Lee Truax Bellows 2012 - Quality System Approach and Risk Management for Clinical Trials

Why should you Attend :

Clinical studies continue to fail to meet the minimum regulatory requirements as evidence by regulatory citations that are issued on a fairly consistent basis. What is even more concerning is that these areas of concern remain the same year after year and include inadequacy in; study oversight, protocol compliance, investigational product accountability, training, and IRB/IEC oversight. With all the emphasis on training that many sponsors and investigators put their staff through, the guidance documents issued by the regulatory authorities, continued negative inspections and resulting citations, which in turn result in negative publicity, why does this continue to happen in this day and age? Applying a quality system approach based on risk management will help ensure that industry and their partners, such as third party vendors and site personnel, are better prepared to identify and plan for potential risk areas, plus deal with issues as they arise.

Areas Covered in the Session:

- We will review the key definitions of a quality system approach and risk management

- Provide tips on how to identify risk within a clinical study and discuss how to manage it

- Provide an overview of contingency plans and corrective actions that are utilized once an issue has been identified.

Who will benefit:

Clinical Research managers

Project Managers

Clinical Research Associates

Monitors

Quality Assurance Professionals

Research coordinators

Clinical investigators

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