Pharmaceutical Labeling, Advertising and Promotions Certificate
The Pharmaceutical Labeling, Advertising and Promotions Certificate in the School of Pharmacy at Temple University focuses specifically on the complex regulations associated with federal and global regulations governing labeling, advertising and promotions. This certificate is part of the school’s regulatory affairs (RA) and quality assurance (QA) graduate program program and is available online. A master’s degree is not required to earn this certificate.
In the pharmaceutical industry, labeling refers to more than a prescription label or a cardboard container enclosing prescription or over-the-counter (OTC) products. Labeling also refers to the prescribing information (PI), which is a detailed and complicated product reference sheet, often folded in multiple accordion pleats and included with prescription or OTC products. In the U.S., each PI is governed by the U.S. Code of Federal Regulations, Title 21, part 200, which stipulates that every aspect of the product be delineated in writing. This includes the following.
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A description of the drug dosage form and its physical properties
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A listing of active ingredients and excipients
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The molecular structure of each compound
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The pharmacokinetics and toxicology of the drug
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The intended patient population
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Potential side effects and safety concerns
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Unique storage requirements
The PI must accompany any print ads about prescription drugs that appear in journals and magazines. Attached to each advertisement, the PI must be uniquely coded, since the company is required to keep accurate records of where the ad appeared.
Federal regulations also govern how prescription products can be advertised. Each year, pharmaceutical companies spend billions nationally on direct-to-consumer TV ads, which have made many products household names. The complexity of creating these ad campaigns while complying with federal regulations continues to be a challenging task that combines industry knowledge, regulatory expertise and marketing. Advertising companies alone cannot create the ads; regulatory professionals must be included. In addition to direct-to-consumer advertising, websites about pharmaceutical products have grown exponentially, particularly those that focus exclusively on one product, serving as a “patient reference page.” In some cases, innovator companies even sell products directly to consumers from websites.
Countries often have unique regulatory requirements for labeling and advertising. For instance, some require labels to display the price of a product the day it was granted approval by the governing regulatory authority. In other cases, product cartons must be designed to clearly display that pricing.
As the types and global reach of product advertising continue to expand—thereby crossing the boundaries of regulatory authorities and patient populations—the need for more global regulatory oversight is increasing. Recruiters from placement firms frequently call Temple’s RA and QA office, seeking candidates with a demonstrated knowledge of the regulations governing advertising and labeling.
The Certificate in Pharmaceutical Labeling, Advertising and Promotions provides students with credentials from Temple’s well respected RA and QA graduate program, giving them a solid grounding in the key federal and global regulations that affect the advertising and labeling of pharmaceutical products. The certificate is open to both MS applicants and MS graduates, who can expand their career opportunities with this new credential.
Learning Objectives
Upon completion of the Labeling, Advertising and Promotions Certificate, students will be able to
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understand U.S. and global regulatory and industry requirements for creating, updating or maintaining product labeling;
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explain the nature of the pharmaceutical marketplace and the roles of Congress, the courts and the Food and Drug Administration in labeling, advertising and promotional efforts;
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evaluate specific advertising and promotion communications for regulatory compliance; and
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identify the latest trends and issues posed by internet advertisements and product websites.
Post-master’s Certificate
Students have the option to complete a post-master’s curriculum in pharmaceutical labeling, advertising and promotions. To apply for this 12-credit program, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in biochemistry, biology, chemistry, physics or a health-related discipline. Additionally, applicants who did not earn their master’s degree from Temple University’s School of Pharmacy must have sufficient industry experience and familiarity with the basic tenets of regulatory affairs and quality assurance to pursue the post-master’s certificate.