Learn more about the graduate certificate in Drug Development.
About the Certificate
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 graduate certificate in Drug Development 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. Students explore regulatory affairs and quality assurance as a prospective career path without committing to a 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 (FD&C Act); and good pharmaceutical practices as they apply to the clinical, laboratory or manufacturing components of the drug development process.
Time Limit for Certificate Completion: 3 years
Campus Location: Online and Fort Washington
Full-Time/Part-Time Status: The certificate may be completed on a part-time basis. NOTE: International students may not be eligible to apply for a student visa based on admission to the certificate program. Please contact the School of Pharmacy's program coordinator for more information.
Non-Matriculated Student Policy: Non-matriculated students may take up to 9 credits of coursework before applying to the certificate program.
Admission Requirements and Deadlines
Application Deadline:
Fall and Spring admissions are on a rolling basis. Interested students should contact the School of Pharmacy for permission to enroll in coursework.
APPLY HERE to the post-baccalaureate certificate program.
Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a bachelor's degree from an accredited institution. While no specific major is required, most applicants should have a background in biological sciences, engineering, healthcare, natural sciences or related discipline.
Certificate Requirements
Number of Credits Required to Complete the Certificate: 12
Required Courses:
| Code | Title | Credit Hours |
|---|---|---|
| Core Courses | ||
| QARA 5459 | Drug Development | 3 |
| QARA 5477 | Good Manufacturing Practices 1 | 3 |
| QARA 5592 | Food and Drug Law | 3 |
| Elective 2 | 3 | |
| Total Credit Hours | 12 | |
- 1
It is strongly recommended that students take QARA 5477. Depending on their career path in industry, however, students may request to instead take QARA 5476 Good Laboratory Practices, QARA 5479 Advanced Good Manufacturing Practices - Defining "c" or QARA 5536 Good Clinical Practices. Permission from the Advisor is required.
- 2
Students may select any elective course in the Regulatory Affairs and Quality Assurance (RAQA) MS program for the elective, which allows maximum flexibility to pursue a particular career objective. Those, however, who want to complete the four requirements for the master's degree in RAQA should take QARA 5494 Quality Audit or QARA 5495 Investigational New Drug/New Drug Application Submissions as their elective for the certificate.
GPA Required to be Awarded the Certificate: 3.0 minimum
Contacts
Certificate Program Web Address:
Department Information:
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2728
267-468-8560
Mailing Address for Application Materials:
Temple University
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2728