InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$390 USD / 22500 INR.
Buy NowBook Now
Saudi drug registration and regulation training


Course Type

Course Duration



Who should attend


Course Deliverable

Related Courses

About RA

drug registration in Saudi Arabia

This drug regulatory affairs course “Drug Registration and Regulation in Saudi Arabia” provides training on marketing authorization process in Saudi Arabia. The course provide detail training on drug Registration Procedure in Saudi Arabia. It covers recent regulations, marketing authorization procedure, country specific Common Technical Documents, guidelines and dossier preparation. Moreover course focus on the regulatory affairs strategic planning for marketing authorization for different class of pharmaceutical, biopharmaceutical in Saudi Arabia. Hence, this course is vastly useful for those who want to know or already working in regulatory affairs. This course will help them to enhance competency to handle Saudi Arabia Marketing Authorization Application effectively.

The course is designed to challenge students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.

The course can be completed at any place, allowing the user to stop and start at their leisure.

Course Code: RYD-065

Course Title: Advance Certification in Drug Registration & Regulation in Saudi Arabia

Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.

1 Month

This Saudi Arabia Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the Saudi Arabia pharmaceutical market. Therefore, this online certification course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel. Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.

Key features of the course

  • Orientation to practical understanding in the entire drug regulation, registration procedure of Saudi Arabia. Moreover, course also focus on Common Technical Documents, guidelines and drug dossier preparations. Moreover, course explains various marketing authorization strategic pathways. This helps to enhance the regulatory strategic decision making skill.
  • The course extensively covers marketing authorization requirements for full application, verification pathway and abridged pathway. Hence, the course will nurture the regulatory strategic decision making skills.
  • Moreover, this training covers variations and renewals of marketing authorization specific to pharmaceutical registration in Saudi Arabia.
  • This training program has advance sessions on CMC preparation, Stability Study, Drug Master File Preparation, Site Master File Preparation, Good Manufacturing Practices modules.
  • The course is self paced. Hence, course can be accessed 24×7, anytime, anywhere across the globe.
  • Moreover, students can download the course material hand out by login to dashboard. Hence, it helps them to study offline even after completion of the course.
  • Final examination is online. Hence, student can attend the final certification examination at own convenient date and time.

Graduation in any discipline. Even the final year student can join the course.

  • Freshers and beginners. Those who want to know about the Saudi Arabia Pharmaceutical Market, Regulation.
  • Drug regulatory affairs professionals. Who want to enhance knowledge about the Saudi Arabia regulatory affairs.
  • Business Development, Regulatory Affairs, IPR, strategic management professionals who want to have the detailed understand strategic planning process for registration and regulation of the pharmaceuticals in Saudi Arabia.

 Certificate will be provided at the end of the successful completion of the course.

  1. Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also eligible to receive the course study modules, which you can download by login to your course page.

Few of the similar courses

Saudi Arabia Pharmaceutical Market

Saudi Arabia is the largest, and one of the most developed economies in the Middle East. Hence, Saudi pharmaceutical market presents significant growth opportunities for local and multinational drug makers. Recent days, expansion of private healthcare coverage and the modernization of health infrastructure will contribute to drive prescription market growth. But stricter pricing controls, generic drug substitution and an unfavorable demographic profile are the few of the challenges of Saudi Arabia pharmaceutical market. However, there is huge scope for the MNC and domestic pharmaceutical companies.

The Saudi Arabia Pharmaceuticals market estimated to be valued approximately US$ 5.8 billion in 2017 and poised to grow at CAGR 6.7%. Market for Saudi Arabia Pharmaceuticals projected to reach US$ 8.5 billion by 2023. Therefore, pharmaceutical market in Saudi Arabia is going to witness significant growth in coming years.

As we discussed, there are lot of regulatory changes as far as the the drug registration and regulation in Saudi Arabia. So, the major objective of the regulatory changes to maintain safety and efficacy of the drugs and bio molecules.

About Saudi Arabia Drug Regulatory Affairs Course

In this Saudi Arabia drug regulatory affairs course, focus is on learning the fundamental to advance learning regarding drug discovery, development to commercialization process. Secondly, course is designed to provide comprehensive training on marketing authorization process for pharmaceutical, biopharmaceutical. Above all, course provide extensive training on drug authorization dossier preparation. In addition, course provide access to case simulations and case studies pertaining to drug registration in Saudi Arabia. Certainly, this help all students to acquire practical understanding regarding marketing authorization process in Saudi Arabia.

About regulatory affairs job>> Learn here

Section 1Fundamental Sessions
Lecture 1Understanding on Drug Discovery Development Process to Commercialization
Lecture 2Investigational New Drug and Investigational New Drug Application
Lecture 3Understanding on New Drug and New Drug Application
Lecture 4Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 5Basic concept and understanding of the Generic Drug
Lecture 6Abbreviated New Drug Application (ANDA) 
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8Handling of orange book
Lecture 9Expedited programs
Lecture 10Clinical Trial Fundamental Understanding
Section 2Saudi Arabia Marketing Authorization Process
Lecture 11Marketing Authorization Process in SFDA | Product Types and classes | Submission Pathways | SFDA MA Variation | Renewals | Handling SDR online submission process
Lecture 12Chemistry, Manufacturing & Controls 
Lecture 13Advance Understanding on Submission Dossier (Common Technical Document (CTD)
Lecture 14Advance Practical Training on Dossier Preparation focusing on drug registration in Saudi Arabia
Lecture 15CMC Dossier & Compliance Management
Lecture 16Comparison of GCC requirements with other regions
Lecture 17Key Consideration for Drug Master File Preparation and Submission 
Lecture 18Practical Training on preparing DMF and SMF
Lecture 19Site Master File
Lecture 20Importance of effective dossier management
Lecture 21Discussion on 85 common deficiency in CTD submission dossier
Lecture 22Electronic Common Technical Document (ECTD) Training
Section 3GMP Management and Plant Inspection Handling
Lecture 23Premises & Plant Layout Designing
Lecture 24Sanitation and Hygiene
Lecture 25Equipment
Lecture 26Production Module
Lecture 27Documentation
Lecture 28Quality Control
Lecture 29Handling of Product Complaint
Lecture 30Storage Module
Section 4Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 31Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 32Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 33Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 34RTQs | Response to Queries | How to handle Regulatory Queries  
Section 5Stability Study
Lecture 35Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 36Climatic Zone and Stability Study Conditions as per ICH Guidelines 
Lecture 37Stability Zone Finder
Lecture 38Stability Studies Case Discussions
Lecture 39Case Study: Managing Stability Study for Zone IV countries
Lecture 40Accelerated and intermediate testing conditions
Lecture 41Long Term Stability Testing Requirements
Lecture 42Stability Study Protocol Development - Dosage form: Capsule
Lecture 43Stability Data Sheet
Lecture 44Dossier Stability Test
Lecture 45Testing Frequency
Lecture 46Bracketing
Lecture 47Matrixing
Section 6Variation Management
Lecture 48Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 49Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline
Section 7PKPD | Bioequivalence Study
Lecture 50PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 51Bioequivalence Study | Study design | Different types of BE Studies
Lecture 52Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 53Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 54Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 55Bioequivalence Study - Discussion - Dissolution Testing
Lecture 56Bioequivalence Study - Generic Approval and Additives Labeling Requirements