Presented by
Management Forum
The Common Technical Document (CTD) Submission in the MENA Region Training Course
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.
10 July 2024
+ 28 November 2024 »
from £549
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
- Pharmaceutical Regulatory Affairs in Africa
- Pharmaceutical Regulatory Affairs in Asia
- Pharmaceutical Regulatory Affairs in China
- Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
- Pharmaceutical Regulatory Affairs in the Middle East
- The Common Technical Document (CTD) Submission in the MENA Region
- US FDA - Understanding Key Factors When Working with the FDA
Overview
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.
Benefits of Attending
- Become more familiar with the regulatory environment and framework in the MENA region
- Understand how to compile effective CTD submissions
- Be aware of the specific requirements that should be considered when submitting registration dossiers in major countries in the MENA region
- Learn the most common deficiencies and inquiries raised by the reviewers
Who Should Attend
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:
- 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
The The Common Technical Document (CTD) Submission in the MENA Region course will cover:
Welcome and Introduction
Overview of the Pharmaceuctical 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 (Labeling, SPC & PIL)
Module 3 - Quality - CMC
- 3.2.S (S-part) and different options for submission
- Data requirements for 3.2.P (P-part)
- 3.2.R regional requirements
Important Considerations for Specific Sections in Module 3
- Analytical procedures
- Analytical method validation
- Impurities
- Stability testing requirements
Summary of Module 3 (Product Overall Summary) and Different Formats of Submitting Module 2
Module 5 - Clinical
- Bioequivalence requirements
eCTD Required Technical Specifications
Regulatory Framework Examples (GCC & Egypt)
- New submissions, variations and renewals
Smilarities 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
10 July 2024
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 14196
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 05 Jun
- 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
28 November 2024
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 14197
- GBP 549 649
- EUR 789 929
- USD 893 1,049
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
* 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.
