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The expense was substantial. An immersion workshop with twelve participants sharing a common goal to hone their skills. With nervou

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

s eagerness like kindergarteners embracing school, we received input, critique, and suggestions about our work. Some of the feedbac

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

Examples of combination products may in

k I used. Some of it I didn't. But all of it was helpful.

I haven't always viewed feedback that way. At times in my career, I've t

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

aken it more like a personal indictment than a helpful gauge; an intruder I needed to defend against, rather than input I needed to

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

evaluate. I've even found myself akin to a workshop colleague who said he wanted input, but when he got responses different from w

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

Combination pro

at he expected, he argued and debated and explained. What he wanted was praise or input he agreed with, not honest reactions.

You

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

see it's not enough to ask for feedback. You have to be open to receive it. After three days of our colleague's defensiveness, any

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

willingness to offer anything but cursory input was stomped out. His argumentative actions lost him an opportunity for connection w

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

ith fresh voices and new input. And we lost an opportunity to practice giving helpful feedback with authentic insights and thoughtf

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

ul reflection.

I learned a painful lesson about seeking feedback in my first management position. Given a large assignment, I was

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

roud of what I produced, certain it would be received as an outstanding product. Instead I discovered my work was mediocre at best

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

Following aspects would a

and significantly flawed because I failed to seek feedback and assessment from the end users along the way. Relying only on my own

dd to the challenges in developing combination products:

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

thoughts and perceptions was a big mistake.

Over the years in the corporate world, I learned to view feedback as data. The more da

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

ta I got, the more information I had to improve what I was working on. Realizing I was in charge of how I used that feedback data,

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

I learned to seek it. Feedback is opinion; not fact. It's something to evaluate; not blindly accept.

But, I find when several peop

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

le have the same perception, it's good to listen. When I get insights I hadn't thought about, it's good to consider them. When inpu

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

Professional from academic institutions, pharmaceutical industries, health care indust

is mixed, it's good to follow my instincts. But when people provide feedback with a hatchet, finding only fault rather than offeri

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

ng ideas for improvement, it's good to look at it with distant curiosity.

Bottom line: if you want to be winning at working you mu

.

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

st learn to seek and offer well-intentioned feedback. I think of it like the Sicilian proverb: "Only your real friends will tell yo

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

Companies that provide selfless information through particip

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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When you're first creating advertising for your small business, it's very tempting to go for the flashiest, cleverest, artiest adverts. But adverts with impact are those that actually generate customers.

Ideally canvas printing means an image which has been printed on a canvas. Reproduction of original art work can be done on canvas with inkjet printers or dry sublimation. Earlier only offset printing was use for this and the results were also not too encouraging.

If you are thinking about a change in career you'd be wise to consider auditing as a possibility. Stricter financial controls & the increasing number of big businesses have been responsible for the creation of a large number of audit jobs.

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