (clinical trials). Detailed guidelines are provided describing the content of each module and the majority of submissions must now follow the CTD format for submission dossiers. Reference: https://www.researchgate.net/
Learning Objectives
By the end of this module, students will be able to:
- Integrate documents, data, and reports required in modules 2, 3, 4 and 5 of the Common Technical Document (CTD).
- Compile the global modules of the CTD for marketing approval.
- Compare and contrast the new medical product regulations between the United States (U.S.) and the European Union (EU).
- Evaluate ICH guidelines as they apply to the formatting and submission of the CTD.
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