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
Certifications:
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:
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
Module 3 - Quality - CMC (Important Considerations for Specific Sections in Module 3)
Life cycle management (Variations)
Summary of Module 3 (Product Overall Summary) and Different Formats of Submitting Module 2
Module 5 - Clinical
eCTD Required Technical Specifications
Regulatory Framework Examples (GCC & Egypt)
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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