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There are increasingly two schools of thought (we're sure there are probably 2002): one for and one against Appraisals. And in both, the bottom line still

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

is that they will cost your company money if not handled well. As we know, in vast numbers of cases they aren't.

Although the appraisal format may be key,

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

Examples of combination products may in

the best procedures in the world won't really be effective if the person running the appraisal isn't handling it efficiently, professionally and with long-

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

erm care involved.

Performance appraisals are almost always a one or two-times a year process rather than something that is a daily part of a manager's jo

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

b. They usually become 'tick the box' exercises that cause a great deal of anxiety on both 'sides' and once they're competed they aren't looked at again ti

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

Combination pro

l the next time.

Difficult feedback gets postponed or sugar-coated, or even worse, lied about on the Appraisal form. A lot of managers don't want to put d

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

wn in black and white that someone's performance has been under par and therefore they (the manager) will be responsible for that person not getting a pay

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

increase or promotion.

In turn, appraisals can also lack objectivity and, therefore, have more personal rather than professional views included which coul

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

be detrimental.

In addition, if everything is focused on the appraisal process then you run the risk of creating anxiety during the build-up and a lack o

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

motivation and productivity as people anticipate the results. In other words, there should be no surprises during an appraisal.

Supposedly only 5% of org

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

nisations say they have satisfactory appraisal processes, but we got that information off the Internet, so I’d take it with a pinch of salt!

A truly good

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

Following aspects would a

Appraisal is actually an agreed summary of what has been happening on an on-going basis between appraisals. If it is left to review twice a year, or quarte

dd to the challenges in developing combination products:

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

ly, all the opportunities to support and guide the employee to improve get missed. People need to be engaged in the idea that managing people - and being m

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

naged - is constant.

Fear, uncertainty, collusion, duplicity, embarrassment, laziness, guilt and sheer incompetence are among the reasons why appraisals a

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

re often not worth the paper they are written on.

One of our clients told us that rather than completely redoing their appraisal process they decided to '

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

ark down' their performance related pay levels: in other words if someone had been scored a 4 (out of 5 levels) they were lowered to a 3. This was because

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

Professional from academic institutions, pharmaceutical industries, health care indust

hey discovered that most managers scored people higher than their performance merited. It was an exercise in trying to get rid of the 'invisible incompeten

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

ce' that the process colluded in.

A great appraisal needs to be fair, objective, two-way, realistic, clear, on-going and specific.

It also needs to be po

.

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

itioned well.

It's easy to shoot yourself in the foot if you place too much emphasis on the actual appraisal process and not on the on-going performance m

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

Companies that provide selfless information through particip

nagement. People will focus on the process rather than the objective, which is to help people develop in to more effective, better managed members of staff

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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