Wouldn’t it be nice if you could just take a simple test to resolve your conflicts and have proper conflict resolution? A multiple choic

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

e test would be the best:

1. The person you are in conflict with is?

a. Controlling

b. Indecisive

c. Demeaning

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

Examples of combination products may in

e>

Just choose letter A, B or C and you magically uncover the solutions to all your conflict problems.

How great and easy would that b

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

!

Unfortunately, conflict is much too complicated to squeeze into a simple multiple choice test. Conflict is a complex experience invol

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

ing feelings, thoughts and behaviors of all people involved.

No two people are exactly alike; therefore no two confli

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

Combination pro

cts are exactly alike. Every conflict requires its own unique resolution that could never be figured out by answering a series of multip

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

e choice questions.

Remember, every conflict is unique. Each requires its own solution in order to arrive at a reas

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

nable and fair resolution.

Knowledge is power!

By first understanding what your conflict looks like, you will begin creating fa

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

r and useful resolutions that everyone will be satisfied with.

Here is a list of questions to ask when you are in the midst of conflict

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

...

ESSENTIAL CONFLICT RELATED QUESTIONS:

• Is the conflict specific to a situation? (i.e. due to a specific event or p

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

rson(s))

Does the conflict arise from a specific task or goal you are trying to accomplish?

Is the conflict related

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

Following aspects would a

o defining what a goal should be?

Is the conflict due to differences in how a process should be carried out?

Is the

dd to the challenges in developing combination products:

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

onflict something people discuss freely or is it covert and “taboo?”

Does the conflict exist within a group or team, or among

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

a few?

What has prompted you to seek conflict resolution now instead of earlier or later?

On a zero to ten scale (0=

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

not a problem, 10=unbearable), how would you rate the level of conflict six months ago versus currently?

You may be able to

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

answer these questions, but how do you begin to take the next step toward conflict resolution? Building on these questions often require

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

Professional from academic institutions, pharmaceutical industries, health care indust

the assistance of a conflict resolution professional. A professional serves as an objective observer who understands how to identify an

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

d find resolution to even the most complex conflicts.

Proper resolution to conflict will equal unparalleled benefits:

• Create

.

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

more profitable work teams

Improved communication, creativity and motivation

Inspire improved performance from emplo

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

Companies that provide selfless information through particip

ees

Strengthen employee loyalty and commitment

Improved organizational decision making and follow through

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products