Mitigating Against Adverse Events: A Game Changer for Clinical Operations
The timeliness of bringing new health products and drugs to market for patients is critical. Yet meeting stringent regulations such as ICH E6 (R2) and patient protection requirements during the clinical trial research phase are slowing down time to market and increasing the cost of new products, which can be in the millions.
In this webcast, Michael Connolly, Director of Pharma Accounts at Qstream, will share:
- What challenges pharma companies are experiencing in risk-based monitoring effectiveness
- How to pinpoint compliance adherence to ICH E6 (R2)
- Strategies to identify gaps in process and knowledge of monitors, and tailor coaching towards them
About our Speaker:
Enterprise Account Director, Pharma, Qstream
Mike has worked with life sciences companies for over ten years and is a passionate about the power of life sciences to transform and save lives. In his current role as director of pharma accounts in EMEA for Qstream, Mike is focussed on helping life sciences companies empower reps, their front line managers and MSLs with the skills and knowledge required to engage with healthcare professionals as the pharma sales model evolves. He has also held senior positions in the clinical trial and R&D development space with Medidata and Accelrys.