Digg It - Business

Power Teams work well when there is an element of trust and integrity. Holdi

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

ng the information for a project is certainly one of those areas where trust

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

Examples of combination products may in

is prominent. No one should own the information but all need to have unlimit

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

ed access to it. Even then, the information needs to be stored and there sho

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

ld be only one or two administrators that look after it. This may seem like

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

Combination pro

a lot of work but the ownership issue can cause problems unless defined ahea

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

of time. If the information is stored in a database, you may want only one

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

or two people to do updates or additions and deletions. If you add too many

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

eople to the administration of the data, there can be duplication of effort

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

and even worse, deletion of data that is crucial to the success of your proj

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

ct.

Information ownership should not be a matter of territory. It

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

Following aspects would a

should, however, be a matter of control. One person on the project needs to

dd to the challenges in developing combination products:

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

be responsible. This does not mean that others will not have access; it simp

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

y means that they will have limited abilities to manipulate the data. In oth

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

er words, they may only be allowed to read the information, add to it or mak

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

changes. They will not be allowed to delete anything, only the administrato

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

Professional from academic institutions, pharmaceutical industries, health care indust

r should be allowed to do that.

Most projects have data, reports

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

nd other things that must be prepared for the company buying the services. I

.

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

f you are working with a Power Team, put together a plan of responsibilities

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

Companies that provide selfless information through particip

before proceeding. This plan should also include who is responsible for what

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/2078/diggit-Power-Teams-and-Information-Collection.html">Power Teams and Information Collection</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/2078/diggit-Power-Teams-and-Information-Collection.html]Power Teams and Information Collection[/url]

Trying to keep everyone informed and up to date by sending a blizzard of e-mail doesn't work, and just increases people's stress levels. Here's a better way.

Operating a small business takes a certain level of discipline and understanding. This is because it small business is like a child in that your decisions can either help it grow and blossom or destroy it. Let's consider just a few of the positions in a small business that need filled usually by the owner.

If airline travel to Denver is in your near future, you might be considering using a Denver airport shuttle service to get you to and from the airport to your home, hotel,

Tags

Links

Digg It - Power Teams and Information Collection

Related Articles: