Drug Development

Certificate in Drug Development

The Drug Development Certificate teaches students the fundamental concepts affecting quality assurance and regulatory affairs that are so critical to the successful operation of the pharmaceutical and related industries.

It is, by far, our most popular certificate.

Its courses were developed and selected by Temple's QA/RA Steering Committee, a group of senior executives from the industry who meet with TUSP on a regular basis to advise on the development and direction of the Quality Assurance/Regulatory Affairs curriculum.

The four-courses provide a strong introduction to the language and terminology of the industry, along with an overview of how the industry achieves and maintains quality practices while meeting regulatory compliance at the local, national and global levels. 

Whether you are new to the industry or a more seasoned employee, you will learn the key role every industry position has in the safe and effective design of pharmaceuticals and medical devices.

Many students start their coursework in QA/RA with the Drug Development Certificate, since it enables them to explore the various career options in the pharmaceutical and related industries without committing themselves to the entire Master of Science degree or even a particular field of study.

The Certificate also enables those who intend to pursue the M.S. in QA/RA to earn well-recognized credentials for the first four courses they complete in our program.

To obtain the certificate, students must:

  • Submit the Drug Development Certificate application
  • Include photocopies of all undergraduate and graduate transcripts
  • Notify the QA/RA Office that they have completed the certificate courses

Students may apply for the program before starting the Certificate, but that is not necessary.  It is also acceptable for students to complete the four courses and then apply for the Certificate afterwards.

To receive a letter of completion for the Drug Development Certificate, the following courses must be successfully completed (grade of B or higher) within a three-year period:

  • Drug Development (Pharmaceutics 5459)
  • Food and Drug Law I (Pharmaceutics 5592)
  • Any Good Practices course (Pharmaceutics 5476 – GLPs OR Pharmaceutics 5477 – GMPs OR Pharmaceutics 5479 – Advanced GMPs – Defining “c” OR Pharmaceutics 5536 – GCPs)
  • One elective in the QA/RA program

Many students select IND/NDA Submissions or Quality Audit as their elective course in the Drug Development Certificate, since that enables them to complete the four required courses for the M.S. in QA/RA.

Brochure
Application Form
Notice of Completion