Degree Title

Executive Master's in Pharmaceutical Regulations.

Language of Instruction

English.

Program Vision

To elevate the quality of the healthcare sector by cultivating human capital proficient in pharmaceutical regulatory affairs.

Program Mission

To deliver exceptional education in pharmaceutical regulations and contribute to building a knowledge-based economy for the healthcare community through education, critical thinking, and leveraging domestic and international expertise in related fields.

Program Objectives

To meet the Kingdom's need for qualified practitioners in pharmaceutical regulations and to establish a solid understanding of national and international systems governing the development, manufacturing, registration, and marketing of pharmaceutical and medical products.

Graduates of this program will be able to:

1. Demonstrate understanding of the rules and responsibilities of regulatory authorities in ensuring the safety, quality, and efficacy of pharmaceutical products.
2. Compare the fundamental principles and practices of quality management (QM), quality assurance (QA), and quality control (QC) in the pharmaceutical industry, and explain the regulatory compliance standards for local and international professional ethics codes.
3. Evaluate health policy, link it to regulatory policies, and clarify the fundamental principles and concepts of pharmaceutical economics.
4. Differentiate between the fundamental concepts of drug kinetics and the requirements for registering pharmaceutical products.
5. Explain all stages of preclinical development for potential drugs and manage clinical trials according to regulations and systems.
6. Explain all steps of primary and final manufacturing processes and apply good manufacturing practices throughout the lifecycle of pharmaceutical products and biological preparations.
7. Prepare a file with all regulatory requirements to submit a product for registration with the General Authority for Food and Drug and the Gulf Cooperation Council countries.
8. Identify and utilize the concepts of biostatistics and research methodology necessary for biomedical research.
9. Explain local and international practices for herbal products, supplements, veterinary products, cosmetics regulations, and their potential risks.
10. Identify the principles of drug vigilance and pharmaceutical product safety.

Program Beneficiaries

Pharmacists from government entities (such as the Saudi Food and Drug Authority, Ministry of Health, hospitals, and academic institutions), as well as private sector organizations related to the registration and regulation of medical products.

Admission Requirements

In addition to the admission requirements outlined in the unified regulations for postgraduate studies in Saudi universities and the organizational and executive rules and procedures for postgraduate studies at King Saud University, applicants must meet the following criteria:

1. Hold a Bachelor's degree in pharmacy or Doctor of Pharmacy (Pharm.D.) from King Saud University or a recognized university by the Ministry of Education, with a cumulative GPA of at least 2.75 out of 5, and a cumulative GPA of at least 3.75 out of 5 in pharmacy specialization courses.
2. Submit an English language proficiency test score.
3. Pass the written exam administered by the program council.

Degree Requirements

Students must successfully complete 36 credit hours of the program's courses, including the research project, as follows:

Target Audience

Students.

Study Time

Evening sessions (three days a week).

Program Fees

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Curriculum and Course Descriptions

Course Schedule and Lectures

Lecture Schedule for Batch 1445H (Semester 1, 1446H)

Lecture Schedule for Batch 1446H (Semester 1, 1446H)

Contact Information

EMDRA@ksu.edu.sa

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