Quality Risk Management
in Clinical Development– Managing Risks & Sustaining Quality
Inaugural Singapore Research Ethics Conference
March 2, 2018, Singapore
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Objectives
‘Risk’ & ’Risk Management’ - definitions
Risk Management in ’CD’ space – process/approach
Identification
Assessment
Mitigation plan
Actioning
Action evaluation
CQM framework
Q&As
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Disclaimer
Presentations are intended for informational purposes only and
do not replace independent professional judgment. Statements
of fact and opinions expressed are those of the participants
individually and, unless expressly stated to the contrary, are not
the opinion or position of the Janssen Research and
Development, a division of Johnson & Johnson Pte. Ltd. or its
affiliates.
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Risk & Risk Management
Risk:- … is the potential of gaining or losing something
of value. Values (such as physical health, social status,
emotional well-being, or financial wealth) can be
gained or lost when taking risk resulting from a given
action or inaction, foreseen or unforeseen (planned or
not planned). (Wikipedia)
Risk: - … is the possibility of something bad happening,
or something bad that might happen. (Cambridge
Dictionary
Risk:- … is the combination of the probability of
occurrence of harm and the severity of that harm.
(ICH Q9
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Risk & Risk Management
Risk Management:- … is the identification, assessment,
and prioritization of risks (defined in ISO 31000 as the
effect of uncertainty on objectives) followed by
coordinated and economical application of resources
to minimize, monitor, and control the probability
and/or impact of unfortunate events or to maximize
the realization of opportunities. (ISO 31000)
Risk Management:- … consists of identification of
hazards and the analysis and evaluation of the risks
associated with exposure to those hazards. (ICH Q9)
Quality Risk Management:- … is a systematic process
for the assessment, control, communication and
review of risks to the quality of the drug (medicinal)
product across the product lifecycle. (ICH Q9)
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Clinical Development6
Source: www.asbestos.com/
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Risks
We are constantly facing:
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Regulatory
risks
Compliance
risks
Reputational
risks
Financial
risks
Many other…
risks
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Risk Management
RiskAssessment
Riskmitigation
Actioning(CAPA)
ActionEvaluation
Risk Identification
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RISKS
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Clinical Development9
Source: www.asbestos.com/
RiskAssessment
Riskmitigation
Actioning(CAPA)
ActionEvaluation
Risk Identification
RISKS
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Risk Identification
Identification
Where we are vs. where we need to be, i.e., any ‘GAP’ against e.g., laws, regulations, SOPs, applicable standards etc.
How to identify?
Proactive: self-inspections, self-checking, self-reviews, intelligence activities, etc.
Mapping out
Process/key stages
Risk mapping
Reactive: audit, inspection, other quality activities
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Risk Assessment
How ‘big’/significant is the ‘gap’? (severity)
What’s the impact of the ‘gap’? (severity)
How likely it would/could happen? (probability)
Many tools to assist us to answer these questions ….
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Risk Assessment
What’s underline/root cause(s)?
Can we do anything about the root cause(s)?
Who (stakeholders) should be involved in answering the above questions?
Questions to ask ourselves:
If I do NOT do anything, what would happen adversely?
If I do something, what would be the benefits (cost/impact)?
Engaging/involving all key stakeholders to ensure the risks/gap thoroughly reviewed and investigated
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Risk Mitigation
Actions plan
Targeting the risk/issues identified
(Corrections/Corrective actions)
Targeting the prevention (Preventative actions)
Proactive actions, e.g.,
In anticipation of new/updated regulations/requirements
Continuing improvement, raising the standard bar
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Risk Mitigation
Clearly define (the SMART rule):
What are the action activities/deliverables?
Who is the ‘owner’/lead of the actions?
Who should be included in the action
‘workstream’?
What is the timeline?
What is/are the key ‘indicator(s)’ for the
effectiveness of the actions?
Consider a Sr. Mgt. ‘sponsor’ for the actions
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Action Implementation
Follow the action plan
Regularly review the status & progress/milestones
Adjust accordingly if necessary
Update with the ‘sponsor’, as well as stakeholders, for
the continuing engagement and support
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Action Evaluation
Effectiveness check against the pre-defined
‘effectiveness indicators’
If not effective, or not fully effective, then it may need to restart the ‘cycle’
Any risks/adverse effects created?
Consider Lessons Learned
The entire process should be properly documented as
part of the robust Quality Management System
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Clinical QMS18
Foundational Aspects
Processes
Resources, Roles & Responsibilities
Risk Management
Issue Management
Knowledge Management
Partnering
Elements of a Clinical QMS Conceptual Framework
Documentation Supporting Achievement of Quality
Ass
ess
ing
the
CQ
MS
Man
age
me
nt
Re
vie
w
Understand the ContextLeadership
Commitment to Quality
Organizational
Commitment to Quality
Continual Improvement
of the Framework
Source: TransCelerate Inc.
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Pyramid of Quality19
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Key Take-Aways…
Constantly facing ‘risks’ in the entire cycle of Clinical
Development
Managing risks involves
Risk identification (proactive/reactive)
Risk assessment
Risk mitigation/control (action planning)
Actioning (CAPA)
Action evaluation
RM: an integral part of CQM to ensure and maintain
high quality & compliance
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Many Thanks…
Questions?
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