Current Scenario of Regulatory Affairs In Pharmaceutical Education Sector -A review

Authors

  • Ms Shelly Senior Manager,Department of Regulatory Affairs,PharmHawk Consultant, New Delhi(110018), India;

Keywords:

Regulatory affairs, Pharmaceutical industries, Pharmacy College

Abstract

Indian pharmaceutical sector is rising very rapidly and there is a want of regulatory affairs professionals to provide the current needs of industries for the global competition. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. The areas where government controlling the safety and efficacy of products are pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The pharmaceutical companies responsible for the discovery, testing, clinical trials, production, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. They are required to be well versed in the laws, regulations, guidelines and guidance of the regulatory agencies. There is a growing need to incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the students with the latest developments to serve the industries. The present article discusses the regulatory education and its need, learning resources, courses available, syllabus contents, and job opportunities in regulatory affairs

References

Quality Assurance of Pharmaceuticals. A compendium of guidelines and related materials. Good manufacturing practices and inspection, Volume 2 (updated version). Geneva, World Health Organization, 2004.

Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products – A Manual for a Drug Regulatory Authority. Geneva, World Health Organization, 1999 (Regulatory Support Series, No. 5, WHO/DMP/RGS/98.5).

A Model Quality Assurance System for Prequalification, Procurement, Storage and Distribution of Pharmaceutical Products. Geneva, World Health Organization, 2003 (unpublished draft).

Managing Drug Supply. The selection, procurement, distribution, and use of pharmaceuticals. Management Sciences for Health in collaboration with World Health Organization. 2nd Ed. Connecticut, USA. Kumarian Press, Inc., 1997.

Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C63/03). European Agency for Evaluation of Medicinal Products. Directive 92/25/EEC of 31 March 1992.

Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use. Therapeutic Goods Administration, Australia. November 1991.

Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of drugs and Current Good Manufacturing Practice for Finished Pharmaceuticals. Code of Federal Regulations Parts 210 and 211. Food and Drug Administration, USA.

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Published

2017-12-30

How to Cite

Ms Shelly. (2017). Current Scenario of Regulatory Affairs In Pharmaceutical Education Sector -A review. Innovative Research Thoughts, 3(9), 145–154. Retrieved from https://irt.shodhsagar.com/index.php/j/article/view/246