Session 6 - Risked Based Quality Management – It Takes a Village!

  • #pioneer
Tuesday, September 15, 2020: 11:15 AM - 12:15 PM
/ CEU Credits:0.2

SESSION CHAIRS & SPEAKERS

Speaker
Kelly Doyle, MS
ePRO Project Manager
PRA Health Sciences
Speaker
Po Nam Loo
Director, Clinical Data Management
MSD R&D (China) Co., Ltd
Session Chair
Stacey King
Director, Data Management
Aperio Clinical Outcomes
Speaker
Suzanne Kincaid CCRA, ACRP-PM, F-ACRP
Chief Operating Officer
Aperio Clinical Outcomes

SESSION DESCRIPTION 

The clinical research industry is ever evolving. With constant changes from updated regulations and new technologies popping like popcorn, it truly takes a village to raise a product from concept to market. This village must house all of the components necessary for a successful Risk Based Quality Management strategy. Risk Based Quality Management (RBQM) is more than risk based monitoring - it is a comprehensive approach to evaluating overall trial risks, with documented measures put in place to manage those risks.

In this session, a panel of industry professionals will discuss ways the various members of this village – project management, corporate operations, data management, and others – can work together to form a holistic RBQM strategy. Learn from the experts what works, what doesn’t, and how you can implement a RBQM strategy for your next medical discovery. 


TOPIC


LEARNING OBJECTIVES

1. RBQM Definition
2. RBQM Accountability Responsibilities
3. RBQM Critical Components
4. RBQM Implementation

Handout(s)


SESSION INFORMATION

CDM Certification Competencies::
Project Management,Clinical Trials Processes, Roles, and Responsibilities,CRF Design

Target Audience:
DM Management,Data Managers,Clinical Operations,Project Managers