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- Certificate Course in Pharma Regulatory Affairs
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Certificate Course in Pharma Regulatory Affairs
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The total revolution of biological and chemical sciences has resulted into new concepts in pharmaceutical sciences giving rise to importance of regulations for the new products. The pharma regulatory affains are important for the knowledge of the laws and regulations mandated by the federal government, especially those of the Food and Drug Administration (FDA), as they apply to the development, testing, approval, manufacturing, commercialization and postmarking surveillance of pharmaceutical, biopharmaceutical and medical device products. This program is intended to provide students with a basic
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understanding of the areas of regulatory affairs and quality operations to give students a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.
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Aim and Objectives
The online program aims to prepare aspirants for regulatory affairs positions in
the pharmaceutical, biopharmaceutical and medical device industries and to equip
them with the educational foundation that will help them advance in the
regulatory affairs profession. The course will provide the student with the
fundamentals required in both regulatory affairs and quality operations. The
course has been framed with the following aims:
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To decipher a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.
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To prepare students for regulatory affairs positions in the pharmaceutical, biopharmaceutical and medical device industries.
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To equip participants with the educational foundation that will help them advance in the regulatory affairs profession.
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The number of career opportunities continues to grow in this field. As regulatory processes increase in complexity and scope, and globalization occurs within the field, there will be continuing industry demand for people with a strong foundation in regulatory affairs. The students of the program will have an understanding of the regulatory processes involved in biotechnology, medical device, pharmaceutical and food products. Students will become eligible for occupations involving drug or medical device submissions and quality assurance functions and roles. The individuals who are interested in pursuing a career in regulatory affairs would get a thorough understanding of current regulations and their application to the development and commercialization of drug, biologic and biodevice products. The Regulatory Affairs program provides professionals with the specialized knowledge required to help biotechnology, medical device, pharmaceutical and food companies manage regulatory processes.
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understanding of the areas of regulatory affairs and quality operations to give students a thorough and up-to date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.
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Course Modules
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