Research Article | Open Access
Volume 3 | Issue 1 | Year 2016 | Article Id. IJPBE-V3I1P101 | DOI : https://doi.org/10.14445/23942576/IJPBE-V3I1P101Regulatory Affairs and its Role in Pharmaceutical Industry
P. Praneeth
Citation :
P. Praneeth, "Regulatory Affairs and its Role in Pharmaceutical Industry," International Journal of Pharmacy and Biomedical Engineering, vol. 3, no. 1, pp. 1-2, 2016. Crossref, https://doi.org/10.14445/23942576/IJPBE-V3I1P101
Abstract
Regulatory affairs in the pharmaceutical industry play an important role as the 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 profession which acts as the interface between pharmaceutical industries and government authorities across the world. The goal of the regulatory affairs professional is the protection of human health, ensuring safety, efficacy, and quality of drugs, ensuring appropriateness and accuracy of product information. This present article discusses the evolution of Regulatory Affairs, its role in the pharmaceutical industry and its involvement for the implementation of regulatory guidelines which improve the growth of the industry.
Keywords
Regulatory Affairs, Pharmaceutical industries, world regulatory bodies.
References
[1] Regulatory affairs from Wikipedia, the free encyclopaedia modified on 21 st January available at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
[2] Douglas J Pisano and David S. Mantus. “Text book of FDA Regulatory Affairs- A Guide for Prescription Drugs, Medical Devices, and Biologics” Second Edition.
[3] www.centerwatch.com
[4] www.regulatoryone.com
[5] Sachin C Itkar, Dr. Ns Vyawahare, “Drug Regulatory Affairs”, Third edition (2015).
[6] “Need For the Introduction of Regulatory Affairs in the Pharmacy Curriculum” Health Administrator Vol: XIX Number 1: 51-52
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Abstract
Keywords
References