Reasons for quality becoming a cardinal priority for most organizations: Competition – Today’s market demand high quality products at low cost. Having `high quality’ reputation is not enough! Internal cost of maintaining the reputation should be less. Changing customer – The new customer is not only commanding priority based on volume but is more demanding about the “quality system.” Obstacles of Quality -(change ,poor habits , adherence , misconceptions) Cost of Quality

1. By Dr/ Mohamed Aboushanab

2. CONFIDENTIAL
2
▪ Importance of Pharmacovigilance
▪ Definitions
▪ Safety Reporting Process
▪ PV Contact Information
Contents for Pharmacovigilance Basic Training

3. CONFIDENTIAL
3
WHAT IS THE PHARMACOVIGILANCE RESPONSIBILITY OF
MARKETING AUTHORISATION HOLDER (MAH)?
Before a medicinal product can be placed on the
market, it has to go through an intensive and long
process of achieving a marketing authorization (MA).
During this process, national and international
competent authorities (CAs) assess the documentation
that has been submitted by the pharmaceutical
company to confirm the efficacy, safety and quality of
the medicinal product.
Part of the documentation consists of clinical trial
results, in which not only the efficacy but also the safety
of the drug is documented.
After approval of MA and the medicine is on the market
there is also a need for continued surveillance of the
safety of the product – this is also known as post-MA
surveillance. These are all part of the
Pharmacovigilance process

4. CONFIDENTIAL
4
Why Pharmacovigilance (PV) Reporting is
Important?
 Regulatory requirements
 For the Patients
 For the Company/Products
 To protect the patients
 To provide the information to healthcare
professionals for proper use
 To meet the regulatory requirements
 To avoid legal issues
 To protect the business

5. What is Pharmacovigilance?
Definition
Pharmaco Vigilance
Medicine
The science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other drug related
problems (WHO, 2002)
To Watch
5

6. PHARMACOVIGILANCE OBJECTIVE
In line with this general definition, underlying objectives of the applicable legislation for
pharmacovigilance are:
• preventing harm from adverse reactions in humans arising from the use of
authorized medicinal products within or outside the terms of marketing authorization or
from occupational exposure; and
• promoting the safe and effective use of medicinal products, in particular through
providing timely information about the safety of medicinal products to patients, healthcare prof
essionals and the public.
Pharmacovigilance is therefore an activity contributing to the protection of patients‘
and public health.
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7. What is Safety Information (1/2)?
Definition
▪ Adverse event
▪ Lack of efficacy
▪ Overdose/incorrect dosage (accidental or intentional)
▪ Abuse/misuse (e.g., patients sharing medication) - even
without resulting adverse reaction
▪ Accidental exposure (e.g., child takes parent’s medication)
▪ Medication error
▪ Withdrawal reactions
▪ Disease progression/exacerbation of existing disease
▪ Drug-drug/Drug-food interactions
Any information from any source containing information including:
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8.  Exposure to drug during pregnancy, where the embryo or fetus may
have been exposed to medicinal products (either through maternal
exposure or transmission of a medicinal product via semen following
paternal exposure)
 Exposure to drug during lactation (including uneventful)
 Suspected counterfeit product
 Product Quality Complaint (PQC) with safety related/medically
important information
 Occupational exposure
 Off-label use
What is Safety Information (2/2)?
Definition
8

9. CONFIDENTIAL
A Patient
: gender, age , initials, race
etc.
An Adverse Event
: any adverse event/ adverse
experience, safety
information, or quality
complaint
A Product
: suspected drug/ device
A Reporter
: HCP, caregiver, patient
etc.
Four Basic Elements in a Valid Safety Report
4 minimum criteria for Regulatory Reporting
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10. Recognize safety information
Collect the most complete information possible
Report the information within timelines via
appropriate communication channel
What is Your Role?
Responsibility of all Health care Professionals
WHEN IN DOUBT: REPORT IT!
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11. What Happen When You Forward A Report?
Pharmacovigilance workflow
Any source
Local Safety Manager
Any POS personnel
(or service provider, if applicable)
Global Case Receipt Mailbox
Timeframe to Global Case
Receipt Mailbox:
Immediately within 24 hours
of receipt or the next working
day in the case of receipt the
day prior to or during a weekend,
but no later than 3 calendar
days
Immediately or
within 24 hours
Egyptian PV Center (EPVC)
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Timeframe to EPVC:
Serious AEs:
- Within 15 calendar days of DFR
Non serious AE and other non AE
Safety Information:
- Within 90 calendar days of DFR

12. QUALITY MANAGEMENT SYSTEM

13. 13
CONTENTS
1-Introduction
2-QC vs QA vs TQM
3-Documentation
4-Quality management methods & techniques
a)Process mapping
b)PDCA cycle
c)Lean Six Sigma
d)Risk Analysis
e)Root cause analysis

14. 14
1-INTRODUCTION
QUALITY & QUANTITY
WHEN DID IT START?

