pharma regulatory affairs
DESCRIPTION
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 : [email protected], 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.TRANSCRIPT
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
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.
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.
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.
2
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
About Course
Eligibility
Any Science
Graduate
Program Fee
Rs. 10,300/- (Overseas
students : 750 USD)
Exam Fee
Rs. 300/- per
module
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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