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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