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Emerging Positions and Developing Vacuum
for Pharmaceutical Sciences
Obaid Ali, R. Ph., M.Phil., Ph. D.
Civil Service Officer/ DRAP, Government of Pakistan
Member ISPE & PDA
03 Nov 2017
Faculty of Pharmacy,
University of Sindh
Disclaimer: Not the obligation of organization or association to which I
belong, will be discussing science behind, current scenarios, strategies,
approaches and tools to minimize the potential of harm
My all thanks goes to Prof. Abdullah Dayo, Worthy Vice Chancellor, Faculty
teachers and loving students for inviting me in scientific conference
Priority
About 0.5 billion died
0.4 million/year-Europe
If you can imagine, you can achieve
Alexander Fleming
Sept 28th 1928
It is Pharmaceutical Industry … Science … Research ..
Who takes care of the ailing humanity
Regulations Protect
&
Promote Public Health
Who Cares?
It is you … it is you …. it is you …..
Pharmaceutical
Companies Regulatory
Agencies
Safety Efficacy Quality
D R U G
Pre-Registration Post-RegistrationManufacturing
Regulations Protect
&
Promote Public Health
Pre-Registration Post-RegistrationManufacturing
Pre-Registration Post-RegistrationManufacturing
Concept and Animal Studies
Pre-Registration Post-RegistrationManufacturing
Concept and Animal Studies
Clinical Studies
Pre-Registration Post-RegistrationManufacturing
125% 75%
98%
102%
Pre-Registration Post-RegistrationManufacturing
Pre-Registration Post-RegistrationManufacturing
Consistency
Pre-Registration Post-RegistrationManufacturing
Consistency Mix-up
Pre-Registration Post-RegistrationManufacturing
Consistency Contamination Cross ContaminationMix-up
Pre-Registration Post-RegistrationManufacturing
Consistency Contamination Cross ContaminationMix-up
Within Batch
Batch after Batch
Pre-Registration Post-RegistrationManufacturing
Consistency Contamination Cross ContaminationMix-up
Within Batch
Batch after Batch
With same product of other batch, or other
product or dust, or microbe
150 lives
Pakistan
149 deaths
USA
Meningitis
Outbreak
It is 21st Century
100’s
of
Deaths
Pre-Registration Post-RegistrationManufacturing
Pharmacovigilance
Pre-Registration Post-RegistrationManufacturing
Pharmacovigilance
Quality Surveillance
Pre-Registration Post-RegistrationManufacturing
Pharmacovigilance
Quality Surveillance
Medication Safety
The lives of 22,000
patients in USA alone
could have been saved
if U.S. regulators had
been quicker to ban it.
Pre-Registration Post-RegistrationManufacturing
Pre-Registration Post-RegistrationManufacturing
New Drug Generic Drug
Expended Access Navigator Tool
Nov 02nd 2017
Pre-Registration Post-RegistrationManufacturing
Pharmacists
Pre-Registration Post-RegistrationManufacturing
Pharmacists
Health Care Sciences, Pharmaceutical Science,
Pharmaceutical Engineering
Role of Healthcare Industry in Economy
2 Billion 1200 Billion
What was our legacy and What we did
Where we are???
200 M with great history
Where we will hit???
It’s a recent 30 year story
Higher education
Immigration
No more comment
Have a dream
50 overs
300 balls
18000
Cultural
Emotional
Intellectual
Perceptual
Block
Plan, Protect and Run Fast
Understand
current
capacity
Think
efficiently
Strengthen
human
resource with
modern tools
Must Not
Can be Done
Knowledge
bank
WHAT …
Strength lies in Differences not in Similarities
Lets meet
Strength lies in differences
not similarities
John Pemberton
(1831-1888)
Coca Cola
Hubert Humphrey
(1911-1978)
No dispensing without
Pharmacist (Oct 26th 1951)
Dora Nkem Akunyili
(1954-2014)
Counterfeit ..
Musadik Malik
Let’s Learn
How to learn … How to contribute …. How to enhance its impact …..
Learn, De-learn & Re-learn
Thanks
Khalid Yusuf Saheb
Request for his best
health
Thanks

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Emerging Positions and Developing Vacuum in Pharmaceutical Sciences