The Common Technical Document (CTD) Submission 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.
Upcoming start dates
Suitability - Who should attend?
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
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