cultural relationship between quality of drugs and prevailing regulatory environment
TRANSCRIPT
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Cultural Relationship between Quality of Drugs & Prevailing Regulatory Environment
Obaid Ali, R. Ph., M. Phil., Ph. D.Deputy Director at Drug Regulatory Authority of Pakistan
05 min presentation of 10 linesPPMA Summit 2016
03rd MayKarachi
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Disclaimer
A current judgment & personal view as a regulator based on experience and knowledge received from US-FDA, Health Canada, WHO etc. It may not be considered as view and
obligation on DRAP
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Evolution does not care whether you believe in it or not, no more than gravity does
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Quality
SupportRegulations
EXPORT
With few exceptions
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PharmaIndustry
Govt. Facilitation
Regulatory Authority
EXPORT
With few exceptions
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USA
EU
Japan
Canada
WHO
Australia
Leading the pharmaceutical world through ICH
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Common Guidance Formats Language
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Common Guidance Formats Language
Lets thank and respect the one and only Pakistani whose 45+ year worthy contribution
is unmatched so far on the global radar
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Common Guidance Formats Language
Lets thank and respect the one and only Pakistani whose 45+ year worthy contribution
is unmatched so far on the global radar
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Drug Quality
From Moral Obligation toReal Challenges ?
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A large number of manufacturing facilitieswith very few exceptions
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Honest Question
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Honest Question
Does our drug quality competes with minimum
global standards ?
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Sincere Concern
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Sincere Concern
What is the quality of drugs consumed by our citizens ?
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Lets ask from our
Heart
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Why notQuality Drugs for us
Who stopped us ?
Lets ask from our
Heart
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See back mirror to move forward
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See back mirror to move forward
How & who made DRAP incompetent?
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If DRAP turns competent
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What would happen If DRAP turns competent
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Time to take decision for your loved one
Life cannot be weighed with costWe must not allow to play with life, if does
not have minimum standards of quality
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Learn to live with
difference of opinion
Remove Ego, Manage Knowledge,
Manage Value, Respect Science, Protect Honesty