Discussion Forum on ICH-Q9 at ICCBS, University of Karachi on 23 July 2017

1. Q-9 Fundamentals
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
Discussion Forum on
ICH-Q9

2. Risk
Knowledge
How to
apply
Pre-approval
Post-approval
C
H
A
N
G
E

3. Identification
Assessment
Mitigation
Elimination
Communication

4. Practical
Applicable
Predictive
Flexible
Consistent
Process oriented
Integrated Approach

5. ICH Q9 helps to diminish
Unavailability of the product
Release of unacceptable product
Delayed introduction of new product

6. ICH Q9 helps to diminish
Unreasonable recall of drugs
Reluctance in implementation of new technologies
Unreasonable scare & lack of appropriate data to evaluate

7. ICH Q9 benefits
Enhance patient confidence in decision making
More effective use of resources
Transparency and predictability in decisions

8. ICH Q9 benefits
Increased knoeledge of exposure to risk
Continuous improvement & new technology introduction
Enhanced product quality

9. Remember, ICH Q9 is not
intended to apply to risk
management used in a
Pharmacovigilance setting
involving Safety & Efficacy

10. Process
Initiate
Assess
Control
Communic
ate
Review

11. Guiding Principles
• The evaluation of the risk should ultimately link back to the
potential risk to the patient.
• The extent of the risk management process should be
commensurate with the level of risk associated with the
decision.
• A more robust data set will lead to lower uncertainty.
• It is essential to have a clear delineation of the risk question.

12. Guiding Principles
• Risk management should be an iterative process.
• People who apply risk management should have the
appropriate training, skills and experience.
• The risk management process should be appropriately
documented and verifiable.

13. Guide to Initiating Risk Management
• Defining specifically the risk management problem or
question, including the assumptions leading to the question.
• Assembling background information and data on the hazard,
harm or human health impact relevant to the assessment.
• Defining how the assessment information and conclusions will
be used by the decision makers.

14. Guide to Initiating Risk Management
• Identifying the necessary resources, members of the team who
have the appropriate expertise, with the leader clearly
identified.
• Asking the right risk assessment question(s)
• Stating clearly the assumptions in the risk assessment
• Assessing the quality and sufficiency of relevant data
• Specifying a timeline and deliverables for the risk assessment

15. Risk Assessment
What can go wrong
What is likelihood to go wrong
What are the consequences

16. Risk Assessment
Risk Analysis Risk Evaluation
It is a systematic use of
information to identify
specific sources of
harm (hazards) and to
estimate the risk.
It compares the
estimated risk against
given risk criteria using
a quantitative or
qualitative scale to
determine the
significance of the risk.

17. Risk Control
What can be done to mitigate & reduce risks?
What options for controlling risks are available?
What are the impacts of current risk management
decisions on future options for risk management?

18. Risk Control
Risk Reduction Risk Acceptance
It focuses on the
reduction of
probabilities of
occurrence of
harm and
detection of
harm.
It is a decision to
accept risk, i.e.,
no additional risk
control activities
are necessary at
that time.
Risk Mitigation
It focuses on a
reduction of
severity of harm.

19. Risk Communication
The communication among
stakeholders concerning
quality risk management
decisions can be made
through existing channels.
Risk communication is the
exchange or sharing of
information about risk and
risk management between
the decision maker and
other stakeholders.
The information can
relate to the
existence, nature,
form, probability,
severity,
acceptability,
treatment,
detectability or other
aspects of risks to
quality.

20. Risk
Monitoring
& Review
All risk management processes are dynamic/
iterative.
QRM when applied should benefit from new
knowledge with each decision cycle.
QRM is used to enhance future decisions
allowing for continuous improvement.

21. Risk Assessment
Risk Evaluation
Initiate
Risk Management Process
Risk Control
RiskManagementtools&statistictoolbar
(Resources,Interfaces&Linefunctions)
Output / Results of the
Risk Management Process
Risk Communication
No additional risk
Risk Analysis
Risk Mitigation
(incl. elimination and avoidance)
[Severity]
Review
(e.g. Inspections/Audits, Complaints)
Risk Acceptance
Risk Reduction
[Probability ]

22. Thank you
Have a very good time