Harmonization and Opportunites (Nov 2015)
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Transcript of Harmonization and Opportunites (Nov 2015)
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Obaid Ali & Roohi B. ObaidCivil Services Officer at Drugs Regulatory Authority of Pakistan
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Harmonization Creates Opportunities for Both Regulatory Professionals and Agencies in
Developing Countries
Roohi B. Obaid & Obaid AliCivil Service Officer
at Drug Regulatory Authority of Pakistan
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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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Can anyone assess the Safety
Efficacy & Quality of the drug by naked
eye ?
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Opening Message
Visible, Sub-visible & invisible Challenges
Harmonization, Globalization & Standardization
Projects & Map of Opportunities
Closing Message
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If you want to go fast, go aloneIf you want to go far, go together
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About Half a billion population died
4 Lac per year in Europe
Recall the Retard Enemies and Sad Memories
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Recall the Retard Enemies and Sad Memories
Small pox Plague Meningitis Tuberculosis
Heart Attack Infections Psychiatry Diabetes
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Current Issues & Challenges
Hepatitis Ebola
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Humans
Their systems
Their pain
SI
MILAR
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Humans
Their systems
Their pain
SI
MILAR
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Humans
Their systems
Their pain
SI
MILAR
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Do disease has a boundary?
Quality Treatment ???
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Every human deserves Quality Healthcare
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Lets have a look at the back yard
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Lets have a look at the back yard
Toxic solvent DEG
USA 1937
100s of deaths
An antibiotic
elixir
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Lets have a look at the back yard
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2008?
Lets have a look at the back yard
Over sulfated chondroitin sulfate (OSCS)
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Lets have a look at the back yard
> 100 deaths
PIC Tragedy
Material Mix up
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New
To
ols
Approaches
Stan
dard
sE
Q
P
S
REGULATORY
SCIENCE
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Safety Efficacy Quality
D R U G
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Pre Marketing Review Inspection Post Marketing
Evaluation
Challenges
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The Regulatory World is highly complex
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Science of Regulation
Innovation
Safety
Reas
onab
le
Bal
ance
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Science of Regulation
Need justifies Outcome
Benefit Risk
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Science has one language & speaks with logic
Lets enjoy benefits of science
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Doctor
Driver
Technician
Manufacturing facility
PharmacistAll require a license to work/practice
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Harmonization saves Resources
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Harmoniz/sation Works
ICH
Japan
EU
ICH
USA
Observers: WHO & Canada
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Balance is required between
Fast Access
Sovereign interest
Western Medicine
Economical Interest
Innovation
Safety
Globalization
Alternative Medicine
Social Interest
Stewardship
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International Conference on Harmonization (ICH) Philosophy
Identification and elimination of the need to duplicate studies to meet different regulatory requirements
More efficient use of resources in the R&D process, as a consequence
Quicker access for patients to safe and effective new medicines
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Standardized Data Elements
Controlled Vocabularies
Common Format
Outcomes
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Speak same language
Quality, accuracy & consistency
Improve timeliness
CTD/eCTDreduces
delays and costs
Outcomes
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Global Regulatory Initiatives
Joint Inspections
Joint investigations
Mutual Recognition
Data sharing
Memorandum of Understanding
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APEC ASEAN GCC PANDRH SADC
A Bridge from ICH to the world beyond
Openness and Transparency
Regional Harmonization Initiatives
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International Compatibility
Way to move forward
GlobalizationRegulatory burden
Innovation and Risk
Capacity and Capability
TI
ME
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Error
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Models of Projects (Example)
Brand Name Analysis
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Sound and look alike……
Amaryl
Reminyl
Amaryl
Reminyl
Celebrex
Cerebyx
Celebrex
Cerebyx
Omacor
Amicar
Omacor
Amicar
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Intelence (Etravirine) TabletsLetters in NameINTELENCE
Scripted may appear as
Spoken may be interpreted as
I e. L any voweln v, r, s, mt f, r, x de i, l any vowell b, e, hc a, r S
Look a like and sound alike letters
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Relative Scale of Concerns
N
G
B
S E Q
S E Q
QES
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Pre-Market Compliance Post-Market
G
B
N
SafetyEfficacyQuality
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Equal voice
Consistency & Uniformity in decision
Question based Review & Critical Thinking
Organizational Approach
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Learn, De-learn & Re-learn
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Thanks