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M.Sc of Pharmaceutical regulatory affairs - (2026)
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Department Compulsory Req. (25) Hours:
Line No.CodeCourseHoursPrerequisiteTeaching Method 
347000RA700 regulatory affairs for drugs 3---Blended
347010RA701 regulatory submissions and documentation practice 3---Blended
347020RA702 regulatory fundamentals of human research 3---Blended
347030RA703 pharmacovigilance and post-approval changes 3---Blended
347040RA704 seminar 1---Blended
347050RA705 good practices in pharmaceutical regulations 3---Blended
347060RA706 biologics/ biosimilars: a regulatory overview 3---Blended
347070RA707 regulatory affairs of over-the-counter drugs, dietary supplements and medical devices 3---Blended
347080RA708 practicum 3---Blended

Department Elective Req. (9) Hours:
Line No.CodeCourseHoursPrerequisiteTeaching Method 
307022PHAR702 applied statistics 2---Blended
307581PHAR758 drug stability 3---On Campus
347090RA709 strategic planning and project management for regulatory affairs 3---Blended
347100RA710 ethics in clinical and non-clinical trials 3---Blended
347110RA711 risk management compliances 3---Blended
347120RA712 pharmaceutical analysis and validation 3---Blended
347130RA713 validation of manufacturing facilities, utilities and equipment 3---Blended
347140RA714 food labeling and regulatory affairs 3---Blended
347150RA715 regulatory communication 3---Blended
347160RA716 artificial intelligence in regulatory affairs 3---Blended
347170RA717 pharmaceutical quality management 3---Blended
347180RA718A selected topics in regulatory affairs 1 1---Blended
347181RA718B selected topics in regulatory affairs 2 2---Blended
347182RA718C selected topics in regulatory affairs 3 3---Blended

Specialization Compulsory Req. (0) Hours:
Line No.CodeCourseHoursPrerequisiteTeaching Method 
347980RA798 comprehensive exam 0---On Campus