Course Details

Preventing and avoiding harm to patients is the most important concern when a candidate drug is able to translate from bench to bedside. Biological products include a wide range of biopharmaceuticals and biosimilars which involve living cells of human and non-human origins, therefore the handling and production of biologics involves prudent measures for ensuring product safety while maintaining efficacy.  Testing of drugs, medicine, raw materials and adjuvants, or validation of tests and equipment must be carried out in accordance with the regulation of the country of origin or which the product will be marketed, and meeting the quality as stipulated in the pharmacopoeias.  By studying this course, students will have an understanding of the overall concepts of Good Manufacturing Practice (GMP) and how it is applied in controlled facilities for biologics or advanced therapy medicinal products (ATMPs). Students will learn to solve problems by participating in discussions, case studies, and using innovative teaching tools.