CTD_ECTD Training/Workshop Course.
eCTD-CTD training and workshop conduction, including an overview illustrating the relevant portfolio with the advantages and whom should attend this course. This course will be conducted by top qualified Trainers.
CTD “Common Technical Dossier” is the mandatory format for regulatory submissions worldwide. This course explains the rational for the CTD & eCTD. Also, provides detailed guidance on its structure and format. Bimag Solution had implemented CTD as a submission format for pharmaceutical products; Almost Global authorities (Ministry of Health) have implemented CTD submission as standard guidelines for registration of products.
Course Objectives:
Participants completing this course should be able to:
1. Prepare submissions to regulatory authorities in all countries or regions where the CTD format is mandatory, recommended or accepted.
2. Understand the difference between CTD, eCTD.
Course Outline:
1. Role of Regulatory Affairs.
2. Definition and difference between CTD, eCTD.
3. CTD/eCTD History.
4. Organization of CTD (Module 1, 2, 3, 4 & 5)
5. Criteria of dossier preparation.
6. Validation of the software.
Who Should Attend:
* R & D
* Quality Control
* Quality Assurance
* Medical Affairs
* Supply Chain
* IT Personnel
* QPPV & Backup
Advantages of Our Training & Workshop Conducted Course:
1. Organized by Educe USA Granted Approved certification.
2. Workshop including hand on Use (for eCTD software) for two days out of 4 days (Course duration)
3. Empirical live cases ý Conducted by most Efficient Licensed Instructors.
4. Introduce Further Refreshment follow up Session two months after training conduction upon request, free of charge. This is to discuss all matters and practical issues might be faced while practicing eCTD_CTD file preparation, assuring perfection and professionalism with high level prepared CTD dossier.
