Prof. Bawazir Pharma Consulting Center

Basics of Drug Regulatory Affairs SFDA System Explained Training 10 January, 2022 Riyadh
2022-01-10 09:00 - 17:00 (Europe/Moscow) | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training programs require physical present 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 07 January 2022.
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 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 10_January_2022 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 23-24 November, 2021 Riyadh
2021-11-23 09:00 - 2021-11-24 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training program require physical presnt and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 4500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 19 November, 2021.
SAR 3500.00

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 23-24 2021 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 17 November, 2021 Riyadh
2021-11-17 09:00 - 17:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training program require physical presnt 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 12 November 2021.
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 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 17_November_2021 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

CTD Quality Module 3 for new chemical and Generic products Chemistry, Manufacturing and Control (CMC) 26 October, 2021 Riyadh
2021-10-26 09:00 - 17:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training program require physical presnt and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 23 October, 2021.
SAR 1500.00

OVERVIEW
The Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected, and the formulation proposed are suitable for the intended use.
This module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development, a regulatory submission and the on-going marketing and life cycle management of a medicinal product.
As drug development of the dosage form moves from concept to commercialization, the breadth and depth of CMC documentation required in submissions increases in parallel.
Download Brochure CTD Quality Module 3 for new chemical and Generic products Chemistry, Manufacturing and Control (CMC) 26 October, 2021 Riyadh

LEARNING OBJECTIVES
• Define the different types of data requirements for type of product
• Describe the general CMC requirements for New Drug Application
• Distinguish CMC information required for special categories
• Understand the Substance part of the Module
• Identify the required information for product part of the module
• Understand how to respond to regulatory authority questions.
KEY TOPICS

The CMC aspects of the regulatory submission will cover
Characterization of the active substance
Raw materials used to manufacture the active substance and finished dosage form
Description of the product and process development
Description of the manufacturing processes
Release and stability testing data for both the active substance and the dosage form
Analytical methods and specifications used for testing and release of raw materials
Container and closure systems

WHO WILL ATTEND
Professionals working in:

Regulatory Affairs staff
Scientific office staff
Production manager
QA Manger
QC Manager.

Advance Pharmacovigilance 19-20 October, 2021 Riyadh, Saudi Arabia
2021-10-19 09:00 - 2021-10-20 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training program require physical presnt and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 4500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 17 October, 2021.
SAR 3500.00

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 Pharmacovigilance 19-20 October, 2021 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

Basics of Drug Regulatory Affairs SFDA System Explained Training 12 October, 2021 Riyadh
2021-10-12 09:00 - 17:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
Note: All training program require physical presnt 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 10 October 2021.
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 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_October_2021 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

Pharmaceuticals Pricing, Reimbursement and Market Access. SFDA System Explained 14 September, 2021 Riyadh
2021-09-14 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 10 September 2021.
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 Pharmaceuticals Pricing SFDA System Explained 14 September, 2021 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.

Basics of Drug Regulatory Affairs SFDA System Explained Training 13 September, 2021 Riyadh
2021-09-13 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 1500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 9 September 2021.
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 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 13_September_2021 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 7-8 Sebtember, 2021 Riyadh
2021-09-07 09:00 - 2021-09-08 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 4500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 03rd September, 2021.
SAR 3500.00

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 7-8 September 2021 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 6-7 July, 2021 Riyadh
2021-07-06 09:00 - 2021-07-07 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 4500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 01st July, 2021.
SAR 3500.00

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 6-7 July 2021 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

Pharmaceuticals Pricing, Reimbursement and Market Access. SFDA System Explained 1 June, 2021 Riyadh
2021-06-01 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 31 May 2021.
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 Pharmaceuticals Pricing, Reimbursement and Market Access. SFDA System Explained 1 June, 2021 Riyadh, Saudi Arabia

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.

