Dr Deepa Arora is a Physician with more than 20 years of experience in pharma industry and academia. She has led different functions including drug safety for products under clinical development as well as post approval for regulated markets, clinical development of biosimilars of US FDA and EMEA, clinical operations, medical information, post authorization studies and registries.
Dr Arora set-up integrated, regulatory compliant and cost-efficient end to end Pharmacovigilance systems for Lupin and Wockhardt. Under her able leadership, teams successfully cleared PADE and GVP inspections conducted by various regulatory authorities. She’s also the author of the book- “Pharmacovigilance- An Industry Perspective.” Her forte is a clear understanding the regulations and expectations of regulatory authorities required for compliant PV systems and she also ensures compliance with safety aspects scrutinized during GMP and GCP inspections.
Dr Arora successfully led a Consortium of companies for conducting clinical studies in Europe to meet post authorization conditions imposed as an outcome of EMA referral. She was responsible for end to end management of the referral including planning and Project Management of the clinical studies thereby, meeting the conditions of marketing authorization as well publication of these studies in peer reviewed journals. Her passion is to continue strategic planning of the design, outcomes, endpoint(s) of observational studies with good methodological rigour and data quality to facilitate decision making by regulators, market access and HTA decision-making.
Dr Deepa interacted with various regulators in different capacities, as clinical development manager as well as head of pharmacovigilance and participated in pre-submission and end of Phase meetings to discuss the clinical development plan. She also had meetings with rapporteurs and co-rapporteurs to discuss the risk management plan and reach an agreement regarding risk minimization measures and post marketing studies.
She participated in advisory committee meetings with FDA and presented benefit risk evaluation of a generic product under referral to CHMP and a class of drugs to expert committee nominated by PRAC with desired outcomes. She engaged with Indian authorities (PvPI) in drafting pharmacovigilance guidelines for India, designing the curriculum of pharmacovigilance training initiatives of PvPI. She Led preparation of “Guidelines for the management of ADRs with antitubercular drugs” in collaboration with ICMR, CTB division and KOLs. These were released in 2016 for South East Asia
She has worked in Pharma companies like Lupin, Wockhardt and Dabur and also worked in CROs as Clinical Operations Lead and as Project Manager. In her most recent assignment, she’s associated with Lupin as Vice President & Global Head of Drug Safety & Risk Management.