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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Hitt J Sharma

Hitt J Sharma

Hitt J Sharma
Serum Institute of India Ltd, India

Biography

Dr. Hitt J. Sharma is working at Serum Institute of India Ltd, Pune (India), a leading Institute and the largest manufacturer of vaccines in India, exporting vaccines through WHO, UNICEF, PAHO to more than 140 countries, worldwide. He is an expert on vaccine clinical trials and is responsible for organizing and monitoring clinical trials. The main emphasis lies upon logistic support to clinical trials, pharmaco-vigilance, preparation of clinical documents and study reports for submission to National regulatory Authority, India and to W.H.O. Dr. Sharma has successfully undertaken numerous vaccine research projects including projects on anti-rabies vaccines, MMR, DPT, BCG, Hepatitis-B, Haemophilus influenzae type b & various pediatric combination vaccines. His research also includes a herbal drug in BPH patients (Pygeum africanum) and a percutaneous BCG vaccine (Onco-BCG) in transitional cell carcinoma of urinary bladder. He has to his credit one of the largest clinical trial with MMR Vaccine wherein he organized and monitored the study on 450,000 children in collaboration with Ministry of Health and Population, Cairo, Egypt. He has many publications on vaccines in National and International journals and is a member of various scientific societies in India.

Research Interest

Clinical trials
Pharmaco-vigilance
Preparation of Clinical documents
Study reports for submission to National regulatory Authority

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