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. Students complete the following courses:
- 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)
All courses may be completed online. 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.
All courses taken for the Drug Development Certificate will count toward 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. Students may obtain only one certificate before completing the MS program, except for Food RA and QA.
Application Information for RAQA Pre-Master's Certificates
Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal.
Application Process for RAQA Pre-Master's Certificates
- Call the RAQA office at 267-468-8560 to speak with a program representative
- Set up an account on our Graduate Application Portal. Once you complete the form, you will receive an email to complete your set up.
- Complete all of the required personal information in the Application Portal.
- Submit all required documents, as listed below.
Once all documents have been received, your application will be submitted to our review panel for evaluation. A representative will be in touch within a week of submitting your application with a timeline for an admissions decision.
Application Requirements for RAQA Pre-Master's Certificates
- A baccalaureate degree, with an undergraduate GPA of 3.0 or higher.
- Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to [click-for-email]. Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy.
- Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider, either World Education Services (WES) or Educational Credential Evaluators (ECE).
- Resume: Current resume or CV is required.
- Statement of Goals: In approximately 500 to 1,000 words, applicants should state their specific interest in Temple's program, research goals, future career goals, and academic and research achievements.
- Standardized Test Scores: Applicants who earned their baccalaureate degree from an institution where the language of instruction was other than English, with the exception of those who subsequently earned a master's degree at a U.S. institution, must report scores for a standardized test of English that meet these minimums:
- TOEFL iBT: 85
"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!"
RAQA Student
"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. I wanted to gain an understanding of more of the drug development process. 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. 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 improvement, seeking different perspectives, and wanting to serve my company better."
RAQA Student
Questions?
Reach out to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.
Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance
425 Commerce Drive, Suite 175
Fort Washington, PA 19034
267-468-8650
QARA@temple.edu