Doctor's Profile

Dr. Shoma Mukherjee

M.B.B.S, M.D

Assistant professor, Department of Pharmacology

Reg. Number: DMC-2276

drshoma.mukherjee@gmail.com

About

A professional in the field of pharmacology with more than 14 years of cumulative research and teaching experience, been the functional In-charge of the Clinical Pharmacology Unit acting as a Manager & Principal Investigator for Bioequivalence/Bioavailability studies. Conducted > 500 healthy volunteers & a Phase 1 study (BA/BE) as Principal Investigator in the capacity of Senior Research Scientist. Handled ~15 multicenter Clinical Trials (Phase II – IV) as Medical Monitor & Therapeutic Area Specialist. Facilitated audits by various regulatory bodies (US FDA, WHO, MHRA, THAI FDA, ANVISA etc.).

Co – supervisor for a PhD Research Scholar in Pharmaceutical Medicine and 2 M. Pharm Research Scholar. More than 9 years in academics, currently I am co- supervisor of 1 M.D & 1 PhD Pharmacology student.

Area of Interest

  • Therapeutic Drug Monitoring & Pharmacovigilance of Drugs & Medical Device.

Educational Qualifications

Degree Year Name of College & University Registration Number Date of Registration
M.D Pharmacology 2005 Gauhati Medical College & Hospital, University Of Gauhati, Assam DMC-1245 19-12-2016
M.B.B.S 1997 Silchar Medical College & Hospital, Assam University DMC-1245 19-12-2016

Deatils of Teaching Experience

Designation* Institution From To Duration
Assistant Professor HIMSR, New Delhi 31-01-2017 Till date 4 Years 3 months
Assistant Professor Rama Medical College & Research Centre 16-09-2011 09-01-2012 4 Months
Tutor HIMSR, New Delhi 13-03-2015 30-01-2017 1 Year 10 months
Senior Resident Lady Hardinge Medical College 03-08-2007 30-09-2007 2 Months
Senior Resident Institute of Human Behaviour & Allied Sciences 02-11-2005 03-05-2007 2 Years 10 months
Junior Resident Gauhati Medical College & Hospital 12-06-2002 13-06-2005 3 Years

Publications

Research Work & Projects

  • ICMR Funded Research Project Technically Approved- July 2020 titled “A Study to Evaluate the Treatment Outcome, Safety, Plasma Concentration and Quality of Life of Bedaquiline Treatment in North Indian Patients of MDR TB”. PI: Dr. Shoma Mukherjee, Co- PI: Prof. A. Ray
  • Ongoing ICMR STS Project- Approved on June 2020 titled “A Drug Utilization Study and Safety Analysis of Psychotropic Drugs and its Impact on Quality of Life of Patients attending Psychiatry Outpatient Department of a Tertiary Care Teaching Hospital” Reference ID: 2020-08743 Guide: Dr. Shoma Mukherjee, Student: Arsh Arora
  • Co- supervisor, M.D Pharmacology Thesis titled Evaluation of Antibiotic Utilization with Reference to National Treatment Guidelines and Adverse Event Monitoring in Intensive Care Units of a Tertiary Care Teaching Hospital: A Prospective Study. Supervisor: Prof. Arunabha Ray.
  • Co-supervisor, M. Pharm Research Project, Faculty of Pharmacy, Jamia Hamdard, 2016-2018. To assess knowledge, attitude and perception regarding antimicrobial use and resistance among the physicians, residents and final year medical students in a South Delhi teaching hospital. Supervisor: Prof. N. Saha.
  • Co-supervisor, M. Pharm Research Project, Faculty of Pharmacy, Jamia Hamdard, Nov 2015- 2017.To assess awareness of patients practicing Islam regarding lifestyle modification and medication alteration of antidiabetic during Ramadan: A survey. Supervisor: Prof. N. Saha.
  • Effect of Phlorizin, a SGLT-1 inhibitor, alone and in combination with Metformin on glucose transport in everted sac model of rat intestine. STS- Project Co- Investigator (Reference Id: 2016-02720). Principal Investigator: Prof. N Saha, Department of Pharmacology, HIMSR, Oct 2016.
  • Co- supervisor – Ph.D. Degree in Pharmaceutical Medicine: June 2013 – 2015. Evaluation of oral bioavailability of Xolstat 20mg tablets (containing rosuvastatin calcium equivalent to rosuvastatin 20mg) of Ranbaxy Laboratories Limited in comparison with Crestor 20mg tablets (containing rosuvastatin calcium equivalent rosuvastatin 20mg) of IPR Pharmaceuticals Inc. and to assess the safety profile in healthy adult human subjects under fasting condition.
  • 15 multicentre clinical trials (Phase II – IV) as Medical Monitor & Therapeutic Area Specialist; and ~ 500 healthy volunteers & Phase 1 studies (BA/BE) as Principal Investigator in the capacity of Senior Research Scientist. Facilitated audits by various regulatory bodies (US FDA, WHO, MHRA, THAI FDA, ANVISA etc.)
  • Randomized, open –label study of xxx in subjects with Chemotherapy Induced Anemia.
  • Randomized, comparative, open –label study of intravenous xxx in patients with Non-Dialysis Dependent Chronic Kidney Disease and with Renal – Related Anemia.
  • A phase III, randomized, comparative, open- label study of intravenous xxx in inflammatory bowel disease subjects with iron deficiency anemia.
  • To evaluate the safety, tolerability and efficacy of xxx to patients with colorectal adenocarcinoma previously untreated for metastatic disease.
  • A multicentre, prospective, open label study of the safety and efficacy of xxx in Indian patients with symptomatic osteoarthritis of the knee (s) after initial and repeat treatment.
  • Randomized, prospective, double blind, parallel group, multicentre study to determine safety and efficacy of xxx in treatment of Venous Leg Ulcer.
  • Randomized, prospective, double blind, parallel group, multicentre study to determine safety and efficacy of xxx in treatment of Diabetic Foot Ulcer.
  • Randomized, prospective, double blind, parallel group, multicentre study to determine safety and efficacy of xxx in Laparoscopic scar.
  • A prospective, randomized, placebo- controlled study to evaluate the effect of xxx in the management of advanced cancer cervix
  • Randomized, comparative, open- label study of xxx in subjects with Stage 5 Chronic kidney Disease on Dialysis Therapy (CKD- 5D).
  • Pharmacokinetic and outcome study of xxx in subjects with Haemophilia B
  • Study of xxx in previously treated paediatric subjects with Haemophilia B

