Pharma Regulatory Affairs

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The course has been framed with the following objectives …

The course has been framed with the following objectives
Career Opportunities

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. The course would facilitate the participants with the understanding of th e 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.

Pharma Regulatory Affairs Consultant
Regulatory Officer


For further details and enquiries
Call:0120-4320801/02
Mob:09810535368,9818473366
E-mail : info@bii.in,
www.bii.in
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. BIOINFORMATICS INSTITUTE OF INDIA C-56A/28, Sector - 62, Noida - 201 301 (U.P) (INDIA) Call : 0120-4320801/02 Mobile : 09818473366,09810535368 E-mail : info@bii.in
  • 2. About BIIEstablished in 2002, Bioinformatics Institute of India (BII) is firstof its kind with solely focusing on Bioinformatics and otherapplied life sciences domains. BII is registered under ConfrereEducational Society. The society is formed by academicians,scientists and engineers. The society is registered since 2002under Societies Registration Act in Meerut.
  • 3. 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.
  • 4. 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.2 • 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.
  • 5. Course Modules1、Pharma Regulation Practices and Procedure2、Pharma Patents, IPR and Regulation3、Pharma Regulatory Regime in USA ,EU and India4、Clinical Trial and Regulation5、Good Manufacturing Practices, Quality Assurance and Regulation6、Regulatory Compliance for Pharma and Biotech Products7、 Research Study
  • 6. About Course ProgramEligibility Fee Exam Fee Any Rs. 10,300/- Rs. 300/- (Overseas Science per students : 750 Graduate USD) module
  • 7. Career in PRAFPharma 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.