Webinar On Risk Management in Clinical Trials

Compliance Trainings, Mississauga
2015-10-05

Description :

ICH Q9 – Quality Risk Management has been present as an FDA Guidance

Document for almost 10 years, and this advocates the utilization of a risk assessment and then risk analysis methodology across all aspects of the pharmaceutical industry; which of course includes R&D and clinical trials. This risk management methodology achieves identification of risks, an analysis step and then  deciding actions to be taken on the most significant. This process ensures that resources are not wasted on doing things that are not delivering benefit in mitigating significant risks.

This webinar will refresh basic Risk Management methodology and then establish how this fits in with the standard stages of a clinical trial. Regulatory inspectors will now expect to see evidence of a risk based approach to a clinical trial, and this course will address the topic of documentation to be created.

Areas Covered in the Session :

Risk management methodology

Utilize the basic principles to take a 'risk-based approach'

Document risks identified

Prioritise risks and plan mitigation actions where necessary

Who Will Benefit:

Data management Teams

Clinical Research Associates

Monitors

Project Managers

Statisticians

Academic Research Organizations' Staff

Representatives of any CROs or other contractors (ePRO etc) who will be supporting clinical trials

Researchers within a healthcare setting

And all clinical research professional embarking on a risk-based approach

Over the past 28 years Jane has moved from routine data cleaning activities, via computer system validation onto training and data quality activities, eventually specializing in Quality Risk Management. Jane has worked for a variety of large pharmaceutical companies and CROs before retiring from GlaxoSmithKline. Jane now operates as a Risk Management Trainer and Consultant, specializing in Study Level Risk Management and Risk Based Monitoring as well as facilitation of risk assessment workshops.

Over the past 28 years Jane has moved from routine data cleaning activities, via computer system validation onto training and data quality activities, eventually specializing in Quality Risk Management. Jane has worked for a variety of large pharmaceutical companies and CROs before retiring from GlaxoSmithKline. Jane now operates as a Risk Management Trainer and Consultant, specializing in Study Level Risk Management and Risk Based Monitoring as well as facilitation of risk assessment workshops.