Understanding Generic Drug Registration In Saudi Arabia, Ksa

Master SFDA Guidelines, Generic Drug Registration, CTD Preparation, and Regulatory Pathways in Saudi Arabia.

What you'll learn

Understand the SFDA guidelines for generic drug registration in Saudi Arabia.

Identify and apply the correct registration pathway for generic drugs.

Compile and submit a comprehensive Common Technical Document (CTD) dossier.

Analyze real-world case studies to make informed decisions during the registration process.

Navigate intellectual property challenges, including Freedom to Operate (FTO) considerations for patent-protected drugs.

Develop pricing strategies for generic drugs in alignment with SFDA policies and KSA's reference pricing system.

Manage post-approval requirements, including pharmacovigilance and marketing authorization renewals.

Requirements

No prior experience in regulatory affairs is necessary; everything will be covered in the course.

Basic understanding of the pharmaceutical industry is helpful but not mandatory.

(Optional) Familiarity with regulatory documentation, such as CTDs, or experience in pharmacovigilance, will provide added context.

Description

Discover the latest from generic drug registration in Saudi Arabia with this detailed course for professionals and newcomers alike. Explore SFDA regulations to the fullest and dive through the intricate pathways of regulations that lead in the proper route towards successfully bringing generic drugs into the market.Key areas covered: Understanding guidelines and regulatory frameworks issued by SFDA.Prepare and submit the Common Technical Document (CTD) dossier.Intellectual property considerations and pricing strategies.Handling post-approval requirements, pharmacovigilance, and adverse drug reaction reporting.As such, this class provides real-life case studies, quizzes, and actionable insights to help you get equipped with adequate knowledge and tools to excel in the pharmaceutical industry. Be a regulatory affairs professional, pharma entrepreneur, or aspiring expert, but you will find your gateway to the successful KSA market for the course.From working through case studies and quizzes, you will build practical experience, so the knowledge you will gain will be directly applicable. Through insights into SFDA's latest guidance and steps for selecting the optimal registration pathway, you'll be better equipped to overcome regulatory challenges and make the right decisions.Enroll now to acquire the skills and confidence to excel in this niche area of high demand in pharmaceutical regulation. Let's start our journey together!

Overview

Section 1: Introduction

Lecture 1 Introduction

Lecture 2 Why This Course is Your Key to Unlocking the KSA Pharma Market

Lecture 3 What are we going to learn and understand

Section 2: Chapter 1: Introduction to SFDA Regulations and Generic Drugs

Lecture 4 SFDA's Responsibilities

Lecture 5 Definition and characteristics of generic drugs

Lecture 6 Regulatory framework for generic drugs

Lecture 7 Case Study

Section 3: Chapter 2: Registration Pathways for Generic Drugs

Lecture 8 Introduction

Lecture 9 Full application for generic drugs with no reference product

Lecture 10 Abridged application for generic drugs with a reference product

Lecture 11 Verification pathway for generic drugs from specific countries

Lecture 12 Choosing the right path: Factors to consider

Lecture 13 Case Study

Section 4: Common Technical Documents

Lecture 14 Structure and content of the CTD dossier for generic drugs

Lecture 15 Module 1: Regional Administrative Information (specific to SFDA requirements)

Lecture 16 Module 2: Common Technical Document – Summaries (selection of relevant sections)

Lecture 17 Module 3: Quality (CMC) data requirements for generic drugs

Lecture 18 Module 4: Non-clinical Study Reports (selection based on reference product)

Lecture 19 Module 5: Clinical Study Reports (waiver possibilities for generics)

Lecture 20 Case Study

Section 5: Chapter 4: Intellectual Property Considerations for SFDA Generic Registration

Lecture 21 Different paths depending on the original product's patent situation

Lecture 22 Case Study

Section 6: Chapter 5: Pricing in SFDA

Lecture 23 Pricing in SFDA

Section 7: Chapter 6: Post-Approval Requirements and Pharmacovigilance

Lecture 24 Variations and Renewals of Marketing Authorization

Lecture 25 Post-marketing surveillance and pharmacovigilance obligations

Lecture 26 Reporting adverse events to the SFDA

Lecture 27 Case Study

Lecture 28 Conclusion

Pharmaceutical professionals looking to enter the Saudi market with generic drugs.,Regulatory affairs specialists who want to deepen their knowledge of SFDA guidelines.,Pharma entrepreneurs aiming to navigate the complexities of drug registration in KSA.,Professionals interested in understanding the Common Technical Document (CTD) process and pharmacovigilance requirements.