Master Pharmaceutical products Registration in Qatar

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About Course

Master Manufacturing Site Registration Course The Master Manufacturing Site Registration Course is a practical regulatory affairs course that provides essential knowledge of manufacturing site registration for pharmaceutical products and medical devices. Since site registration is a key requirement for product registration with health authorities, this course helps professionals understand the full process of preparing and submitting a complete site registration dossier. The course covers the core steps of site registration, including site submission letters, dossiers, checklists, application forms, SMP validation, site audits, CAPA, renewal, and the latest regulatory updates. It also highlights an important regulatory change: parallel registration is no longer applicable. Designed based on real industry practice, this course is ideal for professionals who want to strengthen their expertise in regulatory affairs, pharmaceutical registration, medical device registration, and health authority submissions.

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What Will You Learn?

  • Introduction to Qatar’s pharmaceutical regulatory framework
  • Step-by-step drug submission process
  • eCTD preparation, Module 1, and electronic submission guidance
  • Analysis requirements and documentation best practices
  • Barcoding, tracking, and tracing for imports
  • Customs clearance and 2DMatrix implementation
  • Pharmacovigilance and after-sales safety compliance

Course Content

Module 1: Introduction
In this section we will take off towards mastering pharmaceutical products registration with Qatar, we will start by building up our backbone, our trunk, which is the manufacturing site that we will add our branches later on, which are the pharmaceutical products

  • Introduction
    17:36

Module 2: General guidelines
In this section we will be introduced to the general guidelines for products submission, CTD/eCTD transition, with general tips to be consider that we will master it together

Module 3: Product registration
In this section we will practice the actual pharmaceutical product registration, will practice CTD/eCTD transition, and preparation

Module 4: Core CTD/eCTD
In this section, we will build together the CTD/eCTD structure, module by module, the core for such a pharmaceutical product submission

Module 5: eCTD Guidance
In this section we will sail together into the eCTD guidance issued by Qatar MOH

Module 6: eCTD Guidance 2
In this section we will continue with the eCTD guidance

Module 7: Actual eCTD submission
In this section we will practice the actual eCTD submission, going through the appendices and fill it up together to prepare the full actual dossier for submission 

Module 8: Analysis
In this section we will close our submission with exploring the samples analysis conditions, and documents that need to be sent along

Module 9: eCTD Renewal Guidelines
In this section we will clot the eCTD submission with the renewal and its conditions and documents requirements

Module 10: Actual Forms
In this section we will practice together the actual submission forms

Module 11: Bare coding
In this section we will practice one of the most important aspects for pharmaceutical products, the bare-coding, tender application and delivery conditions of Hamad Medical Institution

Module 12: Closing
In this section, we will end up our journey of pharmaceutical products registered with the state of Qatar, by continuing the bare- coding, shipping,

Module 13: Updated Pricing Guidelines
Be the strategic business development, decide about the pricing, set it as competitive ad be ready to penetrate the market successfully and smoothly

Module 14: Updated Circulars for Updated Requirements
Updated Circulars for Updated Requirements

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