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Mr. Nitin Chandurkar

General Manager
Clinical Research and Development, Ipca Laboratories Ltd
 

Brief Biography:


Clinical Research professional with over 14 years of experience in Clinical Drug Development, Regulatory Affairs, Clinical Quality Assurance, Publication, Patents and Intellectual Property Rights Management in Pharmaceutical industry The wealth of expertise entails Study Conceptualization, Designing, Medical Writing, Clinical Data Management, Medico-Regulatory Affairs, Regulatory Queries Handling, and Clinical Trial Project Management In-depth understanding of quality standards and regulatory requirements for conducting Bioequivalence Studies, Phase I to Phase IV Clinical Trials including NCE Development Programs. Possess qualitative experience in Writing Protocols / Manuscripts, Data Validation Plan, Designing Case Report Form, and Clinical Trial Monitoring Adept at conducting feasibility studies for new studies, site evaluation and maintaining source data verification; deft at handling clinical development activities for Ayurvedic, Biotech Products and Vaccines besides Synthetic Drugs Worked with leading pharmaceutical companies like Dr Reddys Laboratories Ltd, Dabur Research Foundation, and Ipca Laboratories Ltd and academic institutions like Indian Institute of Science, Bangalore, National Institute of Malaria Research , New Delhi, Jawaharlal Nehru University, New Delhi, Central Drug Research Institute, Lucknow, PGIMER, Chandigarh, Department of Biotechnology, New Delhi and more than 90 premier teaching hospitals run by Government and Private administrative bodies all over India. Holds the distinction of publishing over 40 studies in International Peered Review Journals with a good impact factor and co reviewed manuscripts for various international journals Experience in various therapeutic areas like hypertension, diabetes, nephropathy, dyslipidemia, osteoarthritis, rheumatoid arthritis, pain management, respiratory tract infections, surgical prophylaxis, panic disorder, malaria, cancer, hepatitis B, gastric and duodenal ulcers, anemia, migraine, allergic rhinitis, deep vein thrombosis etc Meticulously contributed in carrying out: Over 75 clinical studies and around 160 bioequivalence studies for various regulatory authorities such as USFDA, EU, TGA, Medsafe, ANVISA, Health Canada, WHO, Mexico, etc. Received favorable editorial from an independent reviewer based on our work published in international journals

 

Academic positions:


NIL

 

Research interests:


Clinical Research

 

What I think of the idea behind WebmedCentral:


Such initiative will bring the scientific reseach professionals togeather,it will provide a good platform for cross fertilization of Ideas across the globe.