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Post Graduate Diploma In Pharmaceutical regulatory Affairs (PGDPRA)
(Minimum One Year and Maximum Two Years)


Program Objectives


The major objective of this course is to provide an interdisciplinary knowledge of pharmacy and law as applicable in the field of pharmaceutical regulation at National and International levels. The course prepares the students to pursue career in pharmaceutical industry, drug licensing and control authorities, and export-import agencies dealing with the pharmaceuticals.


Program Eligibility


A candidate seeking admission to the above programme must have passed bachelor degree in pharmacy or medical sciences. A candidate having bachelor Degree in any discipline with two years of experiences in Pharma industry will also be eligible. No age bar.


Fee Structure : Course Fee Rs. 20,000 (payable at the time of admission)

Examination fee Rs. 2,000/-

Identity Card Fee Rs. 100/-

Note: All fees shall be paid by the students through bank Demand Draft only, in favor of "Jamia Hamdard" , and payable at "New Delhi".


Course Content


There would be following eight papers each of 100 marks.

  • An Introduction to pharmaceutical Drug Regulatory affairs
  • General Pharmaceutical laws and Guidelines
  • Drug Regulatory Affairs in India
  • Information and Quality Management
  • Chemical, Pharmaceutical and Biological aspects of regulatory documentation
  • Clinical trials and health care policies
  • International licensing
  • Regulatory considerations in controlled drug delivery and future aspects of Biopharmaceuticals.

Admission Procedure

  • Submission of Application
  • Enclosures

MAILING ADDRESS



Bio-Informatics Institute of India
C-56A/28, Sector-62
Noida-201301
Ph. No.: 0120-4320801/802
E-mail : info@bii.in ,technical@bii.in


Sms Bii to 56070
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