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Hosted Session/Non-CE: Case Study hosted by COD Research USA INC: Decode the Risk Management for the Combination Products: The Operational Challenges and Actionable Safety Strategies
Session Chair(s)
Jay Dave, DDS, MSc
Technical Director-Patient Safety, Risk Management & RA
COD Research Pvt LTD, India
Advancements in personalised medicines are with newer delivery systems. This poses unique challenge for risk management, since medicines have devices combined as whole product. Lack of regulatory guidance, use of digital components, device’s inherent risk, efficacy and safety of drug’s dependency on device and user errors are some of the challenges making it complex. Integrated principals on safety strategies along with agile multidisciplinary team are utilized to decode on such challenges. The session would flow with historical and current examples/own case study to unravel the balancing act between drug & device.
Learning Objective :
Featured Learning Points:
- The challenges in developing Risk Management strategies for Combination product
- What are the principles and model utilized while creating such strategies, how it operationally performed
- Historical and current case studies and solutions with the Best Practices and Future Outlook
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