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E-Folder - Knowledge Management - Capturing Quality As It Comes In
Knowledge management can be done in two ways, codification (recording informa
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
tion in the form of training modules, manuals etc.) and Training and developm
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
nt (to pass on that knowledge). Most organisations these days are quite good
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
at managing knowledge in general, many have their processes mapped out and te
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
hnical information all noted down in defined training modules.
Some, on the
Some, on the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
other hand seem to be missing a trick. Particularly if they have an active i
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
flux of staff coming into their organisation on a regular basis
I used to wo
I used to wo
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
k in a call centre where our style was very much "We know the business and we
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ll train them in our way" and some of the time, it worked. But what we faile
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
d to realise (myself included) was that as well as the vast amount of knowled
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e we already had, there was also a lot more that we were unaware of still com
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ng in to the organisation.
Particularly in industries such as call centres w
Particularly in industries such as call centres w
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ere employees tend to do "the circuit" of working in numerous different centr
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
es, they amass a much wider knowledge base "wider world view" than an interna
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
individual could ever dream of and rather than just merely trying to cram mo
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
e information into a new start. Perhaps we can look at what we can draw out
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
oo.
This can be on the job at hand, maybe what training and experience they
This can be on the job at hand, maybe what training and experience they
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
have had else where, or drawing on past experience. This not only empowers t
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
e new start and makes them feel valued but it also gleans some potentially vi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
al information and knowledge which can then be codified for the benefit of al
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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