eCTD Submission Certification Program - Part Time/Distance learning
Certificate
Online
Description
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Type
Certificate
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Methodology
Online
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Duration
4 Months
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Start date
Different dates available
Many countries have started adopting the eCTD standard and are accepting eCTD submission. EMEA has started accepting eCTD Submission for all centralized procedure from 1st January 2010 as a step to mandate eCTD submission, paper submission for centralized procedure are no longer accepted.
The Course guides through various aspects of eCTD giving a complete understanding of what eCTD is and how companies can move from paper base to eCTD. The Program focuses on European and US eCTD Submission and help participants compile and submits and eCTD application. The Course is designed for students and Pharma professionals who have no or little knowledge in regards to eCTD and its submission.
Facilities
Location
Start date
Start date
About this course
3 Months Distance learning Program.
Life Science Graduates, Regulatory Affairs freshers and professional
Video Lecture + Practical Exposure
Reviews
Subjects
- QC/QA Managers & Staff
- Documentation Department
- Research Chemist
- Quality Control Chemist
- Distance Learning
- Regulation
- Pharmacy
- Marketing Authorization
- Regulatory Affairs Professionals
- Regulatory Affairs Associates
Teachers and trainers (1)
Global Institute of Regulatory Affairs
Drug Regulatory Affairs
Course programme
- Introduction & Overview of CTD
- CTD Fundamentals ( Module 1 - 5)
- eCTD Fundamentals & Details
- Best Practice in Preparing eCTD
- Submission using eCTD Format
- Life Cycle Management for eCTD
- eCTD Software for Compilation & Validation
- Key Point for Successful eCTD Submission
- 2 Days hands on TRAINING on eCTD Software
eCTD Submission Certification Program - Part Time/Distance learning