Overview
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.
CPD Hours: 6
Course Content
- Day 1
- 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
Speakers
Mohammad Fat'hy Elnadi
Mohammad has a unique blend of both technical and regulatory experience and qualifications gained from his more than 18 years of experience in the pharmaceutical industry. After graduating in pharmaceutical science from the University of Cairo, he has held posts in the fields of R&D and production of pharmaceutical dosage forms, and as a contract manufacturing coordinator. After completing a postgraduate certificate in management from the American University in Cairo (AUC), he has held senior management roles in business development in the pharmaceutical industry, including opening new markets in local and export markets, which allowed him to deal with different regulatory health authorities and business environments.
He successfully led his team in cooperation with colleagues from other departments within various companies in numerous market access projects in many African countries, ASEAN, GCC and other Middle East Countries.
He has also been responsible for the establishment of supply chain departments in many pharmaceutical companies. Leading planning, local and foreign purchasing, and warehouse functions.
Mohammad is now a regulatory consultant for many pharmaceutical companies. He is an international speaker, providing courses and webinars worldwide in regulatory affairs and supply chain topics related to the pharmaceutical industry.
