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2 of 5 Overview by Obaid Ali
1. Saturday, October the 10, 2015
Culture of Quality
Opening Note and Programme overview
Full day workshop
Drugs Regulatory Authority of Pakistan
Habib University, Karachi
Obaid Ali & Roohi B. Obaid
Civil Service Officers/ Deputy Director
2. 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
D
I
S
C
L
A
I
M
E
R
3. About Half a billion
population died
4Lakh per year in Europe
4. Small pox Plague Meningitis
Tuberculos
is
Heart
Attack
Infections Psychiatry Diabetes
10. 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
14. 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
Yes
Don’t
know
29. Clinical
Trial
2000 for
HTN
Further
trials for
stroke &
angina
Employees
Participatio
n
CoI not
reported
Employees
in data
analysis
Manipulati
on in
scientific
reports
Data
fabrication
Reported
Retraction
of several
papers
Publicly
apologized
40. • 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
43. 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
Sorry
the worst nightmare