Pharma Regulatory Affairs
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Transcript of Pharma Regulatory Affairs
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BIOINFORMATICS INSTITUTE OF INDIAC-56A/28, Sector - 62,
Noida - 201 301 (U.P) (INDIA)Call : 0120-4320801/02
Mobile : 09818473366,09810535368E-mail : [email protected]
PRAF
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About BIIEstablished in 2002, Bioinformatics Institute of India (BII) is first of its kind with solely focusing on Bioinformatics and other applied life sciences domains. BII is registered under Confrere Educational Society. The society is formed by academicians, scientists and engineers. The society is registered since 2002 under Societies Registration Act in Meerut.
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Pharma Regulatory Affairs
• The industry program aims to prepare aspirants for regulatory affairs positions in the pharmaceutical, biopharmaceutical and medical device industries i.e. 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.
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1 Objective of Programs
• 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.
• To create experts in the field of RA documentation and research
• To help students build their career in RA and become RA professionals.
• To provide students with a global knowledge of Regulatory Affairs.
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1 、 Pharma Regulation Practices and Procedure
2 、 Pharma Patents, IPR and Regulation
3 、 Pharma Regulatory Regime in USA ,EU and India
4 、 Clinical Trial and Regulation
5 、 Good Manufacturing Practices, Quality Assurance and Regulation
6 、 Regulatory Compliance for Pharma and Biotech Products
7 、 Research Study
Course Modules
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About Course
Eligibility
Any Science
Graduate
Program Fee
Rs. 10,300/- (Overseas
students : 750 USD)
Exam Fee
Rs. 300/- per
module
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Career in PRAF
Pharma Regulatory Affairs ConsultantRegulatory Officer
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.
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THANK YOU!