Basic Pharmaceutical Development Certificate

The Basic Pharmaceutical Development Certificate in the at 51¶¯Âþ combines a general overview of the drug development process with pharmaceutical industry business practices. This pre-master’sÌýcertificate enables students to explore quality assurance and regulatory affairs in pharmaceutical development as a prospective career path without committing to a master of science degree. Students in the program are exposed to the specialized language of the industry, the overriding concern for imbuing quality in the industry and the regulations that directly impact industry business decisions.ÌýThis certificate is part of the School of Pharmacy’sÌý.Ìý

51¶¯Âþ recognizes that professionals with business and nonscience degrees may wish to enter or advance their careers in the pharmaceutical industry but need specialized training in its terminology, conceptsÌýand regulatory milieu. Whether they are just entering the workforce or looking for ways to advance in a global corporation, they will benefit from a deeper understanding of how pharmaceutical products are discovered, manufactured and distributed. They will also develop a greater familiarity with the multitude of federal and international regulations governing every aspect of product quality.ÌýÌý

This certificate may be completed in person or can be pursued entirely online.

Regulatory Affairs and Quality Assurance at the School of PharmacyÌý

For over five decades, 51¶¯Âþ’s has provided outstanding graduate-level coursework in . Regulatory affairs and quality assurance are the practices through which professionals ensure that products comply with government regulations and meet industry standards.

The School of Pharmacy Ìý

  • pioneered RA and QA graduate education in 1968, offered the first RA and QA online degree program and offers the most comprehensive RA and QA curriculum;ÌýÌýÌý

  • has outstanding expert faculty from industry and the U.S. Food and Drug Administration (FDA), assuring the latest developments and practices are taught;Ìý

  • attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare);Ìý

  • schedules live courses with interactive discussions and workshops on evenings and weekends;Ìý

  • has hundreds of students from across the country, facilitating great networking opportunities; andÌý

  • provides individualized services to students.  ÌýÌý

CertificatesÌýprovideÌýcredentials from 51¶¯Âþ’s well-respected RA and QAÌýgraduate program,Ìýwhich canÌýbe applied to the RA and QA master’s degree.Ìý

Program Format & CurriculumÌýÌý

To be considered for the Certificate in Basic Pharmaceutical Development, candidates must have a degree from an accredited institution of higher learning. (A science degree is not mandatory.)Ìý

The certificate in pharmaceutical developmentÌýmay be earned on its own or on the way to the MS in RA and QA, either online or in person. The following courses must be successfully completed within a three-year period with an overall B (3.0) average.Ìý

There are two required courses.Ìý

  • Drug Development (5459)

  • Pharmaceutical Marketing (5472)

Students should start the program with Drug Development. In addition, students must select two of the following courses.Ìý

  • Pharmacoeconomics (5408)

  • IND/NDA Submissions (5495)

  • Requirements for Product Labeling & Advertising (5533)

  • Food and Drug Law (5592)

  • Project Management for Pharmaceutical Professionals (5615)

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

Students interested in pursuing the MS in RA and QA may apply all credits earned in the Basic Pharmaceutical Development Certificate toward their graduate degree, provided they formally apply for admission to the MS program and are accepted by 51¶¯Âþ’s graduate school.Ìý

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RequirementsÌý

  • Candidates must formally apply and follow the application procedures.Ìý

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

  • The certificate must be completed within three years.ÌýÌý

  • Students may apply for the certificate within one year of completing all required coursework for the program.ÌýÌý

Learn more about the application process.

Related Graduate Degrees

Tuition & Fees

In keeping with 51¶¯Âþ’s commitment to access and affordability, this program offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates at 51¶¯Âþ are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more.

You can view the full on the Student Financial Services website. You can also view the .Ìý

Accreditation

51¶¯Âþ’s departments and programs are accredited by theÌý.

PH-BPD-GRAD

Additional Program Information

Available online.