Prof. Bawazir Pharma Consulting Center

SFDA Pharmacovigilance System Explained 3-4 January, 2023 Riyadh, Saudi Arabia
2023-01-03 09:00 - 2023-01-04 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 5000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 2 January, 2023.
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 3-4_January_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 28 December, 2022 Riyadh
2022-12-28 09:00 - 16:30
Note: All training programs require physical presence 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 26 December 2022.

SAR 1200.00

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 December 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

Basics of Drug Regulatory Affairs SFDA System Explained Training 14 November, 2022 Riyadh
2022-11-14 09:00 - 16:30
Note: All training programs require physical presence 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 13 November 2022.

SAR 1200.00

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 14_November_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 8-9 November, 2022 Riyadh, Saudi Arabia
2022-11-08 09:00 - 2022-11-09 16:30
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 5000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 6 November, 2022.
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 8-9_November_2022 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

Post Approval Activities and Compliance: Variations Guideline 8 November, 2022 Riyadh
2022-11-08 09:00 - 16:30
Note: All training programs require physical presence 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 21 October 2022.

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.

Download Brochure Post Approval Activities and Compliance_Variations Guideline 8_November_2022

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

Advance GMP II Sterile Medicinal Products 3 November, 2022 Riyadh
2022-11-03 09:00 - 16:30
Note: All training programs require physical presence 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 2 November, 2022.

SAR 1000.00

OVERVIEW
Understanding the Pharmaceutical Quality System is an essential skills for people working in pharmaceutical manufacturing industry. This course will provide an overview of the pharmaceutical quality system for sterile medicinal product as specified in SFDA GMP guidelines and prepare for implementation. This one day course is designed to increase their knowledge in contamination control strategy, specific technologies and will provide a comprehensive, yet practical assessment of the regulations.
This training will also enhance understanding and beneficial to persons who work in product development and Technology transfer, regulatory compliance, pharmaceutical manufacturers, production engineering, site engineering, Quality Operations etc.

Download Brochure Advance GMP II – Sterile Medicinal Products 03_11_2022

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

Understand the principals of Production Technology for sterile medicinal products
Understand the contamination control strategy
Describe the premises for a clean area and clean area monitoring
Understand the principles of specific technology for the sterile medicinal product manufacturing

KEY TOPICS

Pharmaceutical Quality System (PQS)
Personnel
Equipment
Premises clean area and monitoring
Production Technology
Specific Technologies
Processing (Production-Sterilization)

WHO WILL ATTEND
Professionals working in:

Production – OSD
Pharma Regulatory Affairs
Product Development
Production Engineers
Quality Assurance
Pharmacist
Compliance

Advance GMP I Oral Solid Dosage Form 2 November, 2022 Riyadh
2022-11-02 09:00 - 16:30
Note: All training programs require physical presence 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 1 November, 2022.

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 implementation. This training will also enhance understanding and be beneficial to persons who work in product development and Technology transfer, regulatory affairs, pharmaceutical manufacturers, production engineering, site engineering, project engineering, Quality Operations, facility support services etc.

Download Brochure Advance GMP I – Oral Solid Dosage Form 02_11_2022

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

Understand the principals of SFDA GMP guidelines.
Describe the Pharmaceutical Quality System concept, objectives and state of control.
Understand the life-cycle stages and Management responsibility.
Describe the prerequisite for the pharmaceutical quality system.
Understand the principles of developing, designing and implementing the Pharmaceutical Quality System at Oral Solid manufacturing facility.

KEY TOPICS

Pharmaceutical Quality System (PQS)
PQS- GMP for Medicinal Products
Personnel
Premises and Equipment
Production – Oral Solid Dosage Form
Case studies and Best practices

WHO WILL ATTEND
Professionals working in:

Production – OSD
Pharma Regulatory Affairs
Product Development
Production Engineers
Quality Assurance
Pharmacist
Compliance

Basic of Good Manufacturing Practice (GMP) SFDA Explained 1 November, 2022 Riyadh
2022-11-01 09:00 - 16:30
Note: All training programs require physical presence 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 31 October, 2022.

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.

Download Brochure Basics of Good Manufacturing Practice (GMP) SFDA Explained 1_November_2022

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

Health and Herbal Products Development Process and Regulatory Approval 26 October, 2022 Riyadh
2022-10-26 09:00 - 16:30
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES

SAR 1500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 13th October 2022.

SAR 900.00

OVERVIEW
Understanding drug regulatory affairs in the GCC region is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working in the regulatory affairs departments or related fields, who need knowledge of the SFDA and GCC regulatory processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, project management and marketing, etc.

Download Brochure Health and Herbal Products Development Process, and Regulatory Approval_26_10_2021_Riyadh

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

Define the key principles and processes used by the Saudi Food and Drug Authority (SFDA) in regulatory submission and approval.
Define official regulatory policies and other issues pertinent to a successful SFDA and GCC regulatory strategy
Describe the requirements for marketing applications for

herbal and health products and document preparation.

