PANEL SESSION Risk Management Emerging Practices and …...Risk Management Emerging Practices and the Impact of ICH E6 (R2) Updates ... Chief Scientific Officer, Cyntegrity Oleg Shevaldyshev,

PANEL SESSION

Risk Management Emerging

Practices and the Impact of

ICH E6 (R2) Updates

©2018 Metrics Champion Consortium All rights reserved

The Panelists

Duncan Hall, CEO and Founder, Triumph Research Intelligence

Johann Proeve, Chief Scientific Officer, Cyntegrity

Oleg Shevaldyshev, Associate Director, Quality Assurance, PRA Health Sciences

Renee Ekeland, Senior Quality Compliance Manager, CSL Behring


• How should we identify high priority risks?

• What are the challenges with risk scores?

• Which studies are suitable for a risk-based approach?

• How does outsourcing impact the risk-based approach?


2009 2011 2014 2015 2016

A Developing Landscape…

Redefining Quality: Errors that matter & Issues that matter –

Human Subject Protection & Reliability of Trial Results

4


5.0.1 Critical Process &

Data Identification

5.0.2 Risk Identification

5.0.3 Risk Evaluation

5.0.4 Risk Control

5.18.3 Extent & Nature of

Monitoring

ICH E6 (R2)

5.0.5 Risk Communication

5.0.6 Risk Review

5.0.7 Risk Reporting



Data Identification



5.0.4 Risk Control

5.0.5 Risk Communication

5.0.6 Risk Review


ICH E6 (R2) – It’s Not Linear!


Monitoring


More than Numbers and Checkboxes:

Critical Data – Critical Process – Critical Thinking


Data Identification



5.0.4 Risk Control

5.0.5 Risk Communication 5.0.6 Risk Review



Monitoring

ICH E6 (R2)


More than Numbers and Checkboxes:

Critical Data – Critical Process – Critical Thinking


Data Identification



5.0.4 Risk Control

5.0.5 Risk Communication 5.0.6 Risk Review



Monitoring

ICH E6 (R2)


Redesigned to

improve

alignment with

ICHE6(R2)

5.0 (5.0.1-5.0.7)

Quality

Management

Risk Assessment & Mitigation Management

Tool v2.0 released 9/2018

MCC Risk

Management Training

Course available

12/2018


What is the best way to identify high priority

risks?


AUDIENCE POLLING QUESTION #1

What do you find is the best starting point for identifying high

priority risks? (select one)

A. Risks/issues from previous trials

B. Critical data & critical processes

C. Pre-existing list of potential risks (e.g. RACT)

D. Team experience


What is the best way to identify high priority

risks?


What are the challenges in determining risk

scores?



Which of the following is the most significant challenge with risk

scores? (select one)

A. Uncertainty in scoring of Likelihood, Impact and/or Detection

B. Consistent scoring within a trial

C. Consistent scoring across trials

D. Determining which risks to act on after scoring

E. Lack of critical thinking


What are the challenges in determining risk

scores?


Which studies are suitable for RBM or RBQM?



Which studies / phases do you think are candidates for the

implementation of RBM / RBQM? (select one)

A. Phase 3 only

B. Phase 2 & 3

C. Phase 3 & 4

D. All phases 2-4

E. All phases 1-4


Which studies are suitable for RBM or RBQM?


How should RBM / RBQM trials be handled

when outsourced?



In an outsourced setting, who should identify and assess the

risks? (select one)

A. Sponsor company

B. CRO

C. Sponsor and CRO jointly

D. Sponsor first and then CRO adds operational risks

E. CRO first and then sponsor adds oversight risks


How should RBM / RBQM trials be handled

when outsourced?


Wrap-Up

• How should we identify high priority risks?

– Critical data, critical process, critical thinking

– Knowing when to stop

• What are the challenges with risk scores?

– Managing the uncertainty

– More people involved leads to more challenges with scoring

• Which studies are suitable for a risk-based approach?

– All according to ICH E6 (R2)

– Thinking beyond RBM and reduced SDV

• How does outsourcing impact the risk-based approach?

– Should have at least some joint element


Thank you!

Duncan Hall, CEO and Founder, Triumph Research Intelligence

Johann Proeve, Chief Scientific Officer, Cyntegrity

Oleg Shevaldyshev, Associate Director, Quality Assurance, PRA Health Sciences

Renee Ekeland, Senior Quality Compliance Manager, CSL Behring

Documents

PANEL SESSION Risk Management Emerging Practices and …...Risk Management Emerging Practices and the Impact of ICH E6 (R2) Updates ... Chief Scientific Officer, Cyntegrity Oleg Shevaldyshev,