Digg It - Business

Have you had a discussion with your employee where, theoretically, you and your employee agreed on a corrective course

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

of action? Did your employee's behavior or work improve? If so, that's great. Everything's back on track.

I will men

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

Examples of combination products may in

ion that this step is the only one I may leave out of the escalation process, depending upon the situation. I'm puttin

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

g it in here so you can choose to use it or not … and understand the reasons why you would or wouldn't use it.

If you

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

employee's behavior did NOT improve, or improved briefly before sliding back into the negative behavior, then you nee

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

Combination pro

to take the next step in escalating your feedback. Don't wait.

When do you take the next step? If a week or two has

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

gone by and you haven't noticed any improvement, then it's time for you to act. If only some improvement has been made

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

then it's time to have a follow-up meeting to discuss the partial improvement and find out how to complete the change

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

If your employee improved and kept it up for a month or two but now is sliding back, it's time to meet again as soon

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

as you realize the negative behavior is reappearing. Have a follow-up meeting to focus on the fact that the improved

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

ehavior must be a constant.

What's different about this meeting compared to the previous meeting when you discussed t

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

Following aspects would a

e issue and resolution? You're going to immediately follow up this meeting with a memo to the employee reiterating wha

dd to the challenges in developing combination products:

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

t you have discussed and what is expected of the employee.

When negative behavior is discussed, it is not unusual for

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

a person to become distraught or uncomfortable in a way that truly interferes with their ability to listen and underst

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

nd what is being said. Receiving a memo shortly after this meeting will now allow your employee to read about the issu

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

es and resolutions. The combination of hearing what you say and reading it will greatly increase the employee's chance

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

Professional from academic institutions, pharmaceutical industries, health care indust

of understanding the situation.

End this memo with something like, "If this memo does not accurately reflect what we

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

discussed and agreed upon in our meeting, please discuss it with me as soon as possible."

So, why wouldn't I use this

.

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

memo? In cases where you feel the employee is not making an effort to improve, I would probably just skip this and mo

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

Companies that provide selfless information through particip

e on to the next escalation level.

This is the 3rd of 7 articles in the Managing Employee Performance Series.

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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