Master Drug registration Saudi Arabia

🚑 Master Pharmaceuticals Registration in KSA: Your Gateway to the GCC Market Leader

Course Overview:

🎓 About the Course: This comprehensive course is designed for professionals and managers in the pharmaceutical industry, aiming to conquer the Kingdom of Saudi Arabia (KSA) market – the largest and most influential in the Gulf Cooperation Council (GCC) region. It provides a deep dive into the intricacies of pharmaceutical products registration, ensuring you gain the knowledge, skills, and practical experience necessary for success in this dynamic field.

Key Learning Outcomes:

• Mastery of Pharmaceutical Registration: Become an expert in registering, renewing, and managing variations of pharmaceutical products in KSA.
• Classification Dilemmas: Navigate the complexities of product classification between the COO and SFDA, addressing the critical issues that have arisen over the past five years.
• eSDR System Proficiency: Understand the workflow within the Saudi Food and Drug Authority (SFDA) and the electronic Submission and Review (eSDR) system.
• eCTD Exploration: Dive into the specifics of the electronic Common Technical Document (eCTD), including its structure, modules, checklists, and preparation of forms and templates, with a focus on module 1 for SFDA submissions.
• Regulatory Updates: Stay current with the latest SFDA submission regulations and drug application processes.
• Pathways to Registration: Learn about the Abridged and Verification pathways, which offer streamlined routes for product registration in KSA.
• SMPC & PIL Preparation: Master the preparation of Summary of Product Characteristics (SMPC) and Patient Information Leaflet (PIL) using the latest versions, templates, and SFDA-approved layouts acceptable across the GCC.
• Registration Fees & Final Certificate: Understand the process for payment of registration fees and the importance of maintaining a valid registration certificate through renewals and variations.
• Tracking/Tracing System: Grasp the shift from linear barcodes to 2D Matrix barcodes and the new system set by the SFD for product Aggregation, a topic soon to be adopted across the GCC, with the UAE already leading the way.
• Clearance System & PV Requirements: Conclude your journey by learning about the Integrated Border Management System (IBMRS) and the pharmaceutical vigilance (PV) requirements in KSA.

Course Structure:

1. Introduction to the KSA Pharma Market:

   • Understanding the market significance and potential for ROI.

2. Classification Challenges:

   • Addressing mismatches between COO and SFDA.

3. eSDR & eCTD Navigation:

   • Learning the intricacies of the Saudi electronic submission system and document preparation.

4. Regulatory Insights:

   • Keeping up-to-date with current SFDA regulations.

5. Streamlined Registration Pathways:

   • Exploring the Abridged and Verification pathways for efficient product registration.

6. SMPC & PIL Excellence:

   • Preparing documents in line with the latest guidelines and SFDA layouts.

7. Financial Aspects:

   • Understanding registration fees and maintenance through renewals and variations.

8. Tracking/Tracing and Aggregation:

   • Transitioning to advanced tracking methods and understanding the new SFD requirements.

9. Final Steps:

   • Completing the registration process with a valid certificate and adhering to PV obligations.

Your Success Journey:

Embark on this transformative learning experience to master pharmaceutical product registration in KSA, the cornerstone of the GCC market. This course is your stepping stone to success, ensuring you are well-equipped to navigate and excel within one of the world's most significant pharmaceutical arenas. 🚀

Let's unlock the potential of the KSA pharmaceutical market together! Enroll now and take the first step towards your future in this exciting industry. 📚💼✨