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.


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