cultural relationship between quality of drugs and prevailing regulatory environment
TRANSCRIPT
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
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
Evolution does not care whether you believe in it or not, no more than gravity does
Quality
SupportRegulations
EXPORT
With few exceptions
PharmaIndustry
Govt. Facilitation
Regulatory Authority
EXPORT
With few exceptions
USA
EU
Japan
Canada
WHO
Australia
Leading the pharmaceutical world through ICH
Common Guidance Formats Language
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
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
Drug Quality
From Moral Obligation toReal Challenges ?
A large number of manufacturing facilitieswith very few exceptions
Honest Question
Honest Question
Does our drug quality competes with minimum
global standards ?
Sincere Concern
Sincere Concern
What is the quality of drugs consumed by our citizens ?
Lets ask from our
Heart
Why notQuality Drugs for us
Who stopped us ?
Lets ask from our
Heart
See back mirror to move forward
See back mirror to move forward
How & who made DRAP incompetent?
If DRAP turns competent
What would happen If DRAP turns competent
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
Learn to live with
difference of opinion
Remove Ego, Manage Knowledge,
Manage Value, Respect Science, Protect Honesty
