Prof. Bawazir Pharma Consulting Center

Understanding Biological Good Manufacturing Practice GMP 22 May 2023 Riyadh
2023-05-22 09:00 - 16:30 (Europe/Moscow) | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 18 May, 2023.

SAR 2000.00

OVERVIEW
Understanding basics of Biological GMP are essential skills for people working in pharmaceutical industry. This course will provide an explanation to biological GMP guidelines and how to prepare for inspection. This training will also enhance understanding and be beneficial to persons who work in scientific offices, regulatory affairs, pharmaceutical manufacturers, data management, basic research, project management and marketing, etc.

Download Brochure Understanding Biological Good Manufacturing Practice (GMP) 22_May_2023

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

Understand the principals of biological manufacturing.
Describe the components for Bio- pharmaceutical industry.
Understand Host systems.
Understand bioreactor systems and bioreactor modes
Understand Bioprocess Engineering
Understand Mammalian bioprocess
Understand Cell Growth Curve and biological data and analysis
Describe Cell banking system

KEY TOPICS

Bio-Pharmaceutical Industry
Quality Management
Personnel
Bioprocess Engineering
Mammalian Bioprocess
Cell Banking System

WHO WILL ATTEND
Professionals working in:

Production manager
QA manager
QC manager
Pharma Regulatory Affairs
Scientific Office Managers
Regulatory Authorities.
Bio & pharmaceutical manufacturers
Pharmacists
Bioprocess team
CRO staff

Basics of Drug Regulatory Affairs SFDA System Explained Training 31 May 2023 Jeddah
2023-05-31 09:00 - 16:30 | Centro Salama Hotel, Centro Salama Al Madinah Al Munwarrah Street Jeddah Saudi Arabia, Jeddah, Makkah, Saudi Arabia
Note: This training require physical presence and will be held in Jeddah

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 10000.00

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 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 regulatory strategy
Describe key differences between National and the Gulf Cooperation Council Drug Registration (GCC_DR) 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.
Recognise 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 Training 12 June, 2023 Riyadh
2023-06-12 09:00 - 16:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 9 June 2023.

SAR 1700.00

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 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 12 June 2023 Riyadh, Saudi Arabia

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 (GCC_DR) 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.
Recognise 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

SFDA Pharmacovigilance System Explained 13-14 June, 2023 Riyadh, Saudi Arabia
2023-06-13 09:00 - 2023-06-14 16:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 5500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 4 June, 2023.
SAR 4500.00

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 SFDA Pharmacovigilance System Explained _13-14_June_2023 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

SFDA Pharmacovigilance System Explained 22-23_August, 2023 Riyadh, Saudi Arabia
2023-08-22 09:00 - 2023-08-23 16:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 18 August, 2023.
SAR 4500.00

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 SFDA Pharmacovigilance System Explained_22-23_Aug_2023 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 19-20_September, 2023 Riyadh, Saudi Arabia
2023-09-19 09:00 - 2023-09-20 16:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 18 September, 2023.
SAR 4500.00

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_19-20_Sept_2023 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

Basics of Drug Regulatory Affairs SFDA System Explained Training 2 October, 2023 Riyadh
2023-10-02 09:00 - 16:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 29 September 2023.

SAR 1700.00

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 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 2 October 2023 Riyadh, Saudi Arabia

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 (GCC_DR) 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.
Recognise 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

Advance Regulatory Understanding SFDA Drug Pricing System, Reimbursement and Market Access. 3 October 2023 Riyadh
2023-10-03 09:00 - 16:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 29 September 2023.

SAR 1500.00

OVERVIEW
The rise in costs of pharmaceutical products in general affects all sectors of the
health care industry, including private insurers and patients. This workshop shall
give an overview on the pricing practices of pharmaceutical products in SFDA and GCC_DR.
In addition, a thorough discussion on the pricing policy by SFDA shall be presented and what you need to learn to price your products.
Download Brochure Advance Regulatory Understanding SFDA Drug Pricing System, Reimbursement and Market Access 3 October 2023 Riyadh

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

Understand the history of pharmaceuticals pricing and the different types of pricing modalities.
Understand the principals of SFDA and GCC_DR pricing system.
How to prepare your product pricing certificate. How to predict your product pricing
How to petition pricing decision.

