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Medical Device Research and Development:
Concept to Commercialization with Case Studies

Dr. PV. Mohanan, Scientist & Head, Toxicology Division, Sree Chitra Tirunal Institute for Medical Sciences and Technology (Govt. of India), Biomedical Technology Wing, Poojapura, Thiruvananthapuram – 695012, Kerala.

Dr. Mohanan dis his PhD in ‘Toxicological / Safety evaluation of anticancer drug’ and Postdoctoral programme in toxicology at the Institute of Community Medicine, The University of Tsukuba, Japan.

He has 23 years experience in Pre-clinical toxicity / safety evaluation of medical devices, drugs, chemicals and tissue engineered products as per OECD, ASTM, USP, FDA, ISO protocols.

Dr. PV. Mohanan
Scientist & Head
Toxicology Division
Sree Chitra Tirunal Institute
for Medical Sciences & Technology (SCTIMST)

He is a National GLP Inspector, participated in more than 23 GLP inspection in industry, Institute, CROs and Pharma companies both in India and abroad. Participated as a GLP Inspector during the Mutual Joint Visit by OECD GLP team, participated as an observer at the International GLP Inspection held at Switzerland and France.

Faculty member at the training cum Refresher Course for GLP Inspectors and training course on Test facilities conducted by National GLP Compliance Monitoring Authority, Dept. of Science and Technology, New Delhi.

He has participated at the training on ‘Non-clinical safety testing of products’ organized by TDS of WHO (2005) and GLP Trainers trainee course (WHO, 2003) at New Delhi.

Presently, he is the Secretary-General of the Society of Toxicology India and General Assembly Councilor at the International Union of Toxicology, USA. He is a Fellow of Society of Toxicology, India, Fellow of Academy of Sciences for animal welfare,, recipient of prestigious JSPS award from Japan Society for the Promotion Sciences, Govt. Japan and STOX/ASAW – Surajben Jethalal Thaker Prakruti Mandir Gold medal award.

Dr. Mohanan is member of many professional bodies / societies related to Toxicology / Quality Assurance / Animal Welfare. He has 73 publications in National and International Journals and edited two books in GLP area.