IBRI Noida has been providing industry oriented certificate/diploma program in Drug Regulatory Affairs. Visit us on www.ibri.org.in

1. (Department of Applied Pharmaceuticals)
Indian Biosciences and Research Institute
IBRI NOIDA

2.  India is now among the top five pharmaceutical
emerging markets.
 The Indian Pharma industry has been growing at a
compounded annual growth rate (CAGR) of more
than 15% over the last five years and has significant
growth opportunities.
 The Ministry of Commerce has targeted Indian Pharma
sector exports at US$ 25 billion by 2014 at an annual
growth rate of 25 per cent.
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3.  FDI, up to 100 per cent, under the automatic route,
would continue to be permitted for Greenfield
investments in the Pharmaceuticals sector.
 In order to encourage production of drugs by
indigenous industries, the 12th Five Year Plan (2012-17)
has recommended capacity building of private sector to
meet WHO-GMP standards and other international
manufacturing standards.
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4.  A regular student of Pharmacy B.Pharma, M.Pharma.
 A working professional in Pharmaceutical Industry.
 Research scholars' in the same domain.
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5.  12 months comprehensive course in distance mode
learning pattern.
 6 months advanced course in distance mode learning
only for working professionals.
 3 months certificate course for beginners.
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6.  Most updated course material
 Course material prepared by highly experienced
professional from the globe.
 Effective learning process.
 Excellent student support for best service.
 Industry Recognized Course.
 Coast effective.
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7.  Course contains 7 Papers as
 Paper-I: Introduction to Regulatory Affairs and Profession
 Paper-II: International Licensing and Drug Regulatory Affairs
 Paper-III: Regulatory Documentation for Biologics /Medical
Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.)
 Paper-IV: Global Regulatory Compliance Systems
 Paper-V: Regulations for Clinical Trials, GMP, GLP and ICH
Guidelines
 Paper-VI: Regulatory Strategy and Quality Assurance Systems
 Paper-VII: Future of Biopharmaceuticals
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8.  Download Registration Form
 Fill it completely
 Attach your 10th and graduation mark sheet
photocopies self attested.
 Course fee can be paid by Demand Draft / At par
Cheque.
 DD or At par Cheque must be in favor of “Indian
Biosciences and Research Institute”.
 Attach all with registration form and send it to institute
address
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9.  Complete Study Material will be dispatched to your
mailing address.
 Bimonthly assignments for self assessment.
 Contact classes on the demand to clear doubts.
 Weekly conversation with faculty members.
 Examination and assessment.
 Successful candidates will received Certificate and
mark sheet.
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10.  Regulatory Affairs is a comparatively new profession which has
developed from the desire of Governments to protect public
health, by controlling the safety and efficacy of products in areas
including pharmaceuticals, veterinary medicines, medical
devices, pesticides, agrochemicals, cosmetics and
complementary medicines.
 The Regulatory Affairs professional’s job is to keep track of the
ever-changing legislation in all the regions in which the
company wishes to distribute its products. With the aim of
providing training IBRI has launched the course in Regulatory
affairs with the mission to train students and professionals who
can help the industry to work under regulatory environment.
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11.  TO KNOW MORE Click Here !
 Indian Biosciences and Research Institute
C 50, Sector 2, NOIDA 201301
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12. Indian Biosciences and Research Institute
C 50, Sector 2, NOIDA 201301
www.ibri.org.in, info@ibri.org.in
Phone: 0120-4122315
Mob: 9999509892
IBRI NOIDA