Post-master’s Certificate in Biologics and Biosimilars: Regulatory Aspects 

Students have the option to complete a post-master’s curriculum in biologics and biosimilars: regulatory aspects in Temple’s School of Pharmacy, offered through the school’s RA and QA graduate program. 

This post-master’s certificate requires the completion of coursework focusing on the regulatory, strategic, technical and scientific issues that are unique to biologics and biosimilar drug manufacturers. To apply for this 15-credit program, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in biology, chemistry, engineering, pharmacy, physics or related fields. 

Learning Objectives

Upon completion of the post-master’s certificate, students will understand the

• U.S. and global regulatory landscape for biologics and biosimilars,

• differences between biologics and small molecules,

• the complexities and challenges in drug development across disciplines (e.g., toxicology, clinical and CMC),

• the strategy for preclinical and clinical studies as applied to biologics and biosimilar products, and

• the basics of biologics and biosimilar CMC strategies.