15. DEFINITIONS
 Conformance to specifications
 Perfection
 Doing it right the 1st time
 Freedom from defects
 A degree of excellence
 Fitness for intended purpose / Use

16. DEFINITIONS
 Customer Satisfaction
 Quality is the totality of characteristics of an entity that bears on its ability
to satisfy the stated or implied needs.
 Who is customer?
 How can I measure satisfaction?
 (surveys , returns , complaints , lost business )
 Customer expectations (POS Mob App)

17. 17
WHY QUALITY?
Reasons for quality becoming a cardinal priority for most organizations:
 Competition – Today’s market demand high quality products at low cost.
Having `high quality’ reputation is not enough! Internal cost of maintaining
the reputation should be less.
 Changing customer – The new customer is not only commanding
priority based on volume but is more demanding about the “quality system.”
 Obstacles of Quality -(change ,poor habits , adherence , misconceptions)
 Cost of Quality

18. DIFFERENCE BETWEEN QUALITY
ASSURANCE AND QUALITY CONTROL
Quality control Quality assurance
Product oriented Process oriented
Reactive approach Proactive approach
Focuses on testing for quality Focuses on building in quality
Meant for implementing the process developed by a
team
Meant for developing and organizing the best quality
Process
Makes sure that the results of what you have done
are what you expected
Makes sure that you are doing the right thing the
right way
Corrective action Preventive action
Detects defects Prevents defects

19. TOTAL QUALITY MANAGEMENT (TQM)
 TQM may be defined as an integrated organizational approach (leadership)
Definition :-
In delighting customers by meeting their expectations on a continuous basis through
everyone involved with the organization working on continuous improvement in all
spheres namely-process, products and service along with proper problem solving
methodology .
 TQM is a journey – it is the path as well as the goal .

20. BENEFITS OF TQM
For customers
• Greater care
• Value for money
• Greater satisfaction
• Better availability
• Result in better customer
loyalty
For company
(organization )
• Continuous improvement in
quality
• Better motivated work force
• Defects are reduced
• Reduction in cost
• Increase in productivity
• Faster solution of problems
For employees
• Empowerment
• More respect
• More training and better
skill
• Appreciation and
recognition
• Work satisfaction

21. DOCUMENTATION(DMS)
 The most fundamental part in QMS is how to document your processes and
activities and how to archive these docs
 SOPs
 Records
 Checklists
 Document control

24. What is mapping ?
 Process mapping is a tools for understanding the process and tackle the
process problems
 why is mapping ?
 is a workflow diagram to bring a clearer understanding of a process
variation , minimize wastes , improve process capability , reduce defects
and costs .(by diff techniques value stream mapping , SWOT)
QUALITY MANAGEMENT
METHODS& TECHNIQUES

25. The importance of mapping :
1. Identify the points in the process that need to be controlled
2. Ensure the time and efficiency of every operation
3. Discover troubles areas
4. standardize the work process
5. Improve quality . Productivity and performance
6. Discover the sources process variations
7. Improve quality , minimize defects and costs

26. FLOW CHARTS

27. • Check : monitor and
measure processes against
policy. all results and deviations
must be reported and tracked
• Act : take actions to
continually improve
performance
• Do : implement the process
• PLAN :establish the objectives
and processes necessary to deliver
results in accordance with the
organization's policy (plan smart)
Plan Do
Check
Act
DEMING OR PDCA CYCLE

28. LEAN SIX SIGMA
Lean tools and techniques are used to standardize work and
remove waste and non value – added activities
Six sigma tools and techniques are used to attack the variation
present in processes

29. 6 SIGMA
It measures how many defects/errors in a process.
Then figure out how to eliminate them
Finally get as close to perfection as possible
Six sigma methodology provides the techniques and tools to
improve the process capability and reduce the variability (defects
) in any process .
Six sigma was first introduced by in the 1970s.
Importance of analytics

30. LEAN
 Eliminating waste
 Creates processes that need less human effort ,less space , and less time
 Provide services at far less costs and with much fewer defects ,compared
with traditional business systems

31. EIGHT TYPES OF WASTES
 Wasted human resources – too much people
 Defects- parts that ’ s not right & needs fixing
 Inventory - parts waiting to be worked
 Overproduction – too much parts
 Waiting time – waiting for parts to arrive
 Motion – unnecessary human movement
 Transportation – moving people & parts
 Processing waste – processes we have to do that doesn’t add value to the product
or service we are supposed to be producing

32. LEAN BENEFITS
 Reduced cycle times
 Lower handling costs
 Faster lead times
 Decreased floor space usage
 Lower inventory with greater inventory turns
 Improved customer responsiveness and service
 Improved quality
 Higher profit margins

33. RISK ANALYSIS
RISK ANALYSIS
 Performing a risk analysis on your
business processes can help you
detect potential nonconformities
 Describe the risk
 Describe the potential effects
 Quantify likelihood of occurrence
(consider frequency )
 Quantify severity of consequence
( consider harm or damage )
 Assig risk rating (likelihood x
severity)
 Risk rating > 4 shall be controlled
SCORE RATINGS
 1 = very low
 2 = low
 3= moderate
 4= high
 5 = very high

34. RMS
 Pick a process that contain risk
 (materials , equipments , personnel , premises
 Draw the diagram
 Brainstorm risks and failure modes
 Determine probability & severity
 Calculate risk
 Analyze , prioritize , redesign

35. OVERVIEW OF A TYPICAL
QUALITY RISK MANAGEMENT PROCESS

36. ROOT CAUSE ANALYSIS APPROACH
5 Whys
It was originated in japan .Japanese people believe that by
asking 5 whys you can figure out the root cause of the
problem and find the solution however it doesn’t have to be
5 it can be 7 or 8