Register healthcare products centrally in the GCC by SFDA

Course Title: Register Healthcare Products Centrally in the GCC by SFDA 🚀

Headline: Master Central Registration with GHC: Streamlining Your Market Entry Across the META Region! 🌐⚗️

Course Description:

Are you ready to revolutionize your approach to healthcare product registration in the Gulf Cooperation Council (GCC)? With the introduction of central registration by the Saudi Food and Drug Authority (SFDA) and its impending expansion to medical devices, staying ahead of regulatory changes is more crucial than ever. This comprehensive course is designed for regulatory affairs professionals who aim to navigate the complex landscape of pharmaceutical regulations in the META region with precision and efficiency.

Why Enroll in This Course?

• Efficiency Revolutionized: Learn how central registration through the Gulf Health Council (GHC) can save you significant time and resources by allowing a single submission for your product to be approved across all GCC countries. ⏱️

• Regulatory Updates: Keep abreast of the latest regulatory developments within the META region, ensuring your company complies with current standards. 📚

• Time-Saving Protocols: Discover how to streamline your application process, reducing the time from submission to approval from over a year to just two months for healthcare products. ✍️

• Future Proofing: Anticipate the upcoming changes that will eliminate the need for individual submissions to each country post-central registration submission. 🔮

• Mandatory Compliance: Understand why central registration is not just a preference but a mandatory requirement for accessing lucrative tenders in the GCC region, which are critical for achieving potential ROI. 🏦

Course Curriculum Overview:

• Introduction to Gulf Central Committee For Drug Registration

• Deep Dive into the Centralized Registration Process for Human Drugs (Module 3)

• Company (Site/MAH) Centralized Registration: A Step-by-Step Guide

• Navigating GCC Guidelines:

  • Renewal of Marketing Authorizations

  • Variation Requirements

  • Presenting the SPC, PIL, and Labeling Information

  • Stability Testing of Active Pharmaceutical Ingredients (API) and Finished Products (FPS)

  • Storage and Transport of Time and Temperature-Sensitive Pharmaceutical Products

• Final Steps: Central Site Audit

By the end of this course, you will have a thorough understanding of the central registration process, the necessary guidelines for compliance, and the tools to successfully navigate the GCC market. 🌍

Join Us on This Journey!

Embark on a learning expedition that will equip you with the knowledge and skills to master central registration in the GCC. Whether you're new to the field or looking to solidify your existing expertise, this course is your gateway to success in the pharmaceutical industry. 🎓🎉

Don't miss out on the opportunity to transform your regulatory career with our expert-led course on central registration. Enroll now and take the first step towards a more efficient and compliant future in healthcare product registration! 🌟