Deepa Arora
Director
Banaras Hindu University
India
Biography
Physician with more than 20 years of experience in clinical development and pharmacovigilance. After working for several years as Vice President and Global Head of drug safety & risk management for Lupin, she founded Clinexel Life Sciences Pvt Limited, that provides consulting and operations services to pharma companies. Deepa has rich experience in conceptualizing innovative products, developing efficient 505b(2) clinic- regulatory strategies for biosimilar and hybrid applications. She was a key member for clinical development and safety monitoring of biosimilars & NCEs in 3 companies. She participated in regulatory meetings with FDA, EMA, rapporteurs and CHMP to discuss the clinical development plans, risk management plans, post marketing data collection required for hybrid applications and requirements of post marketing studies. She has successfully led a consortium of leading generic companies including Teva, Lupin, Sandoz, Alvogen, Mylan, Generis and Gedeon Richter in Europe to conduct post authorization clinical studies imposed as a condition of marketing authorization for a generic product. After successfully completing these studies, results were published in peer reviewed journals.
Research Interest
Pharmacovigilance