CTD NeeS eCTD compilation & submission of registration files

🚑 Embark on a Journey to Mastering Pharmaceutical Manufacturing with CTD, NeeS & eCTD Compilation and Submission!

Course Title: CTD NeeS eCTD Compilation & Submission of Registration Files

Are you ready to navigate the complex world of pharmaceutical regulatory submissions? Our comprehensive online course, led by the expert instructor Asmaa Khalil El-Kersh, is designed to guide you through the intricacies of CTD (Common Technical Documents), NeeS (New Emerging Electronic Submissions), and eCTD (electronic Common Technical Document) processes.

Why This Course?

📚 Understanding the Foundation: CTD is the globally accepted format for regulatory submissions, ensuring that pharmaceutical products meet international standards. The course begins by establishing the rationale behind CTD, NeeS & eCTD, detailing their structure and format, which are essential for successful pharmaceutical registration across MENA and global authorities.

🌟 Global Compliance: With several MENA authorities already implementing eCTD/NeeS or CTD, and many global authorities adopting the CTD submission guidelines, this course is your key to ensuring your pharmaceutical products are compliant with international registration standards.

📈 Market Expansion: By understanding the unified global registration system, you can expand your company's reach into new markets, promoting growth within the pharmaceutical industry and fostering investment opportunities.

Course Objectives:

• Submission Readiness: Learn to prepare submissions that meet the requirements of regulatory authorities worldwide, whether CTD, NeeS, or eCTD formats are mandatory, recommended, or accepted.

• Distinct Understanding: Grasp the differences between CTD, NeeS, and eCTD to effectively manage your pharmaceutical/biological registration files.

Course Outline:

1. Role of Regulatory Affairs: Discover how regulatory affairs shape the pharmaceutical industry and ensure product safety and compliance.

2. Definition and Difference Between CTD, NeeS & eCTD: A clear explanation to differentiate these submission formats and understand their specific applications.

3. CTD/eCTD History: Trace the evolution of these documents from their inception to their current status as critical components of pharmaceutical registration processes.

4. Organization of CTD: Delve into the detailed structure of CTD, focusing on Modules 1, 2, 3, 4, and 5.

5. Criteria of Dossier Preparation: Learn the critical criteria for preparing a dossier that meets all regulatory requirements and standards.

"This course is exclusively taught in Arabic, ensuring you receive expert instruction tailored to your language proficiency."

Embark on this transformative learning experience with Asmaa Khalil El-Kersh as your guide. Enroll now to master the art of CTD, NeeS & eCTD compilation and submission, paving the way for your pharmaceutical products' global success! 🚀💊✨