Prof. Bawazir Pharma Consulting Center

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 (Europe/Moscow) | 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.
