Subjects - Business

Documentation is an important task in the organization.

Those who ever watch television ser

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

ies like CSI know that documentation is important. Documenting the crime scene is one of the

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

Examples of combination products may in

first steps in solving a crime. In this step every details is pictured and or described, but

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

also during the process, every remark from witnesses or suspect s in the crime-scene is ful

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

y documented. The goal of doing this is very simple; by documenting data and information dur

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

Combination pro

ng such a process every user or agent who is involved is able to participate in solving the

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

crime. The better the documentation, the higher the chances that a crime gets solved.

Unfor

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

unately this is not what we see when looking at the television because documentation o itsel

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

f is time consuming and perceived to be boring.

Also in “normal” organizations the activity

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

of documenting is quite important. Think about a call center of a large bank where under nor

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

al circumstances there is a single assignment of agents to a client, it could happen that th

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

Following aspects would a

e client calls when the dedicated agents is not around. Leaving a note in whatever form is t

dd to the challenges in developing combination products:

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

an most adequate. This is a normal example but there are many others.

The main point behind

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

this documenting-issue is that teamwork is more than working with others in a team. Leaving

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

a note is rather easy to recognize as a cooperative action; you do something for someone els

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

. In the case of the call-center you know who the other is.

In may other cases, like the do

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

Professional from academic institutions, pharmaceutical industries, health care indust

cumentation of the crime scene, there is no direct or visible link to your documenting the s

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

ene and others using it. One moment ten people could work on the case and some other moment

.

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

one or fifteen. You do not always (have to) know them.

What must be clear is that without d

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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Subjects - Teamwork And The Importance Of Documenting

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