Ahmed Hathal

Understand national and international regulations in the areas of Development, Manufacturing, Registration and Marketing of Pharmaceutical and Medical products. By learning the following: • Demonstrate an understanding of the rules and responsibilities of regulatory authorities in ensuring the safety, quality and effectiveness of pharmaceutical products. • Compare the basic principles and practices of quality management (QM), quality assurance (QA), and quality control (QC) in the pharmaceutical industry and explain regulatory compliance standards for local and international codes of ethics. • Evaluating health policy, linking it to regulatory policies, and clarifying the basic principles and concepts of pharmaceutical economics. • Distinguish pharmacokinetic concepts and requirements for registering drug products. • Explain all development stages of pre-clinical studies for potential drugs and manage clinical trials according to regulations. • Explain all steps of the upstream and downstream manufacturing process and apply good manufacturing practices (GMP) throughout the life cycle of pharmaceutical and biologic products. • Preparing a file with all regulatory requirements to submit a product to be registered with the Saudi Food and Drug Authority and the Gulf Cooperation Council countries. • Define and use biostatistics concepts and research methodology necessary for biomedical research. • Explain domestic and international practices for herbal products and supplements, veterinary products, regulations and guidelines for cosmetics and their potential risks. • Determine the principles of pharmacovigilance and drug safety of pharmaceutical products.