WEBINAR

Risk-Based Monitoring: A Pathway to Efficient Quality Management

Speaker: Jane Tucker , Sue Fitzpatrick

After issuance of the guidance document by FDA on – ‘A Risk Based Approach to Monitoring’ and EMA Reflection Paper on – ‘Risk Based Quality Management in Clinical Trials’, the drug / device development companies, CROs are actively embarking on this paradigm shift in clinical research which has opened an enhanced path to efficient quality management of clinical trial process. The implementation of risk-based study specific monitoring strategies, plans will be a critical component for every study sponsor to ensure high quality and integrity of data, enhance human subject protection, reduce cost and eliminate inefficiencies across clinical trial process. Thorough identification and evaluation of risks to critical study data, processes and thereby designing appropriate monitoring plan with a balance of centralized & onsite monitoring will maximize the effectiveness of risk based monitoring. Considering the importance and need of risk-based monitoring currently in clinical trial management, MakroCare has organized this webinar to provide more insight on this new approach.

Part II : Risk-Based Monitoring: Putting into Practice

(on 5th June 2013; details will be shared later)

Key Topics:

Part I : Risk-Based Monitoring – Putting into Context

• Regulatory requirements
• Broad review of risk based activities
• Study level risk management
• Risk-based monitoring – Adding value to your operations