This course is designed to impart the knowledge on the regulatory requirements for approval of new drugs, drug products, medical devices, biological, biosimilar, in regulated countries like US, EU, Japan, Australia, UK etc. It prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products in regulated countries.
Dr. Charmy Kothari, Assistant Professor
Department of Pharmaceutical Analysis
Institute of Pharmacy, Nirma University.
Dr. Charmy S. Kothari has 10.7 years of teaching and research experience. She has 18 researches papers and review articles published in reputed Indian and International journals. She has presented various posters and a paper at international, national and state level conferences like GUJCOST, IPC, APA etc, from which one paper awarded 2nd prize for best oral presentation in state level conference Supported by GUJCOST in 2004 and She is also recipient of Dr. P. D. Sethi’s research paper certificate of merit award 2007 for the paper published in J of AOAC International. She was awarded first and second prize for best poster presentation in International conference on Applied Pharmaceutical Analysis, organized by Boston Society in the year 2014 and 2015, respectively. She has been actively involved in various capacities in organizing National and International Conferences/Workshops. She received a financial assistance from GUJCOST worth Rs. 40,000/- to organize workshop on Process Spectroscopy & Chromatography in department of Pharmaceutical Analysis. She is life member of APTI, IPA & ISTE. She is a recognized Post Graduate and Ph. D. Guide at Institute of Pharmacy, Nirma University. She has guided 15 M.Pharm students and currently guiding three Ph.D. Students. She received a minor research grants from Nirma University worth Rs.90,000/- in the year 2013 and GUJCOST worth Rs./- 5,00,000 in the year 2014. She is reviewer of national & international journal in her research area of interest. Her research areas of interest are analytical and Bioanalytical method development by DOE approach, validation and stability studies, impurity profiling and Isolation, identification and characterization of marker compounds from plants and formulations. Updates of Different regulatory Guidelines for regulatory affairs.
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