Prof. Bawazir Pharma Consulting Center

Basics of Drug Regulatory Affairs SFDA System Explained Training 15 September 2025 Riyadh
2025-09-15 09:00 - 16:00 (Europe/Moscow) | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: This training program requires physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3400.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 12 September 2025.

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 15 September 2025 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 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.

KEY TOPICS

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

WHO WILL ATTEND
Professionals working in:

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

Basics of Drug Regulatory Affairs SFDA System Explained
2025-11-03 09:00 - 16:00
Date of training 3 November 2025 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3400.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 1 November 2025.

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 3 November 2025 Riyadh

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate
2025-11-25 09:00 - 2025-11-26 16:00
Date of training 25-26 November 2025 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 24 November 2025.
SAR 5200.00

OVERVIEW
Understanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, and marketing, etc.

Download Brochure Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_25-26 November 2025 Riyadh

Basics of Drug Regulatory Affairs SFDA System Explained
2026-01-19 09:00 - 16:00
Date of training 19 January 2026 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3400.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 18 January 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 19 January 2026 Riyadh

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate
2026-01-20 09:00 - 2026-01-21 16:00
Date of training 20-21 Januaruy 2026 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 18 Januaruy 2025.

SAR 5200.00

OVERVIEW
Understanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, and marketing, etc.

Download Brochure Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_20-21 January_2026 Riyadh

Basics of Drug Regulatory Affairs SFDA System Explained
2026-04-06 09:00 - 16:00
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

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate
2026-04-07 09:00 - 2026-04-08 16:00
Date of training 7-8 April 2026 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 3 April 2026.

SAR 5200.00

OVERVIEW
Understanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, and marketing, etc.

Download Brochure Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_7-8 April_2026 Riyadh

Common Technical Documents (CTD) and (eCTD) preparation
2026-04-09 09:00 - 16:00
Date of training 9 April 2026 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2900.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 7 April 2026.

SAR 2000.00

OVERVIEW
This course will offer insight into the compilation of the eCTDs, share experience and best practices gained during eCTD submissions in the GCC, explain the eCTD review and lifecycle process and the upcoming eCTD requirements.

Download Brochure Common Technical Documents (CTD) and (eCTD) preparation 9_April_2026 Riyadh

Basics of Drug Regulatory Affairs SFDA System Explained
2026-05-11 09:00 - 16:00
Date of training 11 May 2026 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3400.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 9 MAY 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 11 May 2026 Riyadh

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate
2026-05-12 09:00 - 2026-05-13 16:00
Date of training 12-13 May 2026 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 12 May 2026.

SAR 5200.00

OVERVIEW
Understanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, and marketing, etc.

Download Brochure Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_12-13 May_2026 Riyadh

Basics of Drug Regulatory Affairs SFDA System Explained
2026-07-06 09:00 - 16:30
Date of training 6 July 2026 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3400.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 5 July 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 July 2026 Riyadh

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate
2026-07-07 09:00 - 2026-07-08 16:30
Date of training 7-8 July 2026 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 5 July 2026.

SAR 5200.00

OVERVIEW
Understanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, and marketing, etc.
Download Brochure Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_7-8 July_2026 Riyadh

Basics of Drug Regulatory Affairs SFDA System Explained
2026-09-01 09:30 - 16:30
Date of training 1 September 2026 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3400.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 29 August 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 1 september 2026 Riyadh

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate
2026-09-07 09:00 - 2026-09-08 16:30
Date of training 7-8 September 2026 Riyadh Saudi Arabia

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 3 September 2026.

SAR 5200.00

OVERVIEW
Understanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, and marketing, etc.
Download Brochure Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate_7-8 September_2026 Riyadh
