Drug Development Certificate 

The Drug Development Certificate in the School of Pharmacy at Temple University is specifically designed for pharmaceutical and healthcare professionals who actively contribute to the drug development process or aspire to pursue a career in the pharmaceutical industry. This certificate is part of the School of Pharmacy’s regulatory affairs (RA) and quality assurance (QA) graduate program. 

Regulations governing the pharmaceutical industry at the state, federal and global levels continue to expand and change. Quality assurance principles are the core of pharmaceutical discovery, manufacturing, clinical trials and validation processes. Familiarity with the latest trends and current practices in regulatory affairs is critical to any industry professional’s success.  

The Certificate in Drug Development enables students to explore quality assurance and regulatory affairs as a prospective career path without committing to the entire master’s degree. The certificate provides the tools and information needed to understand the basis for new drug discovery; the Federal Food, Drug and Cosmetic Act; and good pharmaceutical practices as they apply to the clinical, laboratory or manufacturing components of the drug development process.  

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

Regulatory Affairs and Quality Assurance at the School of Pharmacy 

For over five decades, Temple University’s School of Pharmacy has provided outstanding graduate-level coursework in RA and QA. Regulatory affairs and quality assurance are the practices through which professionals ensure that products comply with government regulations and meet industry standards.

The School of Pharmacy  

  • pioneered RA and QA graduate education in 1968, offered the first RA and QA online degree program and offers the most comprehensive RA and QA curriculum;   

  • has outstanding expert faculty from industry and the U.S. Food and Drug Administration (FDA), assuring the latest developments and practices are taught; 

  • attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare); 

  • schedules live courses with interactive discussions and workshops on evenings and weekends; 

  • has hundreds of students from across the country, facilitating great networking opportunities; and 

  • provides individualized services to students.    

Certificates provide credentials from Temple’s well-respected RA and QA graduate program, which can be applied to the RA and QA master’s degree. 

Program Format & Curriculum  

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

  • Drug Development (5459) 

  • Food and Drug Law (5592) 

  • One Good Practices course: either Good Laboratory Practices (5476) or Good Manufacturing Practices (5477) or Advanced GMPs—Defining “c” (5479) or Good Clinical Practices (5536) 

  • One elective from Temple’s RA and QA program (students should take Drug Development or Food and Drug Law before other courses) 

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 completed an identical course at an accredited U.S. graduate school, the student may petition the RA and QA program to waive that course 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 Drug Development Certificate.

See the curriculum.

Requirements 

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

  • The certificate must be completed within three years.  

  • Students must apply for the certificate no more than one year after completing the course requirements.

Learn more about the application process.

Related Graduate Degrees

Tuition & Fees

In keeping with Temple’s commitment to access and affordability, this program offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates at Temple University are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more.

You can view the full Cost of Attendance breakdown on the Student Financial Services website. You can also view the the tuition rates for the 2024–2025 academic year. 

Accreditation

Temple University’s departments and programs are accredited by the Middle States Commission on Higher Education.

PH-DRGD-GRAD

Additional Program Information

Available online.

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