Events & Courses

Basics of Drug Regulatory Affairs SFDA System Explained

Venue

  • Bawazir Pharma Office
    PJW5+79, Riyadh, 13513, Saudi Arabia
  • Phone
    +966500121286

Details

  • Start: 6 April، 2026 9:00 am - 4:00 pm
  • End: 6 April، 2026 9:00 am - 4:00 pm
Book Your Seat

Overview

Date of training 6 April 2026 Riyadh Saudi Arabia

FEES SAUDI RIYAL
REGISTRATION FEES SAR 3400.00
EARLY BIRD REGISTRATION FEE

PAY YOUR FEE BEFORE  3  April 2026.

SAR 2400.00

OVERVIEW

Understanding drug regulatory affairs is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working in the regulatory affairs departments or related fields, who need knowledge of the SFDA regulatory processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, project management and marketing, etc.

Download Brochure Basics of Drug Regulatory Affairs SFDA Explained 6 April 2026 Riyadh

Learning Objectives
  • Define the key principles and processes used by the Saudi Food and Drug Authority (SFDA) in regulatory submission and approval.
  • Define official regulatory policies and other issues pertinent to a successful SFDA regulatory strategy.
  • Describe key differences between National and the Gulf Cooperation Council Drug Registration regulatory requirements.
  • Describe the requirements for marketing applications for drugs and biologics, New Drug Application (NDA), Biosimilares, Generic drugs, herbal and health products and document preparation.
  • Recognize SFDA oversight and processes during the post-approval phase.
  • Interact appropriately with the SFDA during all phases of drug registration
  • Understand the regulatory requirements for prescription drug labelling and advertising/promotion.
  • Principals of Regulatory Affairs (RA) and Legal Framework
  • SFDA overview and pharmaceutical institutions licensing
  • Principles of Products licensing and Evaluation
  • GMP Inspection and Products Pricing
  • Overview of the pharmacovigilance system
  • Principles of Products Classifications and Listing
  • Products Import, Release and Advertising
  • Overview of the SFDA Electronic systems

Professionals working in:

  • Pharma Regulatory Affairs
  • Fresh Graduate
  • Scientific Office Managers
  • Regulatory Authorities.
  • Dossier Management
  • Pharmacist
  • Compliance

What will you be able to do after the course?

  • Define the key principles and processes used by the Saudi Food and Drug Authority (SFDA) in regulatory submission and approval.
  • Define official regulatory policies and other issues pertinent to a successful SFDA regulatory strategy.
  • Describe key differences between National and the Gulf Cooperation Council Drug Registration regulatory requirements.
  • Describe the requirements for marketing applications for drugs and biologics, New Drug Application (NDA), Biosimilares, Generic drugs, herbal and health products and document preparation.
  • Recognize SFDA oversight and processes during the post-approval phase.
  • Interact appropriately with the SFDA during all phases of drug registration
  • Understand the regulatory requirements for prescription drug labelling and advertising/promotion.
Book Your Seat

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