KEY TOPICS

History of Pharmaceuticals pricing.
Modalities of pricing.
Reference pricing and reimbursement.
Pharmacoeconomic.
Pharmaceutical Pricing Policies – Regional Experience
How to prepare your pricing certificate?
How to predict your product price?

WHO WILL ATTEND

Professionals working in:

Healthcare Executives.
Economists.
Pharmaceutical Industry.
Health Insurance Professionals.
Law professionals.
Pharma Regulatory Affairs.
Scientific Office Managers.
Regulatory Authorities.
pharmaceutical manufacturers.
Pharmacist.

Advance Comprehensive Pharmacovigilance Training 9-10 October 2023 Riyadh, Saudi Arabia
2023-10-09 09:00 - 2023-10-10 16:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 8th October, 2023.
SAR 4000.00

OVERVIEW
This two-day course is designed for those who look to increase their knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to comply with SFDA regulations.
Download Brochure Advance Comprehensive Pharmacovigilance Training 9-10 October 2023 Riyadh, Saudi Arabia

KEY TOPICS

Pharmacoepidemiological methods
Management of PharmacovigilanceData
Spontaneous Case Processing
Literature searching
Pharmacovigilance methods
Signal detection
Causality assessment

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 14-15 November, 2023 Riyadh, Saudi Arabia
2023-11-14 09:00 - 2023-11-15 16:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 12 November, 2023.
SAR 4500.00

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_14-15_November_2023 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

Common Technical Documents (CTD) and (eCTD) preparation 22 November 2023 Riyadh
2023-11-22 09:00 - 16:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 20 November 2023.

SAR 1500.00

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 22_November_2023 Riyadh, Saudi Arabia

LEARNING OBJECTIVES
Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant eCTD submissions. This begins with understanding what will be accepted and what will not. Put yourself and your company a step ahead of competitors by understanding the technical skills and regulatory requirements necessary to meet the impending eCTD mandates.

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

Participate in the preparation of the eCTD including “submission ready documents”
Recognize eCTD requirements on a regional and ICH basis
Create and submit technically valid GCC eCTDs
Prepare to move from a paper to eCTD process
Describe technology used for eCTD compilation, validation and review
Understand the difference between eCTD and NeeS submission
Have an overview on future eSubmission development

KEY TOPICS

Overview of eCTD readiness at the agencies
Impact of the eCTD on regulatory processes and procedures
Practical experience of submitting an eCTD in the GCC
eCTD compilation and life cycle management
eCTD Validation
Document granularity and readiness
Technical issues
Specifications and standards

WHO WILL ATTEND
Professionals working in:

Pharma Regulatory Affairs
Scientific Office Managers
Regulatory Authorities.
Dossier Management
Pharmacist
Compliance
Submission Management/Electronic Publishing
Data Management / IT

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 26-27 December, 2023 Riyadh, Saudi Arabia
2023-12-26 09:00 - 2023-12-27 16:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 24 December, 2023.
SAR 4500.00

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_26-27_December_2023 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

Basics of Drug Regulatory Affairs SFDA System Explained Training 15 January, 2024 Riyadh
2024-01-15 09:00 - 16:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3000.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 11 January 2024.

SAR 1700.00

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 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 January 2024 Riyadh, Saudi Arabia

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 (GCC_DR) 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.
Recognise 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

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 6-7 February 2024 Riyadh, Saudi Arabia
2024-02-06 09:00 - 2024-02-07 16:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 5 February, 2024.
SAR 4500.00

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_6-7_Feb_2024 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

Basics of Drug Regulatory Affairs SFDA System Explained Training 28 February, 2024 Riyadh
2024-02-28 09:00 - 16:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 3000.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 27 February 2024.