Fellowship

  • Member Secretary, Pharmacovigilance Committee, HIMSR & HAHC Hospital, New Delhi – September 2020.
  • Member Coordinator, Pharmacotherapeutics Committee, HAHC Hospital, HIMSR, New Delhi – March 2020.
  • Member, Student Research Advisory Committee, Jamia Hamdard.
  • Deputy Coordinator, Medical Device Monitoring Centre (MDMC), Adverse Drug Monitoring Centre, Hamdard Institute of Medical Sciences & Research under Pharmacovigilance & Materiovigilance Programme of India, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Govt. Of India. Coordinator: Prof. A. Ray. Recognition granted in October 2019.
  • Member, Causality Assessment Committee; Adverse Drug Monitoring Centre, Hamdard Institute of Medical Research (HIMSR), New Delhi - May 2019.
  • Member, Curriculum Subcommittee: Phase –II, Phase III Part II, HIMSR, New Delhi - 2019.
  • Expert Committee Member, India T.B Research Consortium, ICMR, New Delhi.
  • Member, Selection Committee – India T.B Research Consortium, ICMR, New Delhi.
  • Clinical Pharmacology Unit, PGIMER, Chandigarh – Auditor for Up gradation of CPU.
  • Member, Board of Studies for Pharmacology, Hamdard Institute of Medical Sciences (HIMSR), Jamia Hamdard, New Delhi.
  • Certified Member, Advanced Cardiac Life Support (ACLS) & Basic Life Support (BLS) awarded by American Heart Association
  • Advanced Diploma Course in Computer Applications & Quality Management from NIIT, Silchar, Assam.

Membership of Academic Bodies Societies

  • Member of International Association of Therapeutic Drug Monitoring & Clinical Toxicology
  • Member, Delhi Medical Council
  • Life Member Delhi Pharmacological Society
  • Society for Nitric Oxide and Allied Radicals (SNOAR), India
  • Life Member of Indian Pharmacological Society
  • Life Member of Indian Society for Rational Pharmacotherapeutics

Invited Talks and Lectures

  • Plenary Speaker on “Pharmacovigilance Reforms in India: a step forward or two steps backwards” at International Conference on Legal Medicine, Medical Negligence and Litigation in Medical Practice, Pune - Oct 2018.

Workshops/ CMEs/ Conference Organised

  • Organized a Workshop cum awareness Programme on “Pharmacovigilance: A Tool to Ensure Drug Safety” at HIMSR in association with the Indian Pharmacopoeia Commission as Organizing Secretary - November 2019 under the headship of Prof. A Ray (Co-ordinator Adverse Drug Reaction Monitoring Centre, HIMSR.

Workshops/ CMEs/ Conference Attended

  • International webinar on Ensuring the Safety of Medical Devices - Ocular Devices
  • Biomedical Research - ICMR
  • Virtual Biennial SAAP VII & PSI Conference 2021
  • CME – Rational Use of Antimicrobials
  • 18th International Congress of Therapeutic Drug Monitoring& Clinical Toxicology, IATDMCT- Virtual Congress 2020
  • Induction cum Training Program on Materiovigilance (MvPI) organized by Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, GOI
  • MSSO Training on MedDRA Coding organized by Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, GOI
  • Advanced Pharmacovigilance (Research in Pharmacovigilance in the age of COVID -19)– Webinar
  • Co-ordinator Meeting cum Advanced Training Program for Patient Safety Pv Associates working at ADR Monitoring Centres of North Region organized by PGIMER, Chandigarh
  • Revised Basic Course Workshop and AETCOM Workshop under MCI Regional Centre for Medical Education Technologies, Maulana Azad Medical College, Delhi.
  • Workshop on Good Clinical Practices organised by CDSA, Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India
  • Exfoliative Liquid Based Gynecologic Cytology organised by Department of Pathology, HIMSR, Jamia Hamdard, New Delhi
  • Faculty Development Programme on “Energizing Innovative Skills In Pharmaceutical Education And Research”
  • Assessment Of Practical/ Clinical Skills
  • Effective Soft Skills For Clinical Research