Hema Gupta, MSc, PhD, CCM
Ottawa, ON
Medical Microbiologist
Ottawa, ON
CWHHA member since 2022.
Biography
I received doctoral degree in biomedical sciences and Canadian board certification in medical microbiology. I had undertaken Pathobiology courses with University of Toronto. I have an extensive knowledge in Medicine, Biostatistics, Pharmacology, Pathobiology and Toxicology that is required for evaluation of new drug’s efficacy and safety assessments. I have undertaken advanced course on Med DRA coding and Standard Med DRA Queries (SMQs) and have been utilizing gained knowledge in day-to-day assignments. I have undertaken advanced courses in Monte Carlo simulations, pharmaco-epidemiology, and pharmacovigilance. I participate regularly in Canadian hospitals, national and international conferences and platforms regularly and share knowledge gained with colleagues and management on various issues.
I have received many awards from the Associate Deputy Health Minister and Director General of Therapeutic Drug Directorate of Health Canada (HC); a national award from India on “achievement in liver diseases” and numerous appreciation letters from stakeholders (industry and physicians) for professionalism, courtesy, with overall emphasis on sound science and quality responses during regular and Covid -19 pandemic related queries. I am an active executive voluntary member of visible minority network/disability and manager’s network.
I have worked in Canada, United States, Japan and India right from clinical diseases, laboratory management, and differential diagnosis. Currently, I have been critically assessing safety and efficacy data for authorization of sale of new anti-infectious and cancer drugs and in vitro devices and provide advice on risk mitigation strategies based upon evidence-based assessments to HC. I have excellent communication and negotiation skills with experts of pharmaceutical companies that have placed me on client service excellent list. I have provided support on request for various management assignments and special projects (Canada’s response to antimicrobial resistance action (AMR) Plan; ICH guidance’s’ developments (ICHE11 (pediatrics), ICH E14 (QT-QTc prolongation); HC’s safety and efficacy data review requirements and labelling). I work in a multidisciplinary HC and health technologies team with medical experts and provide scientific advice to stakeholders prior to the submission phase. This work contributed enormously to setting HC as a credible international collaborator with other regulatory agencies. I worked in project Orbis for an international (USA-Canada-Australia-Swiss Medic-Singapore) joint drug regulatory review on drugs of unmet need.
I have taught pathobiology and infectious diseases to graduate students in the Pathology, Microbiology and Public Health at the National University of Health Sciences, Illinois and with the industry for development of point of care rapid molecular diagnostic tests. After 2000, I worked for four years in six major hospital’s microbiology laboratory (bacteriology and virology benches) and in provincial health laboratory-serving children, geriatric, transplant, AIDS, MTB and homeless population at risk of various infections. From 1984-2000, I managed a hospital laboratory, and reported on diagnostic, confirmatory and disease progression tests to the health care professionals. I developed tests for new hepatitis viruses (C & E) in a WHO project “surveillance of viral hepatitis in India”. I am a pioneer in discovery of hepatitis C & E viruses. After immigrating to Canada in 1991, I worked on hepatitis and AIDS laboratories in University of Toronto and Canadian Red Cross.