SAR 1700.00

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 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 28 February 2024 Riyadh, Saudi Arabia

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 (GCC_DR) 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.
Recognise 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

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 16-17 April 2024 Riyadh, Saudi Arabia
2024-04-16 09:00 - 2024-04-17 16:30 | 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 6000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 15 April, 2024.
SAR 4500.00

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_16-17_April_2024 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

Basics of Drug Regulatory Affairs SFDA System Explained Training 29 April, 2024 Riyadh
2024-04-29 09:00 - 16:00 | 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 3000.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 25 April 2024.

SAR 1700.00

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 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 29 April 2024 Riyadh, Saudi Arabia

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 (GCC_DR) 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.
Recognise 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 Training 3 June 2024 Riyadh
2024-06-03 09:00 - 16:00 | 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 3000.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 31 May 2024.

SAR 1700.00

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 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 June, 2024 Riyadh Saudi

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 (GCC_DR) 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.
Recognise 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

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 4-5 June 2024 Riyadh Saudi Arabia
2024-06-04 09:00 - 2024-06-05 16:30 | 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 6000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 2 June, 2024.
SAR 4500.00

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_4-5_June_2024 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

Online Basic of Good Manufacturing Practice (GMP) SFDA Explained 9 June 2024 Riyadh
2024-06-09 09:00 - 16:30 | Online, Online
Note: Online training program.
Link will be sent one day before the training day

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 4500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 5 June 2024.

SAR 2500.00

OVERVIEW
Understanding basics of GMP are essential skills for people working in pharmaceutical industry. This course will provide an explanation to SFDA GMP guidelines and how to prepare for inspection. This training will also enhance understanding and be beneficial to persons who work in scientific offices, regulatory affairs, pharmaceutical manufacturers, data management, basic research, project management and marketing, etc.

Online
Download Brochure Online Basics of Good Manufacturing Practice (GMP) SFDA Explained 9 June 2024

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

Understand the principals of SFDA GMP guidelines.
Describe the different types of GMP inspection.
Understand The general GMP inspection components

KEY TOPICS

GMP Legal Framework
Type of GMP Inspection
Quality Management
Personnel
Premises and Equipment
Documentation
Production
Quality Control
Contract Manufacture and Analysis
Complaints and Product Recall
Self Inspection

WHO WILL ATTEND
Professionals working in:

Pharma Regulatory Affairs
Fresh Graduate
Scientific Office Managers
Regulatory Authorities.
Pharmaceutical manufacturers
Pharmacist
CRO staff

Common Technical Documents (CTD) and (eCTD) preparation 10 June 2024 Riyadh
2024-06-10 09:00 - 16:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: This training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 9 June 2024.

SAR 1500.00

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 10_June_2024 Riyadh

LEARNING OBJECTIVES
Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant eCTD submissions. This begins with understanding what will be accepted and what will not. Put yourself and your company a step ahead of competitors by understanding the technical skills and regulatory requirements necessary to meet the impending eCTD mandates.

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

Participate in the preparation of the eCTD including “submission ready documents”
Recognize eCTD requirements on a regional and ICH basis
Create and submit technically valid GCC eCTDs
Prepare to move from a paper to eCTD process
Describe technology used for eCTD compilation, validation and review
Understand the difference between eCTD and NeeS submission
Have an overview on future eSubmission development

KEY TOPICS

Overview of eCTD readiness at the agencies
Impact of the eCTD on regulatory processes and procedures
Practical experience of submitting an eCTD in the GCC
eCTD compilation and life cycle management
eCTD Validation
Document granularity and readiness
Technical issues
Specifications and standards

WHO WILL ATTEND
Professionals working in:

Pharma Regulatory Affairs
Scientific Office Managers
Regulatory Authorities.
Dossier Management
Pharmacist
Compliance
Submission Management/Electronic Publishing
Data Management / IT

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 9-10 July 2024 Riyadh Saudi Arabia
2024-07-09 09:00 - 2024-07-10 16:30 | 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 6000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 8 July, 2024.
SAR 4500.00

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_9-10_July_2024 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

Basics of Drug Regulatory Affairs SFDA System Explained Training 15 July 2024 Riyadh
2024-07-15 09:00 - 16:00 | 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 3000.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 12 July 2024.

