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What makes a good manager? If you are presently a manager you probably ask yourself this question frequently. If not and you are being considered for the pos

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

ition, take heed to some skills that are needed to be the best you can be.

Why would someone who is presently a manager think or worry about what it takes to

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

Examples of combination products may in

be a good manager? In all positions of life, whether work related or personal, we should want to put our best efforts forward for everyone to recognize. If y

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

ou are recognized as a good manager, you have skills several people in the business world do not possess. Good skills lead to good referrals for promotions or

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

opening doors for other positions of influence.

Not too long ago I had a Supervisor of a call center ask me for suggestions on how to improve in their positi

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

Combination pro

on. At the time I was the Director of a department of 17 Regional Area Representatives. Here are some of the suggestions I gave:

Listen<

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

/b>—Listen to everything your subordinates have to say. That does not mean you have to agree with them but have an ear for listening. I tried to keep an open

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

ear to listen to everyone whether what was heard was good or bad.
Share—Keep everyone updated on department and company developmen

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

ts. If asked to keep confidentiality, you can share the department goals and progress the department is making on a weekly and/or monthly basis in their achie

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

vements. Sharing is communicating. You must communicate with your people on a daily basis. I emailed frequently and communicated via telephone weekly. I ha

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

ve to say I believe they preferred the telephone over the email. Everyone loves the personal touch!
Engage—Let the group be involved i

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

Following aspects would a

n the decision-making process. When it comes to working with department decisions, engage the team and let them share their thoughts and ideas with you. I re

dd to the challenges in developing combination products:

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

commend conference calls if people are in distant locations so everyone is able to have an input. Again, that does not mean you have to agree but you are lis

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

tening to their suggestions. If you choose to overrule that is your decision as a manager.
Interact—As often as you feel necessary, sc

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

hedule a time away from the office for lunch, after-hours social, retreat, or training. It is important that the department feel you are as much a part of the

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

m as you are their supervisor. I had worked with people in the past who felt it was not good to intermingle with the people they managed. I believe it helps

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

Professional from academic institutions, pharmaceutical industries, health care indust

you to know the persons work ethic, personality, integrity, and also made me more accessible to them. I believe almost everyone I supervised would tell you I

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

treated them as an equal. I do not believe in the superiority complex.

I believe every person has something to offer. It is up to the manager/supe

.

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

rvisor to find and reveal the qualities. If after finding the qualities and they do not fit what is necessary for success in the position, the manager has to

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

Companies that provide selfless information through particip

do what is necessary to correct the mistake. Every good manager is willing to admit they make mistakes. The best manager is the one who corrects the mistakes

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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