Advice You - Business

If you are a pro-active, get-things-done type, sooner or later you will come in conflict with your boss. The same sort of assertiveness and confidence that leads you to have a mind of your own has helpe

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

d him to earn his position.

Another reality is that if you do not have some periodic disagreements with your supervisors you are probably not being as assertive as you should be in moving your career

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

Examples of combination products may in

ahead.

These conflicts can prove to be hazardous to the health of your career if they are not handled with common sense, says Ramon Greenwood, senior career counselor, www.CommonSenseAtWork.com>

No o

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

ne enjoys conflict, especially with the boss. But when you have an honest difference of opinion, it is better to pay the price of discomfort and take the risk of some penalty than to bottle up the frus

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

ration and nagging conscience that results from not meeting what you see as your responsibilities.

Knowing you will have conflicts, you can be prepared to handle them so there are no individual loser

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

Combination pro

s.

TURN CONFLICTS TO ADVANTAGES

Greenwood says there are nine steps you can take to lessen the damage that can result from conflicts with your boss. In fact, you can turn these conflicts to your advan

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

tage.

1. The first step is to concisely define the issue-- preferably in writing-- so that you have a clear understanding as to what the controversy is all about. Determine how important it is to the

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

parties involved and to the organization.

If it is not truly important beyond your personal feelings, forget it. Save your energies for another time when the stakes are significant.

2. Give full con

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

ideration to the points of view of all parties concerned, especially the boss. His responsibilities are different than yours. He may have a legitimate reason for his opinion, which you are not aware

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

of at the moment. The conflict you see may disappear with an explanation.

3. Weigh your reasons and objectives against the good of the organization. Before you “go to the mat” on an issue, be sure y

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

ou are motivated by what you believe to be the larger interest and not just your own narrowly defined agenda.

4. Ask for a face-to-face discussion with your boss if, after due consideration, you stil

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

Following aspects would a

l feel the difference is worth pursuing. If the matter is not resolved with a meeting, ask permission to leave a written explanation with your boss for his further consideration.

5. Never push your b

dd to the challenges in developing combination products:

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

ss into a corner where he has no room for compromise. Do not air the conflict with your boss in the presence of others.

6. Avoid letting the matter be positioned on a personal basis. Emotions and

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

personalities have no place in a confrontation with the boss.

7. Be tactful. Show respect for the boss’s position and responsibilities. Whatever the outcome of your differences with him, he is still y

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

our boss.

8. Keep the matter in perspective. It is good to remember that win, lose or draw, it is a rare situation when the resolution of an issue results in a pot of gold at the end of the rainbow o

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

r the world coming to an end.

9. Don’t pin a medal on your chest if you prevail or wear the black of mourning if the decision goes the other way. Get on with the job. If you have been heard and the bo

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

Professional from academic institutions, pharmaceutical industries, health care indust

s still doesn’t agree, be a good trooper, support his decision, openly and aggressively. If the outlook is contrary to your basic values look for another job.

If you can’t discuss the inevitable confli

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

cts with your boss in a free and open manner so as to arrive at acceptable resolutions, or if such disagreements are so frequent and painful that your life and career are being disrupted, recognize yo

.

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

u have a problem larger than any single issue. It may be that you are at odds with the standards and objectives of the boss or the organization. Or the personal chemistry between you and your boss m

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

Companies that provide selfless information through particip

ay be out of balance.

If you can’t resolve the conflicts or live with them, locate another opportunity. Life is too short to exist in a world of turmoil and confrontations, in the opinion of Greenwood

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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