Course Details

Safety of therapeutics is an important concern along the course of drug development extended from bench-side research to manufacturing process and even before and after the drug is applied to the patient. Testing of drugs, medicine, raw materials and adjuvants, or even methods to validate the tests, are have to be carried out completely in accordance to the regulation of the country of origin or to which the product will be marketed, and as well the pharmacopoeias and valid standards at pharmaceutical practice. As biopharmaceuticals include a wide range of biological candidates including living cells, the production of biopharmaceuticals is therefore a very stringent process and involve multiple measures to ensure the safety of therapeutics. By studying this course, students will be exposed to topics on how biologics are developed, tested, manufactured, and how to ensure their safety and efficacy before they are applied to human beings. Students will also understand the quality control measures and different accreditation systems in relation to drug development and manufacturing.