Learn about the U.S. and global regulations governing the labeling, advertising, and promotions of pharmaceuticals and related products. Often this area is an excellent way to enter industry.
The Certificate discusses the complexity of the PI (Prescribing Information), showing how it must delineate every aspect of the product, from its dosage form to its unique storage requirements and dosage information. Topics include how the PI must be incorporated into print and Internet advertising and promotions for products and also discuss requirements of TV ads. Differences of regulations in key world markets are also discussed.
There continues to be a demand for regulatory professionals with demonstrated knowledge in labeling, advertising, and promotions. This certificate provides that skill set.
Required courses:
- Food and Drug Law (5592)
- Requirements for Product Labeling and Advertising (5533)
- Global Labeling Regulation: Principles and Practices (5532)
- Regulation of Advertising and Promotions (5611)
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 Pharmaceutical Labeling, Advertising and Promotions Certificate.
All courses taken for the Pharmaceutical Labeling, Advertising and Promotions 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
I have been in the pharmaceutical industry for more than 29 years with the majority of that time spent doing bench level laboratory work and more recently as a Clinical Pharmacologist. Although I gained a large amount of practical experience in Regulatory Affairs throughout my career, I previously had no formal education or training in this area. It is only within the last year and a half that I joined the Global Labeling Department at my company. The courses I completed in pursuit of the Certificate in Pharmaceutical Labeling, Advertising, and Promotions expanded my knowledge in this area of RA and were extremely helpful to me in my current position. Obtaining this certificate will help me to further advance within my department as I pursue my MS in RAQA.
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