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THE PHARMA REVIEW OCTOBER 2005

Need for the Introduction of Regulatory Affairs in the Pharmacy Curriculum

D. Sreedhar, G. Subramanian, M. Sreenivasa Reddy and N. Udupa*

Abstract: The pharmaceutical, biotechnology and medical device research and development industries are among the most highly regulated industries in the country. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and world wide regulatory agencies. They are required to be well versed in the laws, regulations, guidelines and guidances 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.

 
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