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There are legal risks and potential liabilities involved with using 360 degree feedback, although you can reduce your risk by using 360 feedback correctly.

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

The risk of a law suit associated with 360 increases when you use it for determining promotions, bonuses, pay raises and the like. It's much less when the O

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

Examples of combination products may in

LY purpose you use 360 for is to improve performance. In other words, use 360 as a replacement for traditional performance appraisals, and you have the pote

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

ntial for legal problems.

For the most part, the risks associated with performance appraisal in general, and 360 specifically have to do with whether the i

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

formation used is valid, job related, accurately measures employee performance, and is not discriminatory against any protected classes. The major issue has

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

Combination pro

to do with the potential for someone from a designated minority group who has been passed over for promotion, to accuse the company of discrimination. If 3

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

0 is used to determine who was promoted, AND, the company cannot demonstrate the validity, or relevance of the 360 process, that's where problems lie.

The

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

employee can take the company to court, or to the EEOC or other human rights complaints boards.

In practice, most 360 systems use rating systems that are v

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

gue, and the raters themselves are given no training to ensure their ratings are valid or reliable. In practice, most 360 systems rely on ANONYMOUS feedback

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

-- that is that the feedback given is not linked to any specific person. and the recipient does not know who rated what at what level.

The latter point pu

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

s 360 in a completely different light, as compared to other rating systems that have an identifiable manager as the source of the feedback. How can you prov

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

Following aspects would a

that the feedback and information used to determine who got a promotion, is valid, relevant and non-discriminatory, when you can't even identify WHO provid

dd to the challenges in developing combination products:

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

ed that information?

Of course, with legal issues, you never know what the courts will decide in any specific case, even if there is some precedent going o

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

e way or another. It is safe to say that if you use 360 degree feedback to replace traditional performance appraisal, your risk of being sued, and the risk

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

of losing the law suit increase. However, there's an alternate opinion.

Susan Heathfield, who writes about HR issues (but is also not a lawyer), suggests t

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

e following:

When feedback comes from a number of individuals in various job functions, discrimination because of race, age, gender, and so on, is reduced.

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

Professional from academic institutions, pharmaceutical industries, health care indust

The "horns and halo" effect, in which a supervisor rates performance based on her most recent interactions with the employee, is also minimized.

Perhaps,

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

s with any legal issues, consultation with a qualified attorney is warranted, remembering that legal problems occur as a result of HOW something is applied,

.

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

so the details are important.

(c) 2007, Robert Bacal, Bacal & Associates. You are welcome to "reprint" this article online as long as it remains complete

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

Companies that provide selfless information through particip

nd unaltered (including the "about the author" info at the end) all links are made live, and this copyright notice and indication of authorship are included

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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Nobody wants to here somethig negative about their children. Entrepreneurs become emotionally vulnerable when they bring their children into the workplace and under the scrutiny of others.

Are you not frustrated when you see your materials being ignored and trashed? Isn't it frustrating that what you had exerted had ended up this way. Well for sure this is a business downfall, if all of your exerted efforts had been ignored and trashed out. So why not think of a good strategy that will make you stand out and noticed.

If you have plans to earn and have little to no cash to start, expect it to take time to grow and learn. The key is patience. As they say steady wins the race!

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