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Are you NICE or do you CARE?

Most people and most managers want to b

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

e nice. After all, it's easier to be nice than to not be nice. But when we talk about being a manager, there is a difference between being nice and being NICE. A NICE manager can be pleasant to be around. They're friendly and helpful and avoid even the most remote semblance to confrontation.

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

Examples of combination products may in

rier New">How do you spot a NICE Manager?

When someone brings them a problem, a NICE manager provides them with a solution.

When

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

a report is late because the employee in question and their spouse went to a movie instead of completing the assignment, a NICE manager understands. After all, it's important to balance work and home.

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

N>When the presentation lacks clarity, or the conclusions aren't supported by the facts, a NICE manager thanks them for their efforts and doesn't dig any deeper.

And when the production numbers for the month are down for the 3rd consecutive month, a NICE manager clearly understands

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

Combination pro

the reasons that are causing the problems and knows that they are not the fault of the employees.

A NICE manager avoids the controversy and confrontation that goes along with employees who are not quite performing up to par. A NICE manager defends their employees regardless of the

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

situation, because there are always extenuating circumstances.

And that's the problem with a NICE manager. They always understand and always relieve the employee of the responsibility.

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

east-font-family: 'MS Mincho'">What does it mean to be a NICE manager?

N - Nothing

I - Inside

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

C - Cares

E - Enough

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

MS Mincho'">Nothing inside cares enough to hold the employee accountable for their own actions.

Nothing inside cares enough to tell the employee when they are falling behind or failing.

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

0pt">Nothing inside cares enough to be willing to upset the employee even if it is for their own good.

Nothing inside cares enough to help the employee achieve everything that they are capable of achieving

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

Following aspects would a

Frankly, being a NICE manager doesn't really help the employee, because it leaves them without any accountability, and it does no good for the manager either, as they now have more work to do.

dd to the challenges in developing combination products:

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

e="mso-fareast-font-family: 'MS Mincho'">Being a NICE manager is a "lose - lose" scenario.

As a Manager, it is your responsibility to the company and to your employees to see that peak performance is achieved. You also have a responsibility to your employee

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

to maximize their talents and growth, to see that they are ready for the promotions that may come their way, and to ensure that they learn the skills to achieve and succeed at higher and higher levels. You owe it to your employees to give them honest feedback on their performance so that they can develop their own skills and prepare for their future. And you can do it all in a positive, reinforcing manner.

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

That's the difference between being a nice Manager versus a NICE Manager.

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

SPAN>Instead of being NICE, I suggest that you CARE.

A Manager who CAREs will coach an employee on a problem, not assume the work for him.

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

Professional from academic institutions, pharmaceutical industries, health care indust

rier New">A Manager who CAREs will communicate with an employee when their work does not meet expectations and coach them until it does.

A Manager who CAREs will identify the talents in their people and help cultivate those talents to even greater levels and coach them in areas whe

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

e they can still develop.

What does it mean to CARE?

C - Coaching

.

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: 0in 0in 0pt">A - Allows

R - Real

E - Excellence <

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

Companies that provide selfless information through particip

:p>

So you have two clear choices. You can be NICE to your employees, or you can CARE.

Which will you choose?

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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