Common Technical Documents in the Pharmaceutical Industry
About Course
Explore the comprehensive course on the Common Technical Document (CTD) offered by Pharmastate Academy, designed to equip pharmaceutical professionals with essential skills for regulatory submissions worldwide.
This course covers the CTD’s five-module structure, detailing its role in organizing data on drug quality, safety, and efficacy. Designed to streamline the approval process, the CTD ensures regulatory compliance across different regions, facilitating faster and more efficient reviews by authorities. Learners will explore the historical development of the CTD, its application in marketing authorizations, and the transition to electronic submissions (eCTD). The course highlights the importance of adhering to CTD guidelines to avoid delays or rejections and emphasizes best practices for effective document preparation. Suitable for professionals involved in regulatory affairs, this course equips participants with the knowledge to navigate and leverage the CTD framework, ensuring successful submissions and expedited approvals in the global pharmaceutical market.
Enroll in our course to master the intricacies of CTD and enhance your regulatory submission expertise.
Course Content
1. Common Technical Docuin the Pharmaceutical Industryments
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1.1 Introduction
04:43 -
1.2 Introduction
04:54 -
Quiz: Introduction
2. Module 1: Administrative Information
3. Module 2: CTD Summaries
4. Module 3: Quality
5. Module 4: Non-Clinical Study Reports
6. Module 5: Clinical Study Reports
7. eCTD Fundamentals
8. Challenges in CTD Implementation
9. Best Practices
10. ACTD Fundamentals
11. Final Assessment
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