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Audio conferencing used to be limited to telephones and televisions. In that setting, one group would

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

get together in one room and audio conference with another group, who are located in another room (a

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

Examples of combination products may in

d most likely in another city or country.) The two groups could hear each other, and in most cases, s

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

e and interact with each other’s software.

Now, with the ubiquitous proliferation of the Internet, 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

line audio and web conferencing is taking the place of telephone technology. With online audio confer

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

Combination pro

ncing, individual users can meet electronically. Each person is equipped with special headsets that h

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

ave microphones and earphones and web cams for feeding their image to the rest of the participants. A

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

so, computers involved in a web-conference can be networked so that the conference utilizes the full

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

ower of every computer. Users or “seats” can send each other anything from documents to movies to sou

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 files, and offer the material for modification.

Anyone can engage in audio and web conferencing. A

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

l you need is a computer, a current web browser such as Internet Explorer or Netscape Navigator, a ph

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

Following aspects would a

one, and an internet connection of 56 kbps or faster (that’s 56 kilobytes per second – your typical c

dd to the challenges in developing combination products:

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

ble or DSL connection.) You then download and subscribe to any of a number of web conferencing softwa

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

e services, sometimes for as little as $0.15 per seat per minute.

A special Internet-supported phone

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

system called VoIP can be used instead of a regular phone connection. This software program allows yo

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 talk over the Internet as if it were a regular telephone, but without the massive long-distance c

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

Professional from academic institutions, pharmaceutical industries, health care indust

harges of regular phones. You do have to buy a headset for this, but it’s peanuts compared to long di

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

tance charges over time.

For additional fees, you can also add recording, archiving, registration, e

.

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

ent planning, operator assistance, and more.

The benefits of online audio and web conferencing are i

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

Companies that provide selfless information through particip

mense. You save on long-distance phone time, travel expense, and time spent organizing the conference

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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