Generic Drugs Certificate

The Generic Drugs Certificate聽in the at 澳门六合彩官网 features a specialized curriculum that delves into domestic and global regulations for generic products. This certificate is part of the school鈥檚聽.听

Starting with an overview of the drug development process, courses explore the global marketplace for generic drugs, building a strong foundation in generic regulatory issues, including the abbreviated new drug application (ANDA) process. Students learn the key trends and controversies facing the generic industry as well as how generic drugs are manufactured and regulated nationally and globally. Students also cover topics such as the issues unique to generic drug manufacturers as well as regulatory issues critical for industry professionals to understand how to help companies create safe and effective bioequivalent products. 聽

The Certificate in Generic Drugs enables students to sharpen their knowledge of this industry niche without committing to the entire RA and QA master of science聽degree. 聽

Learning Objectives聽

Students completing the certificate will become familiar with the following topics.听

  • Domestic and global regulations for generic products聽

  • The competitive environment for generic products

  • Manufacturing science and quality practices

Post-master鈥檚 Certificate in Generic Drugs

Students have the option to complete a post-master鈥檚 curriculum in generic drugs. This聽post-master鈥檚 certificate聽focuses on the regulatory issues that are critical for generic industry professionals to understand if they are to ensure that their companies create safe and effective bioequivalent drugs. 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 biology, chemistry, engineering, pharmacy, physics or related fields.

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Regulatory Affairs and Quality Assurance at the School of Pharmacy聽

For over five decades, 澳门六合彩官网鈥檚 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 聽

  • 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;聽聽聽

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

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

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

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

  • provides individualized services to students.鈥�犅�

Certificates聽provide聽credentials from 澳门六合彩官网鈥檚 well-respected RA and QA聽graduate program,聽which can聽be applied to the RA and QA master鈥檚 degree.听

Program Format & Curriculum聽

To pursue the Generic Drugs Certificate, students must have a bachelor鈥檚 degree in science, such as biology, chemistry, engineering, pharmacy, physics or related fields from an accredited institution of higher learning. 聽

In addition, students need a basic knowledge of pharmaceutical manufacturing processes, such as completion of Good Manufacturing Practices (5477) or Advanced GMPs鈥攄efining 鈥渃鈥� (5479). 聽

The Certificate in Generic Drugs may be earned on its own or on the way to the MS in RA and QA. To earn the certificate, five courses must be successfully completed within a four-year period with an overall B (3.0) average. 聽

There are two required courses.听

  • Drug Development (5459)聽

  • Generic Drug Regulation: ANDAs (5473) 聽

Students must also complete three electives from the following. 聽

  • The Global Biopharmaceutical Industry (5458)聽

  • Drug Dosage Forms (5499) or Solid Dosage Forms鈥擲mall Molecules (8004)聽

  • Active Pharmaceutical Ingredients (APIs) (5513)聽

  • Good Distribution Practices (Pharmaceutics 5543)聽

  • Global Pharmaceutical Excipient Regulation (5546)聽

  • Global CMC Issues and Regulatory Dossiers (5576)聽

  • Analytical Chemistry in Pharmaceutical Laboratories (5655)聽

  • Special Topics: Current Issues Affecting the Generic Drug Industry (5650)聽

All courses must be completed from 澳门六合彩官网鈥檚 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.听

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

  • Only one certificate may be earned before students receive the MS.听

  • The Certificate in Generic Drugs must be completed within four years.听

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

  • Students interested in pursuing the RA and QA MS program may apply all credits earned from the Certificate in Generic Drugs toward their graduate degree, provided they formally apply for admission to the MS program and are accepted by 澳门六合彩官网鈥檚 .

Related Graduate Degrees

Tuition & Fees

In keeping with 澳门六合彩官网鈥檚 commitment to access and affordability, this program offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates at 澳门六合彩官网 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 .听

Accreditation

澳门六合彩官网鈥檚 departments and programs are accredited by the聽.

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Additional Program Information

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