Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy
Labeling, Advertising, and Promotions Certificate (Pre-Master's)
"I have been in the pharmaceutical industry for more than 29 years with the mojority 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 hlaf that I joined the Global Labeling Department at my company. The courses I completed in pursuit of the Certificate in 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."
Learn about the U.S. and global regulations governing the labeling, advertising, and promotions of pharmaceuticals and related products.
The Certificate discusses the complexity of the PI (Package Insert), 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.
- Food and Drug Law (5592)
- Requirements for Product Labeling and Advertising (5533)
- Regulation of Advertising and Promotions (5611)
One elective from:
- Global Labeling Regulation (5532)
- Advanced Topics in Labeling Development (5535)
- Regulation of Non-Prescription Healthcare Products (proposed 5507)
- Regulation of Dietary Supplements, Botanicals, and Nutraceuticals (5594)
Transfer credits are not accepted towards Temple’s certificate programs.
Brochure - Labeling, Advertising, and Promotions 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.