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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

Need help?  Enrol or reserve

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

Enrol or reserve

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

Enrol or reserve

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.

More details

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

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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

View basket 

 
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.

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:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy