DINNER SHORT COURSE*

TUESDAY, MAY 8 | 5:30 - 8:30 PM

SC2: Implementing RBM and a Clinical QMS with Limited Resources

Many organizations do not have the budget to be able to implement commercial systems to address RBM, or the ability to hire additional staff to conduct specialized RBM analysis. During this dinner workshop we will share with you steps to take to implement RBM and a clinical QMS for your organization using minimal resources.

Key Learning Objectives:

• Overview of the minimum requirements to meet ICH E6 R2
• Organization's needs assessment tool
• Organization's SOP/workflow assessment and gap analysis tool
• Risk assessment tool
• Clinical QMS assessment tool
• Technology assessment tool and considerations
• RBM and Clinical QMS implementation plan
• Case study of one company’s approach to risk management and Clinical QMS
• Change management plan

Instructors:

 Brian Nugent, Senior Director, Clinical Compliance, GRAIL, Inc.

Brian has spent over 30 years in health care and 15 years in the drug development industry spanning both biopharmaceutical and CRO organizations with director-level responsibility for quality, clinical operations, process development, TMF and safety. Over the past several years, Brian has concentrated his efforts on clinical operations process development and the establishment of quality systems to include QRM/QbD, as well as the standardization of risk management plans.

 Angie Maurer, RN, BSN, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

Angie has spent over 19 years in healthcare and 15 years in the drug development and medical device industries spanning biopharmaceutical, medical device and CRO organizations. Her experiences include drug safety, study monitoring, study and program management, process development, therapeutic area and clinical operations training, and risk management. Over the past several years Angie has concentrated her efforts on clinical operations process development and implementation of risk management tools and trainings to support risk management programs.

*Separate registration required.