Advice You - Business

It used to be that we poor, run-ragged employees could routinely expect ongoing intimidation from our bosses for a long litany of reasons, quaking in our boots those

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

bleak mornings when we had to call in sick (even when legitimate!), quivering at the knees while pleading for a much-deserved, long-overdue raise, wishing for simpl

; 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 praise for a job well done but winding up instead with “constructive” feedback. Even taking time off for a joyous trip to the dentist or (God forbid!) picking our

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

children up at school might provoke visions of the gods raining hellfire down upon us the very moment we dared to asked for permission.

So my, my, my, how times hav

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

changed! Now it’s employers and bosses who wrestle with such delicate issues of communication. Today it’s they who carefully phrase their wishes and requests to emp

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

Combination pro

loyees, lest the best and brightest (even the so-so!) get upset, belch brimstone, storm out the door. Certainly if it’s you who are today waging this very battle you

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

rself, I realize you would love it if I could offer you some kind of answer to help you out. And I am, but am also certain my advice will be somewhat unexpected: try

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

a little understanding and acceptance!

Look around at the entire business community for a moment with a wider-focus lens than usual to help you look. Here’s a truth

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

: What goes around, comes around. Karma is currently in full swing. Sweet revenge is in the air. Justice prevails, the dogs are having their day, chickens (legions o

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

f them) have come home to roost. Choose your favorite clich? but please get this: Too many decades and centuries have now passed in which employers have enjoyed boun

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

iful opportunities to mishandle their workers. Entire firms have treated their people like expendable chattel, roughing them up verbally, occasionally even physicall

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

Following aspects would a

y, chewing and spitting them out, tossing them away. Layoffs, downsizing, terminations, “rightsizing”—you name it! But this game has now shifted dramatically.

It’s

dd to the challenges in developing combination products:

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

become increasingly common, for example, for employees to, just all of a sudden, call it quits. They might bolt away to start new venture, or a family, or adopt a n

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

ew career or new employer. This of course leaves YOU, their immediate manager, swinging in the breeze. You may have just spent six months-- nay six years! -- groomin

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

a staffer, perhaps for some pivotal strategic play in a top-seeded project, or maybe for a smart, upper-level executive slot. Then poof! She or he is gone.

And if

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 ask them to stay a week or two longer, to help ease the transition of someone new, you may be faced then with demands for bonus incentives to stay for a few mor

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

Professional from academic institutions, pharmaceutical industries, health care indust

e days, or with a proposal-plus-invoice for a lucrative consulting fee. And should they be leaving on any negative terms at all, better run for the hills: Your HR ma

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

ager’s ears will burn, baby, burn at that exit of all exit interviews… as will yours.

The only potential advice here may be to grin and bare it, praying for some ka

.

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

rmic reckoning that runs it course as things eventually level out the playing field. Acceptance is the first step to riding the situation out! The workers are in cha

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

Companies that provide selfless information through particip

rge of the asylum now although its basic dynamics haven’t changed. After so many abrupt, merciless, mass terminations in the 80’s and 90’s, what else might we expect

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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/23519/adviceyou-The-End-of-the-TwoWeek-Notice.html">The End of the Two-Week Notice</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/23519/adviceyou-The-End-of-the-TwoWeek-Notice.html]The End of the Two-Week Notice[/url]

Need to know what the latest trends is business are? We have the answers you've been looking for!

A question I hear or read often is, ‘is that professional enough?’ What is ‘professional’, and how is one professional and what is considered unprofessional?

If you think, 'it's just an interview for a temp job -- no big deal,' that's where you're mistaken. Some wonderful opportunities, networking connections and careers have resulted from temporary posit...

Tags

Links

Advice You - The End of the Two-Week Notice

Related Articles: