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When problems arise in your organization they need to be dealt with immediately and with a collectively develope

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 problem solving process. Those affected by both the problem and its solution need to be a part of the team th

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

Examples of combination products may in

at goes through the process and develops solutions to resolve the underlying issues that cause it. The followin

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

g are ten components of any such problem solving process that, if observed, will lead to effective and lasting s

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

olutions to the problems you face.

1. Team members readily contribute from their experience and listen to the c

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

Combination pro

ontributions of others.

2. Disagreements arising from different points of view are considered helpful; they are

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

seen as the crucible out of which unambiguous and honest solutions can flow.

3. Team members challenge suggest

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

ons they believe are unsupported by facts or logic but avoid arguing just to have their way or to be noticed for

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

their own individual input.

4. Poor solutions are not supported just for the sake of harmony or agreement.

5.

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

Differences of opinion are discussed and resolved. Coin tossing, averaging, straw-drawing, majority vote and s

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

imilar cop-outs are avoided when making a decision.

6. Every team member strives to make the problem solving pr

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

Following aspects would a

ocess efficient and is careful to facilitate rather than hinder discussion; each member strives to encourage and

dd to the challenges in developing combination products:

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

applaud individual efforts to contribute as well as the contributions themselves.

7. Team members encourage an

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

d support co-workers who are reluctant to offer ideas or to offer differing views from those already expressed.

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

8. Team members understand the value of time and work to eliminate extraneous and/or repetitious discussion.

9.

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

Team decisions are not arbitrarily overruled by the leader simply because he/she doesn’t agree with them; each

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

Professional from academic institutions, pharmaceutical industries, health care indust

member is committed to respecting each other’s views and to honoring the sources of these views as being legitim

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

ate and sincere.

10. The team understands that the leader will make the best decision he or she can if a satisf

.

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

actory team solution is not forthcoming; they each agree to support and promote the decision that results from t

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

Companies that provide selfless information through particip

he problem solving process whether it is made collectively by the team or individually by the leader of the team

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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As the labor shortage looms in the United States, this article describes 4 simple ways that companies can utilize their employee benefits to attract and retain great employees.

Business leaders are always looking for different ways to lead their organizations. With the possibility of shifting gears toward unconventional wisdom, some business leaders have turned their organizations into leading company's that are trend setters. These seven tips may be something you are looking for to give you company a new kick-start to move you forward.

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