Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center
| FEES | SAUDI RIYAL |
| REGISTRATION FEES |
SAR 1500.00 |
| EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 31 January 2023. |
SAR 1000.00 |
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.
Download Brochure Health and Herbal Products Development Process, and Regulatory Approval 1 February 2023, Riyadh
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