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As a leader, you'll inevitably be faced with people wanting to leave your team or organization. Dealing with the challenge is critical for your leadership success. Your response will have ramificatio

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

ns far beyond your immediate circumstances. One of the best ways to respond comes from Shakespeare's Henry V.

The stirring speech of Shakespeare's Henry before the battle of Agincourt contains many

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

Examples of combination products may in

leadership nuggets. But commentators who recount the speech usually overlook a particularly valuable one. They focus on the speech's "band of brothers" aspects but neglect the fact that Henry also sai

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

d that if any of his soldiers would rather not fight, he'd give them passport and "crowns for convoy" back to England.

Henry was aware that some of his soldiers were reluctant to fight; for he led a

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

rather bedraggled army. History recounts they had marched 260 miles in 17 days. They were short of food. They were drenched by two weeks of continuous rain. Many of them were suffering from dysente

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

Combination pro

ry contracted from drinking fetid pond water. And they were facing the flower of French knighthood, knights who were rested, better equipped and eager for battle. So there were probably many soldiers

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

who wanted to avoid battle, get quickly to the coast and board ships for England.

Shakespeare has his Henry respond to these leadership challenges in a telling way. Instead of trying to cajole thos

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

e who wanted to leave into remaining with him, or on the other hand, punish them, he did something much more effective: He actually offered them passports and money to go.

"Rather proclaim it, Westmo

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

reland, through my host, That he which hath no stomach to this fight, Let him depart; his passport shall be made, And crowns for convoy put into his purse; We would not die in that man's company

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

That fears his fellowship to die with us."

Now, apply this lesson to those people who tell you they want out. You may find yourself reshaping your relationship with them in positive ways and boos

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

ting your leadership effectiveness with the people who remain.

Here's how you do it. Offer them "crowns for convoy." Have them draw up specific leadership actions that they will take to leave. Prov

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

Following aspects would a

ide milestones and ways that you and they can monitor their progress. Support them in their taking leave as you would any cause leader who is staying.

One might say that if somebody wants out ... goo

dd to the challenges in developing combination products:

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

d riddance! But let's examine this. When somebody wants to leave, two facts apply. One is that, clearly, that person - for whatever reason - is dissatisfied and is looking for satisfaction elsewhere.

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

And two is that you have a relationship with the person. It might be a good relationship. It might be a bad relationship. But here's the point: You don't want to get the two facts mixed up in a bad wa

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

y. Because that relationship will continue in one way or another even if you don't set eyes on each other again.

A bad relationship with an employee that left your organization can come back to haunt

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

you in many unforeseen ways. For instance, it may poison your relationship with the people who remain behind. By supporting that person in taking leadership of their leaving, you are creating an opp

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

Professional from academic institutions, pharmaceutical industries, health care indust

ortunity for you to change your relationship with them, to work together in a positive way. This may help redress any bad feelings that might have otherwise grown worse.

When CROWNS FOR CONVOY are n

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

ot offered in spite or rancor but out of a genuine desire to help, you'll transform a potentially bad situation into a beneficial one. And who knows? Maybe, like Henry, you'll achieve an unexpected up

.

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

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

Companies that provide selfless information through particip

d to the author, and it appears with the included copyright, resource box and live web site link. Email notice of intent to publish is appreciated but not required: mail to: brent@actionleadership.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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With holiday shoppers out and about in record numbers this season, many restaurants and retail establishments are thriving. Unfortunately this also is an ideal time for robbers to prey on unprepared businesses. We've put together a special reminder for business owners in hopes of lessening the chance that harm comes to your hard working employees and management teams.

If you sell goods or services by telephone, fax, or the internet, then the timing of your delivery MUST comply with federal law.

Without a doubt one of the most crucial tools available to supply chain professionals today is information technology (IT). IT can be the glue that help Supply Chain deliver real value to organizations – however an incorrectly configured system or a poor technology choice can bring its own problems – here we check out 6 things that your Supply chain IT system should deliver.

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