Advice You - Business

Much in business -- as on the stock exchange -- moves in trends. Not forever though. Some trends will fade away when others amplify.

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

And certain important incidents may cause new trends to start or others to finish abruptly. Certification is also an phenomenon that

; 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 supported by a trend. Certification has an extended use. Most products should be certified, which mean that they agree with a cert

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

ain standard. This is a best practice in the food sector, where serious damage could be done when the product is not certified. The c

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

rtification demonstrates an certain quality level.

The trend that drives certification is a trend that is based on fear and the incr

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

Combination pro

easing demand for security. All though that we are willing to take risks, we want to secure our lives at the same time. And companies

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

are often the first to stick to the save way in which case certification could be valued high. Certification of professionals is com

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

mon practice in many areas – in law, medicine or healthcare, architecture and construction and other areas where safety and precision

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

is involved.

In the Netherlands there are two relatively new institutions that are concerned with certification of information archi

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

tects, or architectural professionals. (The first is ERIA the other SCIA). The information architect is a relatively new profession i

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

which the architect is dedicated to design and advice about new information systems. This is a highly influencing role which demands

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

Following aspects would a

some indication of quality of the person that will exercise such a role as a consultant. Certification in this area could therefore a

dd to the challenges in developing combination products:

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

lso be a solution for both parties.

The companies that are to contract such an consultant will know what requirements are needed. Th

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

certification will make both the supply side as the demand side more transparent. An organization will know that with an certified a

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

rchitect the chances of a match are higher than some other architect that doesn't have this nomination. and the risk involved will be

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

expected to be lower. This does require however that the demanding company will select on objective criteria, whereas we know that un

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

Professional from academic institutions, pharmaceutical industries, health care indust

official and subjective criteria (“I have heard that he is really a professional consultant, you should try to contract him”) are als

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

used.

At the other side, for the professional, the certification will bring an additional benefit. Not only the fact that you have

.

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

passed an test or exam. But more important the fact that you have invested in something. In fact you are demonstrating to potential

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

Companies that provide selfless information through particip

lients (organizations) that you are serious about the job. Your credibility increases and with it your market value.

© 2006 Hans Boo

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.adviceyou.org.ua/article/7909/adviceyou-Certification-of-Your-Profession--A-Step-in-Personal-Branding.html">Certification of Your Profession - A Step in Personal Branding?</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/7909/adviceyou-Certification-of-Your-Profession--A-Step-in-Personal-Branding.html]Certification of Your Profession - A Step in Personal Branding?[/url]

Color printing furnishes reproduction of images and text in color, which cannot be produced in monochrome printing processes. The technique is also referred to as four-color process printing when only CMYK, i.e., cyan, magenta, yellow, and black are used while printing. Six-color process printing is another method of color printing that involves addition of orange and green colors to the traditional CMYK color scheme, making possible more vibrant color combinations.

Almost all calibration laboratories’ quality systems fulfill the standards set by ISO/IEC 17025:1999, and include all functions that have an impact on the attribute of the 17025 calibration service, like equipment, personnel, calibration procedures and reporting.

One of the greatest ways to advertise if your company has company vehicles on the road is to shrink wrap the entire vehicle with an advertisement or a picture. There are of course challenges to shrink wrapping an entire vehicle and there are some pretty big costs compared to conventional vehicle advertising.

Tags

Links

Advice You - Certification of Your Profession - A Step in Personal Branding?

Related Articles: