Core Concept of eCTD by Rajashri Ojha, from Raaj GPRAC Private limited
Автор: rajashri ojha
Загружено: 2020-07-19
Просмотров: 1545
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Raaj GPRAC proud to train more than 15000 candidates on CTD-eCTD Regulatory submissions to Europe and USA and more than 40 countries across the Globe.
Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical environment. eCTD is an interface for the pharmaceutical industry to agency transfer of regulatory information. Since June 2003, applicants have had the option of submitting an eCTD in parallel with the paper Common Technical Document, following sign-off by the ICH- eCTD Specification document at Step 4. It is designed to make regulatory submissions easier and more efficient for drug makers and for regulators. When it comes to eCTD submission, there continues to be differences among different countries and even ICH regions. The standardization that electronic submissions will bring will allow for much greater consistency not only for the regulators but also for organizations. It is important that eCTD ready documents are prepared by authoring them in eCTD compliant templates. If this is not undertaken, a large amount of the “publishing time” is spent in document reformatting. As the move from paper-based to eCTD submissions continues around the world, a multitude of challenges are to be faced regulatory departments. This workshop describes eCTD History, Benefits of Implementing, Challenges, Modules, Risks involved in eCTD publishing and Quality Control.
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