Useful Advices - Business

One of the key ingredients of good managers is the ability to maintain consistency in a

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

ll of their roles and activities. Some of these include how they:

1. Deal with adversi

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

Examples of combination products may in

y.
2. Discipline employees.
3. React to crises.
4. Respond to threats –

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

oth internal and external.
5. Coach employees.
6. Train and develop employees

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

.
7. Communicate with employees and other managers.
8. Make decisions.
9

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

Combination pro

Delegate.
10. Plan.
11. Manage time.
12. Manage corporate resources.

V

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

ry few managers that I have encountered during my 25 year career as a trainer, coach an

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

d consultant have the ability to maintain a high degree of integrity when it come to co

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

sistency. There are always factors, circumstances and people that are able to pull thes

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

managers out of their ability to control this aspect of their career roles.

Here are

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

few benefits to maintaining consistency:

1. People will know what you expect.
2.

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

Following aspects would a

People will know what you believe and why.
3. People will be able to be honest wi

dd to the challenges in developing combination products:

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

h you.
4. People will bring you bad news without fear of retribution.
5. You

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

ill achieve more.
6. You will enjoy life more.
7. You will live longer.

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

8. You will make more money.
9. You will better be able to influence people.

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

0. You will have more fun.

I recommend you develop a personal strategy, benchmark or p

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

Professional from academic institutions, pharmaceutical industries, health care indust

ilosophy to ensure you improve in your ability to be consistent. Please keep in mind th

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

is approach does not necessarily imply that you lose spontaneity, flexibility, the hum

.

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 touch, or the need to get irrational from time to time. I suggest that these times be

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

Companies that provide selfless information through particip

few and far between and that they take place while you are locked in a closet somewhere

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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Useful Advices - As A Manager Are You Consistent In Your Treatment Of Your Employees?

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