Electronic Common Technical Document (eCTD)
(เอกสารทางเทคนิคทั่วไปอิเล็กทรอนิกส์ (eCTD))
Definition
Electronic Common Technical Document (eCTD) (เอกสารทางเทคนิคทั่วไปอิเล็กทรอนิกส์ (eCTD)) Hard Skill
eCTD is a standardized format for submitting regulatory information electronically to health authorities, facilitating efficient review and lifecycle management of pharmaceutical product information.
Expertise Level
Level 1
Basic
1. Understands the purpose and basic structure of the eCTD format.
2. Can navigate eCTD electronic dossiers with guidance.
3. Familiar with standard submission components and terminology.
Level 2
Intermediate
1. Can compile and organize regulatory documents according to eCTD specifications.
2. Applies validation tools to check eCTD submission compliance.
3. Able to prepare cross-references and lifecycle management within the eCTD framework.
Level 3
Advanced
1. Leads the development and maintenance of eCTD dossiers ensuring global regulatory compliance.
2. Designs strategies for efficient lifecycle management and submission across multiple regions.
3. Troubleshoots complex eCTD validation errors and implements corrective actions.
