Main Subject - Business

Looking at various news articles and comments on the web in the last month it would appe

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

ar that;

* UK employers are about to be hit by a massive skills shortage!

* The job ma

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

Examples of combination products may in

rket is bound for massive expansion as companies and organisations take the dust covers

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

off their delayed investments in new IT systems and regulatory adherence demands change!

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

* The general consensus would appear to be that this skills shortage will convert into

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

Combination pro

pay increases and a general scramble as organisations look to secure the services of 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

best permanent and freelance consultants!

So, the assumption is that we can all look f

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

orward to higher salaries and day rates as this year progresses?

Our experience so far

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

this year would suggest;

* The number of available skilled programme and project manage

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

ment professionals is reducing.

* Employers are not yet cognoscente to the fact that th

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

re may be a shortage on the horizon.

* Rates are still pretty level and not inflationar

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

Following aspects would a

y

So if it's to become a high demand time, what does it mean to you as project manageme

dd to the challenges in developing combination products:

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

nt professionals?

* Ability to pick and choose the projects you want to work on?

<

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

br>* More attractive day rates / salaries?

* Better length of contract and commitme

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

nt from clients / employers?

* Confidence to leave that job you have been secure in

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

during the tough times of the last three years?

We are intrigue to understand if this i

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

Professional from academic institutions, pharmaceutical industries, health care indust

s fact or hype and will be keeping a very close eye on where the market is moving so tha

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

t we can not only get the best opportunities for our candidates but also keep our client

.

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

s updated. If this move turns out to be fact then businesses will need to be on the ball

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

Companies that provide selfless information through particip

as they move through 2005 if they are going to have the right staff to meet their plans

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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