Presented by
Management Forum
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.
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 regarding generic submissions.
Attendees will receive a detailed explanation of the specific requirements for documents and studies required in generic submissions, with the most common inquiries raised by reviewers to consider. This in turn will assist in avoiding a long list of inquiries that may delay your registration process.
Similarities and differences between the requirements in MENA regions, USA and EU will be discussed.
This is an excellent opportunity to discuss the complexities involved with an expert in this geographic region.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
This course has been designed for professionals of the pharmaceutical industry who are currently, or planning to become involved in the development of regulatory submissions to MENA regions using CTD/eCTD. The programme is particularly suitable for project team members interested in gaining a practical understanding of regulations, tools, and required submission processes. This includes professionals working in but not limited to:
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:
Please contact us for pricing if you are interested in booking 5 or more delegates
13 March 2025
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
05:00-13:00 New York (UTC-04)
Course code 14588
Until 06 Feb
Not ready to book yet?
for 7 days, no obligation
1 July 2025
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 14822
Until 27 May
Not ready to book yet?
for 7 days, no obligation
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
Until 24 Oct
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.
Portugal
Spain
Sweden
1 day
Typical duration
Pricing from:
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:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: