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Most of the challenges in knowledge management primarily stem from the types of knowledge reuse situations and p

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

urposes. Knowledge workers may produce knowledge that they themselves reuse while working. However, each knowled

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ge re-use situation is unique in terms of requirements and context. Whenever these differences between the knowl

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

edge re-use situations are ignored, the organization faces various challenges in implementing its knowledge mana

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

gement practices. Some of the common challenges resulting due to this and other factors are listed below.

Data

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ccuracy: Valuable raw data generated by a particular group within an organization may need to be validated befor

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

e being transformed into normalized or consistent content.

Data Interpretation: Information derived by one grou

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

p may need to be mapped to a standard context in order to be meaningful to someone else in the organization.

Da

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ta Relevancy: The quality and value of knowledge depend on relevance. Knowledge that lacks relevance simply adds

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

complexity, cost, and risk to an organization without any compensating benefits. If the data does not support o

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

truly answer the question being asked by the user, it requires the appropriate meta-data (data about data) to b

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

e held in the knowledge management solution.

Ability of the data to support/deny hypotheses: Does the informati

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

on truly support decision-making? Does the knowledge management solution include a statistical or rule-based mod

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

el for the workflow within which the question is being asked?

Adoption of knowledge management solutions: Do or

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ganizational cultures foster and support voluntary usage of knowledge management solutions?

Knowledge bases ten

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

to be very complex and large: When knowledge databases become very large and complex, it puts the organization

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

in a fix. The organization could cleanse the system of very old files, thus diluting its own knowledge managemen

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

t initiative. Alternatively, it could set up another team to cleanse the database of redundant files, thus incre

.

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

asing its costs substantially. Apart from these, the real challenge for an organization could be to monitor vari

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ous departments and ensure that they take responsibility for keeping their repositories clean of redundant files

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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