The program aims to enhance the quality of the healthcare sector by developing qualified human capacities with advanced knowledge and professional expertise in pharmaceutical regulatory affairs.
Program Description
The program aims to develop advanced professional competencies in the legal and technical aspects of pharmaceutical regulation. The key learning outcomes include:
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Linguistic and Technical Competence:
Mastery of international regulatory frameworks, including the International Council for Harmonisation (ICH) guidelines, U.S. Food and Drug Administration (FDA) regulations, and the regulatory requirements applied in the Kingdom of Saudi Arabia. -
Scientific Competence:
In-depth understanding of the drug development lifecycle, from preclinical research and clinical trial design in accordance with Good Clinical Practice (GCP), to post-marketing activities and pharmacovigilance. -
Applied Regulatory Skills:
Ability to prepare and draft regulatory dossiers, manage projects, and analyze data related to the registration of pharmaceutical products. -
Impact on Health Policy:
Capacity to contribute to the development and improvement of healthcare practices and policies through evidence-based regulatory expertise. -
Leadership and Collaborative Skills:
Demonstrated ability to communicate effectively with regulatory authorities and stakeholders, as well as to lead research initiatives in the field of pharmaceutical regulation.
In addition to the admission requirements stipulated in the Unified Regulations for Graduate Studies in Saudi Universities and the regulatory and executive rules governing graduate studies at King Saud University, applicants must meet the following criteria:
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The applicant must hold a full-time bachelor’s degree in Pharmaceutical Sciences or a Doctor of Pharmacy (Pharm.D) from King Saud University or from another recognized institution, with a minimum grade of Good and a cumulative GPA of 2.75 out of 5.0 or its equivalent.
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Submission of an English language proficiency test result, or possession of an academic qualification completed in English from countries where English is the official language, in accordance with the approved list of the Deanship.
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The applicant must have a minimum of two years of professional experience.
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Successful completion of a written examination administered by the department, weighted at 25% of the admission criteria.
First Year – First Semester
| # | Course Code | Course Name | No. of Study Units (Lecture + Practical) |
|---|---|---|---|
| 1 | EDRA 511 | Drug Regulatory Systems Overview | 2 (2+0) |
| 2 | EDRA 512 | Quality in Pharmaceutical Industry | 2 (2+0) |
| 3 | EDRA 513 | Pharmaceutical Research Methods | 2 (1+2) |
| 4 | EDRA 514 | Pharmacoeconomics & Health Policy | 2 (2+0) |
| 5 | EDRA 515 | Drug Discovery & Preclinical Development | 2 (2+0) |
Total: 10 Study Units
First Year –Second Semester
| # | Course Code | Course Name | No. of Study Units (Lecture + Practical) |
|---|---|---|---|
| 1 | EDRA 521 | Regulation of Clinical Trials | 2 (2+0) |
| 2 | EDRA 522 | Chemistry, Manufacturing, & Controls | 2 (1+2) |
| 3 | EDRA 523 | Drug Regulatory Compliance & Enforcement | 2 (2+0) |
| 4 | EDRA 524 | Pharmacovigilance & Drug Safety | 2 (2+0) |
| 5 | EDRA 525 | Product Registration in Kingdom of Saudi Arabia | 2 (1+2) |
| 6 | EDRA … | Elective Course (1) | 2 (2+0) |
Total: 12 Study Units
Second Year – First Semester
| # | Course Code | Course Name | No. of Study Units (Lecture + Practical) |
|---|---|---|---|
| 1 | EDRA 531 | Regulation of Herbal Products & Health Supplements | 2 (2+0) |
| 2 | EDRA 532 | Regulation of Biologics & Biosimilars | 2 (2+0) |
| 3 | EDRA 533 | Regulation of Veterinary Products | 1 (1+0) |
| 4 | EDRA 534 | Regulation of Pharmaceutical Products | 2 (2+0) |
| 5 | EDRA 535 | Regulation of Cosmetic Products | 1 (1+0) |
| 6 | EDRA … | Elective Course (2) | 2 (2+0) |
Total: 10 Study Units
Executive Master in Drug Regulatory Affairs (Non-thesis Option)
A joint program between all departments of College of Pharmacy
Second Year – Second Semester
| # | Course Code | Course Name | No. of Study Units (Lecture + Practical) |
|---|---|---|---|
| 1 | EDRA 599 | Graduation Project | 4 (0+8) |
Total: 36 Study Units
List of Elective Courses
Students must select (2) courses from the following:
| # | Course Code | Course Name | No. of Study Units |
|---|---|---|---|
| 1 | EDRA 541 | Drug Supply Chain Management | 2 (2+0) |
| 2 | EDRA 542 | Principles of Drug Marketing & Advertising | 2 (2+0) |
| 3 | EDRA 543 | Drug Benefit–Risk Assessment | 2 (2+0) |
| 4 | EDRA 544 | Analytical & Biological Testing | 2 (2+0) |
| 5 | EDRA 545 | Pharmacoepidemiology Principles | 2 (2+0) |
Program Overview
To request more information about the program
Contact Admission
King Saud University