PROJECT MANAGEMENT VALUES DRIVEN IN PHARMA INDUSTRY

  • Swagat Tripathy
  • Bishnu B. Mohanty

Abstract

In the pharmaceutical industry, project management is key to addressing the unique regulatory, compliance and quality related needs of the industry. As the process of drug development and the critical issue of time to market can capitalize on project management techniques to effectively apply scheduling, risk management, and comprehensive quality assurance and control to the process of bringing a drug to market in a cost-effective but safe way.


“JUST DO IT” is the approach that XYZ Generic Company was using before this project arrives.


Disclaimer statement: The writing and views expressed are those of purely of author’s personal view and is not related to the organization, where authors are working.

Keywords: RA, AO, QA, RLD, R&D,PM, FDA, API, FTF.

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References

1. US Food and Drugs Administration [Internet].United States: Food and Drugs Administration; 2015 [cited 2015 Oct 04].Available from:
http://www.fda.gov/Drugs/
2. US Food and Drugs Administration [Internet].United States: Food and Drugs Administration; 2015 [cited 2015 Oct 09].Available from:
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM447307.pdf
3. US Food and Drugs Administration [Internet].United States: Food and Drugs Administration; 2015 [cited 2015 Oct 07].Available from:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm
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How to Cite
Tripathy, S., and B. B. Mohanty. “PROJECT MANAGEMENT VALUES DRIVEN IN PHARMA INDUSTRY”. International Journal of Drug Regulatory Affairs, Vol. 4, no. 2, Feb. 2018, pp. 27-32, doi:10.22270/ijdra.v4i2.183.