New Online Course Offers Practical CTD Submission Training for MENA Region - July 1, 2025

Join this one-day course for a comprehensive dive into the technical and regulatory aspects of CTD submissions in the MENA region for generics. Learn to navigate regional nuances, compare with USA & EU standards, and avoid common reviewer inquiries. Enhance your proficiency and earn CPD certification.

Dublin, June 25, 2025 (GLOBE NEWSWIRE) -- The "Common Technical Document (CTD) Submission in the MENA Region Training Course (ONLINE EVENT: July 1, 2025)" has been added to ResearchAndMarkets.com's offering.

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.

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

Certifications:

  • CPD: 6 hours for your records
  • Certificate of completion

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

Course Agenda:

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 (Labeling, 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 requirements

eCTD Required Technical Specifications

Regulatory Framework Examples (GCC & Egypt)

  • New submissions, variations and renewals

Similarities and Differences Between CTD Requirements in MENA Region, USA & EU

For more information about this training visit https://www.researchandmarkets.com/r/3048se

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