Abstract

Risk Mitigation Programme in CRO

Prashant Pandya, General Manager, Reliance Life Sciences Pvt Ltd

The rapidly evolving healthcare landscape in India provides a critical window of opportunity for CRO – and a corresponding challenge – for pharmaceutical companies to transform their drug development strategy. Those organizations that successfully forge compliant strategic partnerships and transform their internal operating models will benefit and lay the foundation for fast, sustainable growth. Risk management has been used on an ad-hoc basis for many years in India, however now it’s becoming a more formal and structured part of drug development and life-cycle management due to significant change in marketing authorisation of new dosage form, new route of administration, new manufacturing process of a biotechnologically-derived product (Biosimilar) etc. Accelerating clinical research through a third party (CRO) by using a transactional approach may magnify the risk exposure of pharmaceutical companies. This session provides an overview of various risk mitigation strategy useful for CROs with an analysis of potential liabilities and establishes steps that may help minimize these.