DEEPA ARORA, Director, CLINEXEL Life Sciences

•   25-year experience in Pharma industry, academia and patient care.
•   Experience in Pharmacovigilance, Clinical Development, Clinical Operations, Medical Information, preclinical studies and patient care.
•   Set-up and successfully led efficient and regulatory compliant Global Pharmacovigilance function for two midsize companies.
•   As the most responsible person of Pharmacovigilance, successfully faced PV inspections from different regulatory authorities without any critical or major findings
•   Participated in various regulatory meetings, including pre-submission meetings with rapporteurs and co-rapporteurs to discuss the risk management plan, requirements of post marketing studies and other commitments as marketing authorization holder
•   Interacted with various regulatory authority (MHRA, FDA, EMA, INFARMED, Health Canada, TGA) regarding clinical development path, drug safety assessment and risk management of biosimilars and other products
•   Key member for clinical development and safety management of biosimilars. Worked in the clinical development of biosimilar insulins, GCSF and Etanercept.
•   While working in Lupin, I successfully led Trimetazidine consortium of leading generic companies including Teva, Sandoz, Alvogen, Mylan, Generis and Gedeon Richter in Europe to conduct post authorization clinical studies imposed as a condition of marketing authorization for Trimetazidine. I did Project Management of these studies and after successfully completing these studies, published the results of these studies in peer reviewed journals.
•   Experience of successfully driving public-private partnership with multiple stakeholders. Led the preparation of “Guidelines for the management of ADRs with anti-tubercular drugs” in collaboration with ICMR, CTB division and KOLs. These were released in 2016 for South East Asia
•   Engaged with Indian authorities (PvPI) in drafting pharmacovigilance guidelines for India, designing the curriculum of pharmacovigilance training initiatives of PvPI
•   Faculty and speaker at various international forums for PV and Clinical Research
•   Author of the book written on industry practices in Pharmacovigilance “Pharmacovigilance- An Industry Perspective”
•   Subject Matter Expert- Well versed with latest regulations and inspection trends in Pharmacovigilance globally