2 of 5 Overview by Obaid Ali
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Saturday, October the 10, 2015
Culture of QualityOpening Note and Programme overview
Full day workshop
Drugs Regulatory Authority of Pakistan
Habib University, Karachi
Obaid Ali & Roohi B. ObaidCivil Service Officers/ Deputy Director
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Not the view of DRAP
Current judgment of speaker
No obligation on DRAP
Regulatory experience
It has nothing to do with any
specific commercial
product
It is just a knowledge
sharing exercise nothing more than
that
DISCLAI
MER
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About Half a billion population died
4Lakh per year in Europe
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Small pox Plague Meningitis Tuberculosis
Heart Attack Infections Psychiatry Diabetes
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Hepatitis Ebola
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Who Cares?
It is Pharmaceutical Industry … Science … Research ..
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Pharmaceutical Companies
Regulatory Agencies
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Very near to your and your beloved one’s lives
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Drug Safety from Pre Market to Post Market"DO YOU KNOW IN 2008 ....., used to stop
bleeding during open heart surgery killed a lot of patients.
The lives of 22,000 patients in USA alone could have been saved if U.S. regulators had
been quicker to ban it. The same was extensively used in Pakistan too but no body
knows, it killed how many in our country
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2008?
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Over sulfated chondroitin sulfate (OSCS)
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149 deaths
Test was passed
Signals not responded
Finally contamination
detected
Let’s think together
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If it happened in Pakistan, were me & you able to catch?
What do you think can it be caught in testing?
Do you think we are capable to catch such level of contaminant or less?
No
YesDon’t know
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100’s of
Deaths
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2001-2005750m $ Mix up Too much or too
little API Contamination
A number of products, tablet, cream, comtrol release etc.
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Regulations
EnforcementCompliance
Guarantee
?
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1
2 3
4
Let’s identify attribute of culture
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Let’s identify correct relationship
Girl and Mehndi
Boys and Mehndi
Girl and Tattos
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Let’s identify correct relationship
Mehndi & Bangles
Boys and Bangles
Girl and Bangles
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Let’s identify correct relationship
Eid
Exam day
Fun
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A normal brain irrationally puts more weight on a small loss than big one or
sometimes a huge opportunity
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TOOL
Approach
Stan
dard
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Sorry for broken trust … ... I am endlessly sorry
Martin Winterkorn
4,82, 000 cars … > 18 billion USD fine………..
Sep 20, 2015
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Hiding an alleged link b/w Pioglitazone & bladder cancer
Emails raising concern about the issue were deleted
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9 billion USD penalty2014
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Clinical Trial
2000 for HTN
Further trials for stroke & angina
EmployeesParticipatio
n
CoI not reported
Employees in data
analysis
Manipulation in
scientific reports
Data fabrication Reported
Retraction of several
papersPublicly
apologized
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2014-2015Got temporary suspension of
business
Reputational hit Data tempering
False advertisingData hiding Ends up with sorry
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1999 100 M2002 30 M2002 500 M2010 750 M
GMP
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• Off-label use promotion
P
USA • 0.43 billion USD fine
2004
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• Fraud
M
• Kick-backs
USA • 0.95 billion USD fine
2008
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• Off-label use promotion
P
• Kick-backs
USA • 2.3 billion USD fine
2009
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• Off-label use promotion
L
USA • 1.4 billion USD fine
2009
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• Off-label use promotion
AG
USA • 0.60 billion USD fine
2010
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• Off-label use promotion
AZ
• Kick-backs
USA • 0.52 billion USD fine
2010
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• Off-label use promotion
N
• Kick-backs
USA • 0.423 billion USD fine
2010
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• Failure to disclose safety data
• Off-label use promotion
G
• Paying kick-back• Making false
misleading statements
USA • 3 billion USD fine• Criminal & civil
fine
2012
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• Off-label use promotion
AT
USA • 1.9 billion USD fine
2012
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• Off-label use promotion
J
• Kick-backs
USA • 2.2 billion USD fine
2013
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Recognition
• Publicly recognizing the gravity of the crisis
Responsibility
• Leaders taking personal responsibility to manage the crisis
Regret
• Expressing deep regret on behalf of company
Remedy
• Outline the steps going & continue to take to address the situation
Sorrythe worst nightmare
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Mal-practices in drug manufacturing
Regulations came into force
Tragedies occurred
Regulations continue to be stringent & complex
Historical Perspective
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PHARMACEUTICALSA Business driven Profession
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New
To
ols
Approaches
Stan
dard
sE
Q
P
S
REGULATORY
SCIENCE
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Innovation
Science
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Need justifies Outcome
RiskBenefit
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Reasonable Safety is required
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Do you calculate a cost of poor quality at your site?
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Do you calculate a cost ofimproving quality versus failure?
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Science
Rational
QUALITY
METRICS
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Econometrics
Pharmacometrics
Chemometrics
Science
Rational
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Quality Metrics & Case Studies will be discussed
in next talk
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Thank you of your attention