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.

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 BII
Established 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.

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 Modules
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

6. About Course
Program
Eligibility Fee Exam Fee
Any Rs. 10,300/- Rs. 300/-
(Overseas
Science per
students : 750
Graduate USD) module

7. Career in PRAF
Pharma Regulatory Affairs Consultant
Regulatory 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.