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A guest lecture on ‘Industrial Perspective on Regulatory and Safety Toxicology and its importance’ was organized by the department of Pharmacology on 7^th January 2023. The speaker of the hour was Dr. Sebastian V Joseph, principal consultant, Director – Development consulting and Scientific Affairs, PharmLex India Pvt. Ltd, Noida. This lecture was attended by the faculty and postgraduate students of the Department of Pharmacology, and BPharm 8^th semester students.

The talk began with a brief introduction of Dr. Sebastian followed by his interaction with the students. He urged students to study the subject strategically not only for exams but also as preparation for job interviews. He started with an outline of the organization of a pharmaceutical company and various job opportunities in the field of pharmacology and toxicology. Thereafter, he briefed his role as a consultant in the pharma sector.

Dr. Sebastian gave a brief overview of the regulatory requirements involved in developing a new drug and the 3 key points for a new drug dossier – efficacy, quality, and safety. He highlighted the scope of toxicological studies and explained basic terminologies such as NOAEL, LOAEL, MTD, and MLD in a simple way. He explained risk assessment in detail with an example of a case he dealt with. The 4 steps involved in risk assessment were also explained i.e., hazard assessment, exposure limit derivation, exposure assessment, and risk characterization. He gave several insights into the importance of toxicological studies. Then towards the end of the lecture, the speaker gave an outline of GLP and the 2 main GLP standards used across the globe – 21 CFR part 58 and OECD GLP.

Dr. Sebastian concluded the lecture with the enormous scope of toxicology in the pharmaceutical sector and suggested a few tips to the students on how to prepare for the exam as well as an interview.?

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