Recognize SFDA oversight and processes during the post- approval phase.
Interact appropriately with the SFDA during all phases of drug registration

KEY TOPICS

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

WHO WILL ATTEND
Professionals working in:

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

Common Technical Documents (CTD) and (eCTD) preparation 25 October, 2022 Riyadh
2022-10-25 09:00 - 16:30
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 23 October, 2022.

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 25_October_2022 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

Preparing VNeeS Submission 24 October, 2022 Riyadh
2022-10-24 09:00 - 16:30
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 22 October, 2022.

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 Brochour Preparing VNeeS Submission_24_10_2022_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

CTD Quality Module 3 for new chemical and Generic products Chemistry, Manufacturing and Control (CMC) 12 October, 2022 Riyadh
2022-10-12 09:00 - 16:30
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 10 October, 2022.

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) 12 October, 2022 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.

Pharmaceuticals Pricing, Reimbursement and Market Access. SFDA System Explained 11 October, 2022 Riyadh
2022-10-11 09:00 - 16:30
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 9 October 2022.

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 Brochour Pharmaceuticals Pricing SFDA System Explained 11_October_2022, 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 Pharmacovigilance 3-4 October, 2022 Riyadh, Saudi Arabia
2022-10-03 09:00 - 2022-10-04 17:00
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 5000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 29th September, 2022.
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 3-4 October, 2022 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

SFDA Pharmacovigilance System Explained 27-28 September_2022, Riyadh, Saudi Arabia
2022-09-27 09:00 - 2022-09-28 17:00
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 5000.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 26 September, 2022.
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 27-28_Sept_2022 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 26 September, 2022 Riyadh
2022-09-26 09:00 - 16:30
Note: All training programs require physical presence 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 13 September 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 26_Sept_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 27-28 June_2022, Riyadh, Saudi Arabia
2022-06-27 09:00 - 2022-06-28 17:00
Note: All training programs require physical presence 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 23 June, 2022.
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 27-28_June_2022 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 22 June, 2022 Riyadh
2022-06-22 09:00 - 16:30
Note: All training programs require physical presence 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 7 June 2022.
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 22 June, 2022 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.

CTD Quality Module 3 for new chemical and Generic products Chemistry, Manufacturing and Control (CMC) 21 June, 2022 Riyadh
2022-06-21 09:00 - 16:30
Note: All training program require physical presence 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 7 June, 2022.
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) 21 June, 2022 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.

Common Technical Documents (CTD) and (eCTD) preparation 30 May, 2022 Riyadh
2022-05-30 09:00 - 16:30
Note: All training programs require physical presence 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 18 May, 2022.
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 30 May 2022 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

Advance Pharmacovigilance 24-25 May, 2022 Riyadh, Saudi Arabia
2022-05-24 09:00 - 2022-05-25 16:30
Note: All training program require physical presence 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 16 May, 2022.
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 24-25 May, 2022 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 18 May, 2022 Riyadh
2022-05-18 09:00 - 16:30
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 1500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 11 May 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 18_May_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 16-17 May_2022, Riyadh, Saudi Arabia
2022-05-16 09:00 - 2022-05-17 16:30
Note: All training programs require physical presence 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 11 May, 2022.
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 16-17_May_2022 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 14 March, 2022 Riyadh
2022-03-14 09:00 - 17:00
Note: All training programs require physical presence 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 10 March 2022.
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 March, 2022 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.

Common Technical Documents (CTD) and (eCTD) preparation 9 March, 2022 Riyadh
2022-03-09 09:00 - 17:00
Note: All training programs require physical presence 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 5 March, 2022.
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 9 March 2022 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

CTD Quality Module 3 for new chemical and Generic products Chemistry, Manufacturing and Control (CMC) 8 March, 2022 Riyadh
2022-03-08 09:00 - 17:00
Note: All training program require physical presence 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 3 March, 2022.
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) 8 March, 2022 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.

SFDA Pharmacovigilance System Explained 1-2 March_2022, Riyadh, Saudi Arabia
2022-03-01 09:00 - 2022-03-02 17:00
Note: All training programs require physical presence 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 24 February, 2022.
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 1-2_March_2022 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 February, 2022 Riyadh
2022-02-09 09:00 - 17:00
Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center

FEES
SAUDI RIYAL

REGISTRATION FEES
SAR 1500.00

EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 3 February 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 9_February_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 17-18 January, 2022 Riyadh
2022-01-17 09:00 - 2022-01-18 17:00
Note: All training programs require physical present 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 14 January, 2022.
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 17-18 January 2022 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 10 January, 2022 Riyadh
2022-01-10 09:00 - 17:00
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