Basics of Drug Regulatory Affairs SFDA System Explained Training 31 May, 2021 Riyadh
2021-05-31 09:00 - 17:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 1500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 30 May 2021.
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 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 31_May_2021 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 25-26 May, 2021 Riyadh
2021-05-25 09:00 - 2021-05-26 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 4500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 23th May, 2021.
SAR 3500.00

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 25-26 May 2021 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

Preparing VNeeS Submission 11 April, 2021 Riyadh
2021-04-11 09:00 - 17:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 10 April, 2021.
SAR 1500.00

OVERVIEW
Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant VNees 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 VNees mandates.
Download Brochure Preparing VNeeS Submission 11 April, 2021 Riyadh

LEARNING OBJECTIVES
Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant VNees 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 VNees mandates.
At the conclusion of this course, participants will be able to:

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

KEY TOPICS:

Overview of VNees readiness at the agencies
Impact of the VNees on regulatory processes and procedures
VNees compilation and life cycle management
VNees 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

Advance Pharmacovigilance 05-06 April, 2021 Riyadh, Saudi Arabia
2021-04-05 09:00 - 2021-04-06 17:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 4500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 02nd April, 2021.
SAR 3500.00

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 Pharmacovigilance 05-06 April, 2021 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

Preparing VNeeS Submission 31 March, 2021 Riyadh
2021-03-31 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 29 March, 2021.
SAR 1500.00

OVERVIEW
Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant VNees 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 VNees mandates.
Download Brochure Preparing VNeeS Submission 31 March, 2021 Riyadh

LEARNING OBJECTIVES
Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant VNees 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 VNees mandates.
At the conclusion of this course, participants will be able to:

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

KEY TOPICS:

Overview of VNees readiness at the agencies
Impact of the VNees on regulatory processes and procedures
VNees compilation and life cycle management
VNees 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

Basic of Good Manufacturing Practice (GMP) SFDA Explained 16 March, 2021 Riyadh
2021-03-16 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 1500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 15 March, 2021.
SAR 1000.00

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.

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

Post Approval Activities and Compliance: Variations Guideline 15 March, 2021 Riyadh
2021-03-15 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 1500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 10 March 2021.
SAR 1000.00

OVERVIEW
This course will provide an overview and analysis of the various regulatory activities that take place post-approval: In particular, the current regulatory climate will be discussed in depth and numerous examples will be provided to illustrate effective filing of notification techniques. Common issues which have caused difficulties for pharmaceutical firms will also be discussed. The training will discuss in detail the GCC guideline for variations management and post approval commitment.

LEARNING OBJECTIVES

Describe the role of regulatory affairs on meeting SFDA regulations
Understand the regulatory activities that take place post approval of their products.
Discuss the post approval commitment that must be met.
Understand the post approval commitment and how to help company comply with them

KEY TOPICS

Post-approval commitments
PV
PSUR
RMMs
Variations management

WHO WILL ATTEND
Professionals working in:

Regulatory Affair staff
Scientific office staff
Production manager
QA Manger
QC Manager

SFDA Pharmacovigilance System Explained 09-10 March, 2021 Riyadh
2021-03-09 09:00 - 2021-03-10 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 4500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 08th March, 2021.
SAR 3500.00

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.

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

Pharmaceuticals Pricing SFDA System Explained 3 March, 2021 Riyadh
2021-03-03 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 27th February 2021.
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.

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.

CTD Quality Module 3 For health and herbal products Chemistry Manufacturing and Control (CMC) Of product quality requirements 2 March, 2021 Riyadh
2021-03-02 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 1500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 24th February 2021.
SAR 1000.00

OVERVIEW
The Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected, and the formulation proposed are suitable for the intended use. This module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development, a regulatory submission and the on-going marketing and life cycle management of a medicinal product. As drug development of the dosage form moves from concept to commercialization, the breadth and depth of CMC documentation required in submissions increase in parallel.

LEARNING OBJECTIVES

Define the different types of data requirements for type of product
Describe the general CMC requirements for New Drug Application
Distinguish CMC information required for special categories
Understand the Substance part of the Module
Identify the required information for product part of the module
Understand how to respond to regulatory authority questions.

