Dublin, April 10, 2026 (GLOBE NEWSWIRE) -- The "Mastering CTD Submissions in the MENA Region (May 19, 2026)" training has been added to ResearchAndMarkets.com's offering.
Unlock a deeper understanding of the technical and regulatory landscape for generic CTD submissions across the MENA region in this focused, one-day course.
Led by a regional expert, this training dives into the specific documentation and study requirements essential for successful submissions. You'll also explore the most common reviewer inquiries, and how to proactively address them to prevent delays in your registration process.
Gain valuable insights into how MENA requirements compare and contrast with those in the USA and EU, helping you align your global regulatory strategies more effectively.
Whether you're new to the region or looking to fine-tune your submission process, this is a unique opportunity to navigate complexities with expert guidance and improve your chances of a smooth, inquiry-free approval.
Who Should Attend:
This course is specifically designed for pharmaceutical industry professionals who are currently involved in, or planning to engage with, the development of regulatory submissions to MENA regions using CTD/eCTD formats.
It is particularly well-suited to project team members seeking a practical understanding of regional regulations, essential tools, and submission processes.
Ideal for professionals working in
- Regulatory Affairs
- Export drug regulatory affairs
- R&D
- Documentation Teams
- Quality Control
- Quality Assurance
- Anyone interested in understanding the regulatory environment and requirements in MENA region
Key Topics Covered:
- Overview of the Pharmaceutical Market in the MENA Region
- Format Used by Different MENA Countries (Traditional Registration Dossiers, CTC or eCTD)
- Module 1 - Regional Requirements
- Module 3 - Quality - CMC (Important Considerations for Specific Sections in Module 3)
- Life cycle management (Variations)
- Summary of Module 3 (Product Overall Summary) and Different Formats of Submitting Module 2
- Module 5 - Clinical
- eCTD Required Technical Specifications
- Regulatory Framework Examples (Egypt & GCC; Saudi Arabia & UAE as role models)
- Similarities and Differences Between CTD Requirements in MENA Region, USA & EU
For more information about this training visit https://www.researchandmarkets.com/r/ktg4h6
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
