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Thursday, 13 December 2018

Guest Lecture on “Drug Regulatory Affairs: Pharmaceutical Industry” - NGSMIPS

A guest lecture on the topic “Drug Regulatory Affairs: Pharmaceutical Industry” was organized by the Department of Pharmaceutics, Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences, Mangaluru on 8th December 2018. Mr. Manoj Kumar Singh Chauhan, Manager, RA & QA, PharmaLeaf, Bangalore was the invited speaker. Prof. Dr. R Narayana Charyulu, Head,Department of Pharmaceutics welcomed the guests. He introduced the guest speaker and briefed on the importance of the session. The resource person, Mr. Manoj Kumar discussed about various practices in the Drug Regulatory Affairs and gave key insights on the latest updates. He explained about various types of documentations necessary for the registration and marketing approval of a drug. He also threw light upon some the differences between Indian drug regulatory authority CDSCO and various drug regulatory authorities around the world like USFDA, MHRA and EMA. This session was mainly aimed at making the M. Pharm students at par with the latest advancements in the drug regulatory affairs.


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