Advice You - Business

Do you dream of becoming the CEO of your organization? Even i

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

f you are at the bottom tier and your company employs more th

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

Examples of combination products may in

an hundred thousand employees? Do you think that you will one

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

day become the CEO of your organization? Is it only a dream o

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

r you have the ability? Why not quiz yourself and find out no

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

Combination pro

?

Do you know about the responsibilities of a CEO? Let us di

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

scuss about them and quiz your knowledge about that.

1. To m

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

nage the organization

2. Co ordinate all the departments

3.

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

Decide the goals

4. prepare and approve the strategy for ac

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

ieving the goals

5. Prepare the organization for the future.

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

6. get the best out of human resources

7. Improve efficien

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

Following aspects would a

cy. Bring down the cost and increase the profits

8. Plan for

dd to the challenges in developing combination products:

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

new product launches

9. Keep ready for the competition

10.

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

Keep shareholders happy

11. Manage by anticipating the probl

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

ms

12. Follow all the legal requirements

These are some of

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

the functions of a CEO. If you want to become the CEO of your

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

Professional from academic institutions, pharmaceutical industries, health care indust

organization in future think about all these functions and pr

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

epare yourself mentally and gain knowledge to achieve the obj

.

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

ctives. Dreaming is good. When concrete actions that is bette

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

Companies that provide selfless information through particip

r and only then one support the dreams can realize the dreams

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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