51动漫

Pharmaceutical Labeling, Advertising聽and Promotions Certificate聽

The Pharmaceutical Labeling, Advertising and Promotions Certificate in the School of Pharmacy at 51动漫 focuses specifically on the complex regulations associated with federal and global regulations governing labeling, advertising and promotions. This certificate is part of the school鈥檚聽聽program and is available online. A master鈥檚 degree is not required to earn this certificate.

What is pharmaceutical labeling?

In the pharmaceutical industry, labeling is more than the prescription label or a cardboard container enclosing prescription or over-the-counter (OTC) products. Labeling is also the prescribing information (PI), which is a detailed and complicated product reference sheet 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.听This includes the following.听

• A description of the drug dosage form and its physical properties聽聽

• A listing of active ingredients and excipients聽

• The molecular structure of each compound

• The pharmacokinetics and toxicology of the drug聽

• The intended patient population聽聽

• Potential side effects and safety concerns

• Unique storage requirements聽

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.听

Why study pharmaceutical labeling and advertising in the RAQA graduate program at 51动漫?

Federal regulations also govern how prescription products can be advertised. Each year, pharmaceutical companies spend billions nationally聽on direct-to-consumer聽TV ads, which have made many products household names. The complexity of creating these ad campaigns聽while complying with federal regulations聽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聽advertising, websites about pharmaceutical products have grown exponentially, particularly those that focus exclusively on one product, serving as a聽鈥減atient reference page.鈥� In some cases, innovator companies even sell products directly to consumers聽from websites.听听

Countries often have unique regulatory requirements for labeling and advertising. For instance, some require pharmaceutical 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.听听

As the types and global reach of product advertising continue to expand鈥攖hereby crossing the boundaries of regulatory authorities and patient populations鈥攖he need for more global regulatory oversight of the labeling process聽is increasing. Recruiters from placement firms frequently call 51动漫鈥檚 RA and QA office, seeking candidates with a demonstrated knowledge of the regulations governing advertising and labeling.听听

The Certificate in Pharmaceutical Labeling, Advertising聽and Promotions provides students with credentials from 51动漫鈥檚 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.听

Learning Objectives聽

Upon completion of the Labeling, Advertising and Promotions Certificate, students will be able to聽聽

• understand U.S. and global regulatory and industry requirements for creating, updating or maintaining product labeling;聽聽

• 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;聽聽

• evaluate specific advertising and promotion communications for regulatory compliance; and

• identify the latest trends and issues posed by internet advertisements and product websites.听

Post-master鈥檚 Certificate

Students have the option to complete a post-master鈥檚 curriculum in pharmaceutical labeling, advertising and promotions. To apply for this 12-credit program, applicants must hold a master鈥檚 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鈥檚 degree from 51动漫鈥檚 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鈥檚 certificate.

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Program Format & Curriculum

The Pharmaceutical Labeling, Advertising聽and Promotions Certificate may be earned on its own or on the way to the MS in RA and QA.听听

To earn the certificate, the following four courses must be completed within a three-year period with an overall B (3.0) average.听听

• Food and Drug Law (5592)聽聽

• Requirements for Product Labeling and Advertising (5533)聽聽

• Global Labeling Regulation: Principles and Practices (5532)聽聽

• Regulation of Advertising and Labeling (5611)聽聽

Students should take Food and Drug Law before pursuing other courses in the certificate. It is suggested that Requirements in Product Labeling and Advertising be completed next. The remaining courses may be taken in any order.听听

All courses must be completed from 51动漫鈥檚 RA and QA graduate program. No transfer credits from other institutions are accepted. If a student has completed an identical course at an accredited U.S. graduate school, the student may petition the RA and QA program to waive that course and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate.听

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搁别辩耻颈谤别尘别苍迟蝉听

• Candidates must formally apply after completing courses,聽and follow the application procedures聽(application form, photocopies of transcripts and Notice of Completion).

• Only one certificate program may be completed before students receive the MS.

• The certificate must be completed within three years. Students must apply for the certificate no more than one year after completing the course requirements.听

• Students interested in pursuing the RA and QA MS degree may apply all credits earned in the Pharmaceutical Labeling, Advertising聽and Promotions Certificate toward their graduate degree, provided they formally apply for admission to the MS program and are accepted by 51动漫鈥檚 .听

Learn more about the application process.

Related Graduate Degrees

• Regulatory Affairs and Quality Assurance MS