Generic Drugs Certificate

The Generic Drugs Certificate in the School of Pharmacy at Temple University features a specialized curriculum that delves into domestic and global regulations for generic products. This certificate is part of the school’s regulatory affairs (RA) and quality assurance (QA) graduate program. 

Starting with an overview of the drug development process, courses explore the global marketplace for generic drugs, building a strong foundation in generic regulatory issues, including the abbreviated new drug application (ANDA) process. Students learn the key trends and controversies facing the generic industry as well as how generic drugs are manufactured and regulated nationally and globally. Students also cover topics such as the issues unique to generic drug manufacturers as well as regulatory issues critical for industry professionals to understand how to help companies create safe and effective bioequivalent products.  

The Certificate in Generic Drugs enables students to sharpen their knowledge of this industry niche without committing to the entire RA and QA master of science degree.  

Learning Objectives 

Students completing the certificate will become familiar with the following topics. 

• Domestic and global regulations for generic products 

• The competitive environment for generic products

• Manufacturing science and quality practices

Post-master’s Certificate in Generic Drugs

Students have the option to complete a post-master’s curriculum in generic drugs. This post-master’s certificate focuses on the regulatory issues that are critical for generic industry professionals to understand if they are to ensure that their companies create safe and effective bioequivalent drugs. To apply for this 12-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.

Learn more about the Graduate Certificate in Generic Drugs.

Program Format & Curriculum 

To pursue the Generic Drugs Certificate, students must have a bachelor’s degree in science, such as biology, chemistry, engineering, pharmacy, physics or related fields from an accredited institution of higher learning.  

In addition, students need a basic knowledge of pharmaceutical manufacturing processes, such as completion of Good Manufacturing Practices (5477) or Advanced GMPs—defining “c” (5479).  

The Certificate in Generic Drugs may be earned on its own or on the way to the MS in RA and QA. To earn the certificate, five courses must be successfully completed within a four-year period with an overall B (3.0) average.  

There are two required courses. 

• Drug Development (5459) 

• Generic Drug Regulation: ANDAs (5473)  

Students must also complete three electives from the following.  

• The Global Biopharmaceutical Industry (5458) 

• Drug Dosage Forms (5499) or Solid Dosage Forms—Small Molecules (8004) 

• Active Pharmaceutical Ingredients (APIs) (5513) 

• Good Distribution Practices (Pharmaceutics 5543) 

• Global Pharmaceutical Excipient Regulation (5546) 

• Global CMC Issues and Regulatory Dossiers (5576) 

• Analytical Chemistry in Pharmaceutical Laboratories (5655) 

• Special Topics: Current Issues Affecting the Generic Drug Industry (5650) 

All courses must be completed from Temple University’s RA and QA graduate program. No transfer credits from other institutions are accepted. If a student has taken an identical course at an accredited U.S. graduate school, the student may petition the RA and QA program to waive that requirement and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate. 

Learn more about the Generic Drugs Certificate.

See the curriculum. 

Requirements 

• Candidates must formally apply and follow the application procedures. 

• Only one certificate may be earned before students receive the MS. 

• The Certificate in Generic Drugs must be completed within four years. 

• Students must apply for the certificate within one year of completing all required coursework for the program. 

• Students interested in pursuing the RA and QA MS program may apply all credits earned from the Certificate in Generic Drugs toward their graduate degree, provided they formally apply for admission to the MS program and are accepted by Temple University’s graduate school.

Related Graduate Degrees

• Regulatory Affairs and Quality Assurance MS