Drug Regulatory Affairs


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Drug Regulatory Affairs program in distance mode education at IBRI NOIDA.

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Drug Regulatory Affairs

  1. 1. (Department of Applied Pharmaceuticals) Indian Biosciences and Research Institute IBRI NOIDA
  2. 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. IBRI NOIDA
  3. 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. IBRI NOIDA
  4. 4.  A regular student of Pharmacy B.Pharma, M.Pharma.  A working professional in Pharmaceutical Industry.  Research scholars' in the same domain. IBRI NOIDA
  5. 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. IBRI NOIDA
  6. 6.  Most updated course material  Course material prepared by highly experienced professional.  Effective learning process.  Excellent Support Department for best service.  Industry Recognized Course.  Coast effective. IBRI NOIDA
  7. 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 IBRI NOIDA
  8. 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 IBRI NOIDA
  9. 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. IBRI NOIDA
  10. 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. IBRI NOIDA
  11. 11.  TO KNOW MORE Click Here !  Indian Biosciences and Research Institute C 50, Sector 2, NOIDA 201301 IBRI NOIDA
  12. 12. Indian Biosciences and Research Institute C 50, Sector 2, NOIDA 201301 www.ibri.org.in, info@ibri.org.in Phone: 0120-4122315/ 6513155 Mob: 9999509892 IBRI NOIDA