Presented by
Management Forum
Mastering CTD Submissions in the MENA Region Training Course
Comprehensive MENA coverage with key insights from KSA, Egypt, and UAE
This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.
★★★★★ "The objective was to gain an understanding of the regulatory area within the MENA regulatory domain,... more"
28 November 2025
+ 19 May 2026, 27 November 2026 »
from £649
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
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.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of attending
- Become more familiar with the regulatory environment and framework in the MENA region, giving you the confidence to navigate regional requirements with ease
- Understand how to compile effective CTD submissions that meet technical and regulatory expectations
- Be aware of the specific requirements to consider when submitting registration dossiers in key MENA countries, helping to streamline your submission strategy
- Learn the most common deficiencies and inquiries raised by reviewers, so you can avoid delays and strengthen the quality of your submissions
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, but not limited to:
- 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
This course will cover:
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
- Pharmacovigilance requirements
- Product information requirements (Labelling, SPC & PIL)
Module 3 - Quality - CMC (Important Considerations for Specific Sections in Module 3)
- 3.2.S (S-part) and different options for submission
- Data requirements for 3.2.P (P-part)
- 3.2.R regional requirements
- Analytical procedures
- Analytical method validation
- Impurities
- Stability testing requirements
Life cycle management (Variations)
Summary of Module 3 (Product Overall Summary) and Different Formats of Submitting Module 2
Module 5 - Clinical
- Bioequivalence/Biowaiver requirements
eCTD Required Technical Specifications
Regulatory Framework Examples (Egypt & GCC; Saudi Arabia & UAE as role models)
- New submissions, variations and renewals
Similarities and Differences Between CTD Requirements in MENA Region, USA & EU
Mohammad Fat'hy Elnadi
Independent Pharmaceutical Consultant
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
28 November 2025
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 15106
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 24 Oct
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
19 May 2026
Live online
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 16184
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 14 Apr
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
27 November 2026
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 16582
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 23 Oct
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Reviews of IPI's Mastering CTD Submissions in the MENA Region training course
The objective was to gain an understanding of the regulatory area within the MENA regulatory domain, and the webinar proved to be a valuable source of critical information. The speaker was kind enough to address [all] my queries..
Jul 1 2025
Estefania del Castillo Fernandez 
RA Spec, inke
Jul 1 2025
Speaker was very clear and knowledgeable, delivering a well structured course, with good slides to accompany it. I found it highly valuable and it gave me a good introduction into the MENA region. 5/5.
Jenny Lakin 
Head of Product Registration, Torbay Pharmaceuticals
Spain
- Faes Farma, S.A
- inke
- Italfarmaco S.p.A.
Portugal
- Generis Farmacêutica S.A.
- Owlpharma Consulting, Lda.
United Kingdom
- Rosemont Pharmaceuticals Ltd
- Torbay Pharmaceuticals
Sweden
- Camurus AB
Run Mastering CTD Submissions in the MENA Region Live online for your team
1 day
Typical duration
Pricing from:
- GBP 500
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
