Just Other Articles

It’s something probably everyone in training or who has trained someon

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 has come across at some point or another, an occupational hazard so

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

Examples of combination products may in

to speak! Most people (And I’m including myself on this) take it a li

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

tle personally to begin with. You’ve geared up for your training sess

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

ion, prepared well, stood at the front of the room with a big welcomin

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

Combination pro

smile on your face only to faced with a sea of unfriendly glares stra

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

ight back at you. Or, the ultra friendly “Do we have to be here?” or

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

How long is this going to take?” Ouch! And after we try so hard! Aft

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

er all, we are trying to help people, surely they should be grateful!?

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

I jest of course but there are you few ways you can survive the first

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

five minutes difficult behaviours

First comments are not for you: Wh

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

Following aspects would a

en a participant comes in to the room and immediately fires a comment

dd to the challenges in developing combination products:

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

ike the ones above, it is almost never aimed it you, it is usually bec

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

ause of an unrelated issue such as issues with their manager, general

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

orking environment or home issues.

My answer to a “Do we have to be h

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

ere?” has always been “Certainly not, I’d like you to be here, why do

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou feel this way?” Invariably, the real issue will come out and then I

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

can work at the base issue (which is usually something really simple,

.

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

with an equally simple solution!) Works every time, it’s a clich? and

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

Companies that provide selfless information through particip

it may take some time to get used to it but, don’t take it personally

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.justotherarticles.org.ua/article/34649/justotherarticles-Dealing-With-Difficult-Participants--The-First-Five-Minutes.html">Dealing With Difficult Participants - The First Five Minutes</a>

BB link (for phorums):
[url=http://www.justotherarticles.org.ua/article/34649/justotherarticles-Dealing-With-Difficult-Participants--The-First-Five-Minutes.html]Dealing With Difficult Participants - The First Five Minutes[/url]

Digital signage puts marketers in charge of when and where their messages influence shopper.

10 minutes mental preparation can make the difference between landing that plum job, or another rejection. This easy technique shows you how to be a peak interview performer when it really matters.

Creating national expert status for your yourself gives you a tremendous competitive advantage. Find out how to get a celebrity edge using publicity and appearing on radio and TV show, and in Magazines & Newspapers.

Tags

Links

Just Other Articles - Dealing With Difficult Participants - The First Five Minutes

Related Articles: