Digg It - Business

As a supervisor, your primary responsibility is to make sure your employees are performing as exp

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

ected. But supervising takes time, which you may not have in abundance. So what do you do?

Commu

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

Examples of combination products may in

icate.

Yes, talk with your employees, both individually and as a group. That may not sound like

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

time-saving method, but I guarantee you that early communication can eliminate or lessen the nee

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

d for much more time spent down the road.

If you make it a habit to communicate frequently, you'

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

Combination pro

l discover it takes less and less time. I have found it's best to have one-on-one meetings for 10

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

15 minutes each week. If you have trouble figuring out what to say, here are some ideas of what y

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

ou can ask your employee:

What did you accomplish this week?
What do you have p

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

anned for next week?

Do you have any suggestions for changes or improvements in the way

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

he work is done or for the department/company?

You can also use this time to reinforce r

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

cent positive behaviors or to correct negative behaviors. It may be a little uncomforta

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

Following aspects would a

ble at first but, once your employees understand that you are interested and listening, they (and

dd to the challenges in developing combination products:

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

you) will gain more confidence in sharing information. In addition, have a brief weekly meeting w

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

th all your employees together. This is a great time to update them on the status of the workload

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

, special projects on the horizon, or to brainstorm ideas about how to improve one of your proces

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. As an employee once told me, "My supervisor hired me for my expertise, but never asks my opin

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

Professional from academic institutions, pharmaceutical industries, health care indust

on." Don't make this mistake and take a chance of losing good employees!

You will find that your

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

employees stay more motivated and engaged in their work when they feel they have an active role

.

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

n the process.

These friendly meetings also open the door for easier communication about perform

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

Companies that provide selfless information through particip

nce issues.

This is the first 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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