SAR 1700.00

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 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 July 2024 Riyadh Saudi Arabia

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 (GCC_DR) 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.
Recognise 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 Training 20 August 2024 Riyadh
2024-08-20 09:00 - 16:00 | 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 3000.00

EARLY BIRD REGISTRATION FEE
PAY YOUR FEE BEFORE 17 August 2024.

SAR 1700.00

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 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 20 August 2024 Riyadh Saudi Arabia

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 (GCC_DR) 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.
Recognise 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

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 26-27 August 2024 Riyadh Saudi Arabia
2024-08-26 09:00 - 2024-08-27 16:30 | 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 6000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 22 August 2024.
SAR 4500.00

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_26-27_August_2024 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

Basics of Drug Regulatory Affairs SFDA System Explained Training 21 October 2024 Riyadh
2024-10-21 09:00 - 16:00 | 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 18 October 2024.

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 21 October 2024 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

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 22-23 October 2024 Riyadh Saudi Arabia
2024-10-22 09:00 - 2024-10-23 16:30 | 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 6500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 18 October 2024.
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_22-23_October_2024 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance

Basics of Drug Regulatory Affairs SFDA System Explained Training 9 December 2024 Riyadh
2024-12-09 09:00 - 16:00 | 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 6 December 2024.

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 9 December 2024 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

Advance Comprehensive Pharmacovigilance Training 17-18 December 2024 Riyadh
2024-12-17 09:00 - 2024-12-18 16:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 6500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 16th December, 2024.
SAR 5200.00

OVERVIEW
This two-day course is designed for those who look to increase their knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to comply with SFDA regulations.
Download Brochure Advance Comprehensive Pharmacovigilance Training 17-18 December 2024 Riyadh, Saudi Arabia

KEY TOPICS

Pharmacoepidemiological methods
Management of PharmacovigilanceData
Spontaneous Case Processing
Literature searching
Pharmacovigilance methods
Signal detection
Causality assessment

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist

Comprehensive SFDA Pharmacovigilance System Explained Basic and Intermediate 13-14 January 2025 Riyadh Saudi Arabia
2025-01-13 09:00 - 2025-01-14 16:30 | 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 6500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 11 January 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_13-14 January_2025 Riyadh, Saudi Arabia

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

Define the key principles and processes of pharmacovigilance

Define official regulatory policies and other issues pertinent to SFDA Pharmacovigilance System
Describe the component of the PV System
Understand the role and responsibilities of the QPPV
Understand national pharmacovigilance sub-system file (national PSSF)
Recognize SFDA oversight and processes during the post-approval phase.
Understand ADR case assessment, PSUR and risk management.
Interact appropriately with the SFDA regarding PV
Understand the process of PV inspection and audits.

KEY TOPICS

Introduction to Pharmacoepidemiology and Pharmacovigilance
Pharmacovigilance systems and their quality systems
Pharmacovigilance System Master File
Qualified Person Responsible for Pharmacovigilance in Saudi Arabia
Risk Management Systems
Management and Reporting of Adverse Reactions to Medicinal Products
Periodic Safety Update Reports
Post-Authorization Safety Studies
Signal Management
Safety Communication
Risk Minimization Measures
Pharmacovigilance Inspections
Pharmacovigilance Audits
Basic concepts of vaccines and adverse events following immunization

WHO WILL ATTEND
Professionals working in:

QPPV
Pharma Regulatory Affairs
Country Managers
Scientific Office Managers
Contract Research Organizations (CROs)
Regulatory Authorities.
Pharmacist
Compliance
