Guest Lecture Organized by ISPOR & Department of Pharmaceutical Regulatory Affairs and Management, MCOPS
August 16, 2023
A Guest lecture was jointly organized by ISPOR Manipal Student Chapter and the Department of Pharmaceutical Regulatory Affairs and Management, MCOPS on 16 August 2023. Speakers were Mr Vikas Johri (Vice President, Global Regulatory Affairs, Glenmark Pharmaceuticals Ltd.) and Mr Ankur Shah (Deputy General Manager, Global Regulatory Affairs, Glenmark Pharmaceuticals Ltd.). A short introduction was provided on how regulatory affairs operate in the pharmaceutical industry.
A short introduction was provided on how regulatory affairs operate in the pharmaceutical industry. Global regulatory affairs in pharmacy is a specialized area that focuses on navigating the complex landscape of regulations and guidelines governing pharmaceutical products internationally. It is considered the "rulebook" that companies must follow to ensure their drugs are safe, effective, and legal worldwide. These regulations are transcribed based on the safety and effectiveness of drugs according to the FDA in a book called "The Publication Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly called "The Orange Book". Experts working in regulatory affairs understand and follow the set of rules presented by different countries so that they can produce good-quality drugs that people can consume anywhere in the world. It was elucidated that the statutes vary depending on the type of market they target. Two types of markets exist: regulated and semi-regulated. The significant difference is in the implementation of the regulations and the intensity of the audits conducted.
The presentation was well-received by the attendees, who appreciated the opportunity to expand their understanding of the subject matter.
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