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Printable Handouts
Navigable Slide Index
Topics Covered
- Noncommunicable diseases
- Quality by design approach
- BioRAM
- Process validation stages
- Data integrity, ALCOA+
Talk Citation
Charoo, N.A. (2024, August 29). What I do: technical advisor [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved November 21, 2024, from https://doi.org/10.69645/DRFG1681.Export Citation (RIS)
Publication History
Financial Disclosures
- There are no commercial/financial matters to disclose.
A selection of talks on Pharmaceutical Sciences
Transcript
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0:00
Hello everyone,
my name is Naseem Ahmad.
0:06
I am here today to
talk to you about
my professional
journey in relation to
my modest contribution
in promoting
pharmaceutical research
and manufacturing
in the Middle East and Africa.
0:18
'Make it in the Emirates'
was launched in 2021.
The strategy of
the UAE Ministry of Industry
and Advanced Technology is
a comprehensive
national program that
aims to drive industrial
growth in the UAE by
boosting its GDP contribution
from 133 billion dirhams to
300 billion dirhams by 2031.
Part of this vision
is a push for
local manufacturing to
improve self-reliance.
0:49
Noncommunicable diseases kill
almost 41 million
people each year
which is equivalent to 74% of
all deaths occurring globally.
Of all the noncommunicable
disease deaths,
77% are in low and
middle-income countries.
The main types of
noncommunicable diseases are
cardiovascular
diseases, cancers,
chronic respiratory
diseases, and diabetes.
These four groups of
diseases account for
over 80% of all premature
deaths occurring due to
noncommunicable diseases.
1:28
The product mix
presented in this slide
reflects the UAE's vision of
self-reliance and
disease burden.
1:37
To achieve these objectives,
we develop our products
in our state-of-the-art
research and development
facility using
the Quality by Design approach
which is a patient-centric
approach (QbD).
In the QbD paradigm,
the quality target
product profile embodies
the overall objectives of
the product development program
which include patient safety
and product efficacy.
Critical quality attributes,
which are physical,
chemical, biological,
or microbiological
properties of a product
are identified from the
quality target product profile
and prior experience.
This lays the foundation for
formulation and process design.
Risks to critical
quality attributes are
identified by risk assessment.
Product and process studies are
subsequently performed to
gain knowledge
about these risks.
Strategies are devised to
eliminate or
mitigate these risks
and meet the objectives set in
the quality target
product profile.
This culminates in design
space construction
and the formulation of
a control strategy.
For a product to meet