KEY TOPICS
The CMC aspects of the regulatory submission will cover:

Characterization of the active substance
Raw materials used to manufacture the active substance and finished
dosage form
Description of the product and process development
Description of the manufacturing processes
Release and stability testing data for both the active substance and the dosage form
Analytical methods and specifications used for testing and release of raw materials
Container and closure systems

WHO WILL ATTEND
Professionals working in:

Regulatory Affair staff
Scientific office staff
Production manager
QA Manger
QC Manager

Health and Herbal Products Development Process and Regulatory Approval 1 March 2021 Riyadh
2021-03-01 09:00 - 17:00 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 1000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 24th February 2021.
SAR 800.00

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.

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

Common Technical Documents (CTD) and (eCTD) preparation 24 February, 2021 Riyadh
2021-02-24 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 21 February, 2021.
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.

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

CTD Quality Module 3 for new chemical and Generic products Chemistry, Manufacturing and Control (CMC) 23 February, 2021 Riyadh
2021-02-23 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 2000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 21 February, 2021.
SAR 1500.00

OVERVIEW
The Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected, and the formulation proposed are suitable for the intended use.
This module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development, a regulatory submission and the on-going marketing and life cycle management of a medicinal product.
As drug development of the dosage form moves from concept to commercialization, the breadth and depth of CMC documentation required in submissions increases in parallel.

LEARNING OBJECTIVES
• Define the different types of data requirements for type of product
• Describe the general CMC requirements for New Drug Application
• Distinguish CMC information required for special categories
• Understand the Substance part of the Module
• Identify the required information for product part of the module
• Understand how to respond to regulatory authority questions.
KEY TOPICS

The CMC aspects of the regulatory submission will cover
Characterization of the active substance
Raw materials used to manufacture the active substance and finished dosage form
Description of the product and process development
Description of the manufacturing processes
Release and stability testing data for both the active substance and the dosage form
Analytical methods and specifications used for testing and release of raw materials
Container and closure systems

WHO WILL ATTEND
Professionals working in:

Regulatory Affairs staff
Scientific office staff
Production manager
QA Manger
QC Manager.

Basics of Drug Regulatory Affairs SFDA System Explained Training 22 February, 2021 Riyadh
2021-02-22 09:00 - 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 1500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 21 February 2021.
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 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

SFDA Pharmacovigilance System Explained 15-16 February, 2021 Riyadh
2021-02-15 09:00 - 2021-02-16 17:30 | Bawazir Pharma Office, PJW5+79, Riyadh, 13513, Saudi Arabia
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 4500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 10th February , 2021.
SAR 3500.00

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.

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-29-30 December,2020- Riyadh
2020-12-29 09:00 - 2020-12-30 17:00
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 4500.00

EARLY BIRDS REGISTRATION FEE PAY YOUR FEE BEFORE 28th December, 2020.
SAR 3500.00

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 PV Brochure Riyadh 29-30 December 2020
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 22/12/2020
2020-12-22 09:00 - 17:30
FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 1500.00

EARLY BIRDS REGISTRATION FEE PAY YOUR FEE BEFORE 17th December, 2020.
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 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 Basics of Drug Regulatory Affairs Brochure 22 December 2020
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

09:00 – 10:30 SESSION 1
Principals of Regulatory Affairs (RA) and Legal
Framework

The history and evolution of the regulatory authorities

and profession.

Principles of Regulatory Affairs and regulatory professional
Basic terms and definitions.
Legal Framework for Pharmaceuticals regulations.
SFDA Law.
Pharmaceuticals Institutions and Preparations Law.
Principles of pharmaceutical preparations registrations.
International Council for Harmonization (ICH) guidelines.
Narcotics and psychotropic law.

10:30 – 11:00: COFFEE BREAK
11:00 – 12:30 SESSION 2
Principles of Products licensing and Evaluation

ABC for pharmaceutical products licensing.
Regulatory Framework for Drug Approvals V_5 0.
Guidance for Submission V_4 0.
General requirements for pharmaceuticals preparations registration.
Principles of pharmaceutical preparations registrations.
Common Technical Document (CTD) and eCTD.
Pharmaceutical preparations evaluation process.
Registration Committees.
Product Variations Guidance.

12:30 – 13:30 LUNCH
13:30 – 15:00 SESSION 3
Principles of Products Classifications and Listing

Overview of product classifications.
Guidance for products classifications.
Principles of products listing.
Overview of the SFDA Electronic systems.
