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Thursday, 23 March 2017

One day national seminar on drug regulatory affairs, March 11, 2017 - NGSMIPS.

A One day National Seminar on “Drug Regulatory Affairs: An Industrial Perspective” was organized by the Departments of Pharmaceutics and Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University on March 11, 2017 at the K.S.Hegde Medical Academy, Derelakatte.

In a brief ceremony in the morning, the seminar was inaugurated by the Chief Guest, Dr.Shenaz Z. Khaleeli, Co-Founder and Technical Director of Pharma Leaf India Pvt. Ltd., Bengaluru.

Prof. (Dr.) Iddya Karunasagar Senior Director, International Relations, Technology Transfer & Patents, Nitte University was the Guest of Honour.

Dr. R. Narayana Charyulu, Vice Principal and HOD, Dept. of Pharmaceutics welcomed the dignitaries and the gathering and highlighted the significance of this seminar. He said that the need for ensuring the availability of safe and efficacious drug products has given rise to a new profession in the pharma industry, that of Drug Regulatory Affairs.

In his address, Dr. C.S. Shastry, Principal informed the gathering that there is a growing demand for professionals trained in the area of Drug Regulatory Affairs and therefore this seminar would be valuable for those aspiring to work in this field.

In her address, Dr.Shenaz Khaleeli spoke of how Regulatory Affairs can be exciting career for a graduate pharmacist. She said that it creates a balance between Pharmaceutical Industry and career in technical project management as well as in the marketing.

The Scientific sessions that followed had six speakers from the pharma industry such as Mylan Labs, Novartis, PharmaLeaf, IMED Global, Reliance Life Sciences and from the academics such as Manipal University who delivered lectures on various topics related to Drug Regulatory Affairs, Intellectual Property Rights and Pharmaceutical marketing. In her lecture, Dr.Shenaz Khaleeli spoke of how Regulatory Affairs can bean exciting career for a graduate pharmacist. She said that it creates a balance between Pharmaceutical Industry and career in technical project management as well as in the marketing. Mr. Srivatsa Rao, Associate Director, Regulatory Operation, EMEA, IMED Global Solutions India Pvt. Ltd., Bengaluru spoke on, “Pharmaceutical Industrial Market: An Incursion” Mr. Devraj Shetty, DGM-Quality, Reliance Life Sciences, Mumbai delivered a lecture on, “Quality and Regulatory: An Industrial Perspective” The lecture delivered by Dr. Srikanth Nadig, DGM – Analytical R&D, Mylan Laboratories Ltd., Hyderabad highlighted analytical knowledge and its impact on good Regulatory Affairs. Dr.Subrahmanyam Ganeshan, Senior Scientist, Novartis, Hyderabad spoke briefly onthe importance of using modeling approaches in drug development to overcome challenges in characterizing drug safety and efficacy under the current drug development paradigm is highlighted by Health agencies. Dr.Manthan D. Janodia, an Associate Professor and Coordinator, Technology Transfer Office, Manipal College of Pharmaceutical Sciences discoursed about the differences between Drug Regulatory Affairs and Intellectual Property Rights. The seminar was attended by 258 delegates from colleges in and around Mangalore of whom 16 were from faculty and 242 from students. Among the student delegates, 148 registrations were from NGSMIPS and 94 from other institutions. Feedback obtained from the delegates revealed excellent ratings with respect to information gained from the lectures as well as for the location and facilities provided. As a whole there was a favourable response towards the answers from queries put to the resource persons and clarity of the presentations






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