Madhu Baswa
Intern @Renovare Healthcare Solutions
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WORK HISTORY
Intern @Renovare Healthcare Solutions
IN
EDUCATION
Rajiv Gandhi University of Health Sciences
M Pharmacy, Industrial Pharmacy
Bapuji Pharmacy College
Bachelor of Pharmacy, Pharmacy
ABOUT MADHU BASWA
Motivated and detail oriented M pharmacy graduate complemented by advanced certificate course in clinical research, Pharmacovigilance, clinical data management, regulatory affairs, medical writting.Basic knowledge on Clinical research - Drug discovery, preclinical trials, clinical trials, Good clinical practice (GCP), ethical guidelines, eCTD modules, clinical study designs, centralized and decentralised trials.Pharmacovigilance - PV overview, responsibilities, AE, abuse, misuse, medication error, off- label, Sulphanamide tragedy, Thalidomide tragedy, Causality assessment scales,(reporting system -MedWatch, yellow card, blue card),(Aggregate report - DSUR, PSUR, PADER, PBRER),(medical coding dictionaries- MedDRA)Regulatory affairs -RA overview and responsibilities, Drug Master File(DMF), Dossier, Regulatory bodies, Regulatory compliance, Regulatory submission
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