Advice You - Business

A Group Decision Support System (GDSS) offers a viable and attractive alternative over th

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

e traditional, oral meeting environment and in many situations, has revolutionized the co

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

Examples of combination products may in

ncept of meetings. Interest and research in the area of GDSS is growing due to the system

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

s' ability to enhance group productivity, Marketing Strategies and interaction. Group Dec

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

ision Support System is a system that combines communication, computing, and decision sup

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

Combination pro

port technologies to facilitate formulation and solution of unstructured problems by a gr

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

oup of people. There has been a general lack of consensus about what exactly constitutes

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

Group Decision Support System, however. GDSSs have evolved beyond their original emphasi

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

s on decision-making, and new terms such as Electronic Meeting System, Computer Supported

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

Collaborative Work and Groupware are also used to describe the technology.

Most GDSSs a

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

re designed to help groups become more productive by supporting the exchange of ideas, op

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

Following aspects would a

inions, and preferences within the group. Group participants using a typical GDSS may be

dd to the challenges in developing combination products:

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

seated at microcomputer terminals arranged in a semi-circle or U-shape and connected via

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

a Local Area Network (although alternative meeting styles are also available as discussed

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

in the following section). A group leader or facilitator stands in front of the group and

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

controls the meeting by starting and stopping the software, preparing questionnaires, an

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

Professional from academic institutions, pharmaceutical industries, health care indust

d performing other administrative tasks. Meeting participants communicate with each other

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

and the facilitator via a computer network and participate in brainstorming, voting, ran

.

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

king, and other procedures to accomplish group tasks.

In addition, the software may prov

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

Companies that provide selfless information through particip

ide access to databases, models, statistical analysis packages, and a host of other tools

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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