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Managers or supervisors need certain skills and knowledge such as how to delegate, communicate, hire, resolve conflict, and work with difficult

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

people. However the first step for people to become excellent supervisors involves their managing themselves.

Budgeting time multipli

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

Examples of combination products may in

s the results gained each day. Time budgeting means a person can and does know how to deal with interruptions, understand and manage procrastin

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

tion, and learn what to control and what to ignore.

A manager needs to deal with interruptions wisely: Is the interruption necessary, 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 can it be “put off” until another time or indefinitely? Unless a supervisor can say, “Let me think about this and call you back,” or “I’m sor

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

Combination pro

y, but I’m busy right now,” then she and her employer lose. Planning ahead can help avoid interruptions; delegating can keep interruptions dow

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

; setting up an in-office protocol for when and how to handle emergency situations will avoid many interruptions. Being organized will limit 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

any problems. When unavoidable interruptions occur, as they will, a supervisor who can control her reactions and adjust will find such interru

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

tions managable.

Procrastination is another problem that wastes time. Something that needs to be done or finished, but isn’t, shows a lack of

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

elf-management on the part of a supervisor. According to Time Management on BusinessTown.com, we procrastinate for five reasons:

1. We haven’

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

really committed to do the activity.
2. We’re afraid of the job.
3. We don’t place a high enough priority on the job.
4. We don

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

Following aspects would a

’t know enough to do the task.
5. We don’t want to do whatever the activity is.

In all five cases, a manager must find a way to do what n

dd to the challenges in developing combination products:

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

eds to be done, which means self-discipline is necessary. In some situations, finding the right person to do the job required can solve the pro

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

lem.

An excellent supervisor stays motivated and under-control, even under trying and difficult conditions. When others become angry or

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

upset, a manager stays in control. He keeps his eye and mind on the goal, the outcome of his job. Sometimes staying motivated means a supervi

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

or should stop fighting change and find a way to accept it.

Being assertive without appearing arrogant or overbearing means staying und

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

Professional from academic institutions, pharmaceutical industries, health care indust

r control. One man stated that even when he didn’t feel confident, he acted as if he were until he was. Being assertive means feeling confident

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

and behaving positively. Developing good communication and negotiating skills helps one be assertive, confident and successful.

Once supervis

.

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

rs can and do manage themselves then they can in turn be managers of others.

Sources:
1. “Procrastination – UIUC Counseling Center,” www.

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

Companies that provide selfless information through particip

ouns.uiuc.edu
2. “Dealing With Interruptions,” OnlineOrganizing.com
3. “Time Management: Can You Really Manage Time?” BusinessTown.co

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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