eCTD Training
eCTD training from the team that holds EMA R2 and R3 validation — using the same software we use for real submissions.
Training on eCTD Radar — EMA R2 and R3 validated.
EMCO Egypt's eCTD training programme teaches regulatory affairs professionals to build, validate, and submit electronic Common Technical Document (eCTD) dossiers for Egyptian EDA, Gulf (SFDA, MOH/DHA, GCC), and European (EMA) authorities.
Training uses eCTD Radar — EMCO Egypt's in-house dossier software, validated by EMA at both R2 and R3 — so participants learn on the same tools used for real submissions. When our eCTD trainer demonstrates dossier compilation, they use the software that built our EMA-validated submissions. That is not a course. That is a knowledge transfer.
Available: Arabic and English · In-person and online · Corporate on-site
What the training covers
- What eCTD is and why EDA now requires it for an expanding range of submissions
- eCTD v4 vs v3.2 — differences, which authorities require which version, and how to navigate both
- The five-module CTD structure: Modules 1–5, folder conventions, file naming
- The XML backbone: what it is, how it is generated, and why validity is non-negotiable
- eCTD lifecycle management: initial applications, variations, renewals, and sequence planning
- Authority-specific requirements: SFDA (Saudi Arabia), EDA (Egypt), EMA (Europe), GCC MRP
- Hands-on dossier building with eCTD Radar — project setup, module structure, XML generation, validation
- The 10 most common eCTD validation errors in Gulf submissions and how to prevent them
Format: 2 days | Arabic and English | Hands-on with eCTD Radar
Certificate & Format
Participants receive a completion certificate from EMCO Egypt on finishing the programme. For corporate on-site programmes, training is customised to your actual product dossier types, target authorities, and team competency level. Minimum two weeks' lead time for on-site bookings.