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...In many situations we act without even knowing why we act the way we do...This is no longer desirable whe

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

n your organization is changing too often...Knowledge Management is (amongst other aspects) about making the “p

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

Examples of combination products may in

ivate” knowledge “publicly” available...So that you can bridge the Knowledge Gap...But your organization was no

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

t used to this. Different teams applied different principles...And now what?

How to address this new set o

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

principles so that knowledge management is adopted in the primary process?

When existing employees and manage

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

Combination pro

ent get new tasks and when the environment is changed, you cannot longer rely on old knowledge patterns. “How w

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

as it, that we did this before? And why doesn’t this work no longer?”

Everybody “knows” how the previous organ

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

zation of knowledge was arranged. In the former setting it was not about people, it was about names: rather tha

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

addressing product specialist X, service desk operator Y or Sales agent Z, it was about John (knows al about p

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

roduct A), Debby (knows how to handle difficult clients, pass it thru her), and Ben (that can only be done by h

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

m).

In the primary sales process, knowledge was not an issue. The organizing rule was – let the "best" (wo)man

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

Following aspects would a

solve it.

Knowledge management is inherently correlated with the way you organize. If you organize in a compet

dd to the challenges in developing combination products:

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

itive way, you will isolate knowledge, you will favour unequal distribution, but most of all you will make the

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

rganization inflexible. Little incidents (this number one salesman is leaving...) will have a big impact.

New

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

rinciples then? And how to apply them?

Your company is not only supported by a primary process of isolated ele

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

ments. It is the infrastructural glue that takes care that all areas communicate. You can do this only by balan

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing the activities in the right way; individual bonuses are alright, only if they are accompanied buy team targ

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

ts. To do that you need to find a shared goal. And sharing knowledge could be one of it.

Once you have address

.

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

ed this human factor, than you might start to think about infrastructure and systems. Although very helpful, al

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

Companies that provide selfless information through particip

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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A pre employment screening usually involves some basic investigation. The most important and common screening is for the authentication of the data in the resume. Many applicants have fake job experiences in their resumes. This might make the resume look attractive but might prove to be harmful to the applicant if the results turn up that the resume has been falsified. Many people expect the employers to take the resume at face value. Of course, a good resume does provide a good impression but if it is falsified, there could be no chance that the employer would consider the candidate.

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Answers - How to Know What You Know (3)

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