Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy
Drug Development Certificate (Pre-Master's)
"This Certificate demonstrates to my employers the progress I have made at Temple University School of Pharmacy. After completing six courses in the MS in RAQA program, I have learned about drug discovery and development, FDA regulatory submissions, GMPs and quality systems related to pharmaceutical manufacturing. I also earned this Certificate. As I continue on my journey to the MS degree, it is nice to be recognized for my progress. It is an honor to be part of this program and to have the opportunity to complete this Certificate. Thank you, Temple!"
"When I first began the RAQA MS program, I was interested in regulatory compliance and pursuing the dream of landing a career in RA. At the time, I was in a QA role in which I was exposed to the late stages of the drug development process (when drugs are transferred from R&D into production.) I wanted to gain an understanding of more of the drug development process than the limited scope that I at that time. I have recently made a career change into RA, where I will work on new projects in the development phases as well as life-cycle management activities. Pursuing the Drug Development Certificate will show my company the level of devotion that I have to the regulatory field and my willingness to build a better foundation for myself in the topics that I am responsible for performing. I believe that it is paramount for not only myself but for others in the industry to learn from each other in order to make our industry the best that we can. Gaining the Drug Development Certificate shows that I am consciously striving for improviement, seeking different perspectives, and wanting to serve my company better."
The Drug Development Certificate explores fundamental concepts and current issues affecting quality assurance practices and regulatory affairs that are critical to the pharmaceutical, biotechnology, medical device and related industries.
This four-course program is the most popular certificate, since it includes three of the required courses for the MS in RAQA. Students new to the industry are introduced to industry terminology, quality practices, and regulatory compliance. More seasoned employees discover how critical their job is to the entire drug development process and achieve a deeper understanding of industry concerns.
This certificate allows students to explore QA and RA issues without committing themselves to the entire Master of Science program.
The GRE is not required for the Drug Development Certificate.
To obtain the certificate, students must submit an application and photocopies of their undergraduate transcript(s). Students may complete the four courses, before formally applying for the certificate.
All courses taken for the Drug Development Certificate will count towards the MS degree, as long as students are eligible for admission to the RA and QA master's degree and apply to the MS program before completing their third course.
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 (5459)
- Food and Drug Law (5592)
- Any Good Practices course: GLPs (5476) or GMPs (5477) or Advanced GMPs - Defining "c" (5479) or GCPs (5536)
- One RAQA elective (the elective can be Quality Audit (5494) or IND/NDA Submissions (5495) or any course in the RAQA program)
Transfer credits are not accepted towards Temple’s certificate programs.
Brochure - Drug Development Certificate
How to Receive the Certificate when you've completed the courses:
Submit the following items to the RAQA Office (hard copy only):
2. Photocopies of your undergraduate and graduate transcripts.
3. A transcript from Temple's Banner system of courses taken in the RAQA program.
4. Notice of Completion
All materials must be received by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.
Note: Students may obtain only one certificate before completing the MS program, except for Food RA and QA.