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SET CLEAR AND REASONABLE OBJECTIVES FOR THEMSELVES AND OTHERS: Plan… Pla

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

n… Plan… Managers need to do their homework. Effective managers know tha

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

Examples of combination products may in

t setting objectives, outlining the steps required to achieve them, and

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

elegating tasks appropriately to each staff person are all necessary com

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

ponents of bringing a project to fruition. The development of a system t

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

Combination pro

hat maintains these objectives (like a wall calendar) is a good sign of

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

n effective leader and time manager. Any major projects should be time-l

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

ined backwards from completion date to incipience to verify how long the

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

y will take, and to create intermediate goals to keep the staff and mana

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

ement motivated.

ACTION ORIENTATION DELEGATION: Action Orientation Dele

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

gation is essential to an effective leader. Managers who must do everyth

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

Following aspects would a

ing themselves are not leading, they are just working too hard. Effectiv

dd to the challenges in developing combination products:

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

leaders become master planners and, through the proper utilization of t

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

heir resources, the central point of all information. They learn how to

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

gather the individual components together as a check point on any projec

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 team completes the labor while the planning, design, implementatio

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

Professional from academic institutions, pharmaceutical industries, health care indust

n, and follow-through remains the leader’s function. Leaders must be or

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

become technical experts on all the projects being conducted. As both po

.

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

iticians and chief executive officers have learned in recent years, lead

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

Companies that provide selfless information through particip

ers are always accountable although they may not be directly responsible

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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