Agenda

Time Zone Preference

Tuesday, Sept. 28, 2021

9:00 AM - 2:00 PM

Speaker Ready Room

10:00 AM - 10:30 AM

Summit Opening

10:30 AM - 11:45 AM

Keynote: ICH E6(R3) Guideline for Good Clinical Practice Update

M. Khair ElZarrad, PhD, MPH
ICH E6(R3) Rapporteur, FDA
Deputy Director, Office of Medical Policy
CDER, FDA

11:45 AM - 12:30 PM

Break

12:30 PM - 2:30 PM

Risk-Based Quality Management Critical Thinking Workshop — What Can Go Wrong?

2:30 PM

Day 1 Closes

Wednesday, Sept. 29, 2021

9:30 AM - 9:45 AM

Welcome

9:45 AM - 11:15 AM

Breakout Session #1

Quality-by-Design and Risk-Based Quality Management Track

Managing Risk Across a Portfolio of Studies

Identifying Common Risk Factors to Support Tiering Sites for Monitoring

RBQM Documentation Approaches: Lessons Learned and Points to Consider

RBQM with CROs — Best Practice Discussion

Vendor Oversight Track

Selection, Implementation and Use of KPIs in a Sponsor-CRO Collaboration

From Reactive Spreadsheets to Predictive Applications: Modern Approaches to Effective Oversight

11:20 AM - 11:45 AM

Breakout Session #1 Readouts

11:45 AM - 12:30 PM

Break

12:30 PM - 2:00 PM

Breakout Session #2

Quality-by-Design and Risk-Based Quality Management Track

Linking Issues/CAPAs and Risks — Still a Challenge?

The Value of and the Approach to a Retrospective Risk-Based Quality Management Analysis

Vendor Oversight Track

Using Metrics to ID Issues and Drive Improvement Activities

IT System Selection - Don't Make These Mistakes

2:05 PM - 2:30 PM

Breakout Session #2 Readouts

2:30 PM

Day 2 Closes

Thursday, Sept. 30, 2021

9:30 AM - 9:45 AM

Welcome

9:45 AM - 11:15 AM

Breakout Session #3

Quality-by-Design and Risk-Based Quality Management Track

How to Define Critical Processes and Critical Data

Oversight of RBQM with a CRO

How to Measure Success in a Decentralized Trial

RBQM Maturity Model — How to Manage Critical Implementation Components When They are Maturing at a Different Pace? Small to Large Sponsor/CRO, Implementation Adaptability

The Central Monitor Says a Risk Threshold has been Breached … Now What?

Vendor Oversight Track

Decentralized Trials: How Do You Oversee, Manage New Vendors

Oversight of RBQM with a CRO

How to Use Metrics to Gain Insights About Site Activation and Patient Enrollment

11:20 AM - 11:45 AM

Breakout Session #3 Readouts

11:45 AM - 12:30 PM

Break

12:30 PM - 12:45 PM

Champion Awards Public

Champion Awards

12:45 PM - 1:45 PM

Quality Tolerance Limits (QTLs): Why Are They So Challenging? And How Can MCC Help?

1:45 PM - 2:00 PM

Summit Close