OVERVIEW

Understanding drug regulatory affairs in the GCC region 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 and GCC  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.

LEARNING OBJECTIVES

At the conclusion of this training, participants will be able to:

• 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 and GCC regulatory strategy
• Describe the requirements for marketing applications for

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

KEY TOPICS

• Principals of Regulatory Affairs (RA) and Legal Framework
• Principles of Products licensing and Evaluation
• Data requirements for health and herbal products
• Overview of the SFDA Electronic systems

WHO WILL ATTEND

Professionals working in:

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