Advice You - Business

Working with a verbally abusive boss is something that people often have to deal with.

I'

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

m speaking specifically about a verbally abusive boss and not one who is physically abusiv

; 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. If I had to deal with a physically abusive boss, I wouldn't be working there anymore an

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 I'd be consulting a lawyer.

If your boss uses abusive language, the first thing I'd try

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

to determine is whether they use it against just you or against others in the office. In o

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

Combination pro

ther words, is it a problem that only you face or have you witnessed your boss doing it to

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

others as well? Determining this might help you to see if you're in this alone or if ther

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

are others experiencing the same treatment.

If others in your office experience this beh

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

avior, do they also consider it to be abusive? In other words, might it be open to interpr

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

etation or is it definitely "abusive" in the eyes of any reasonable person?

Your first st

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

p could be to politely ask your boss in private to refrain from using the specific languag

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

Following aspects would a

e that is offending you. Be prepared to give your boss specifics if they ask since they mi

dd to the challenges in developing combination products:

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

ght not even be aware of it especially if they put any of it into writing ie. in their ema

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

ils to you.

If this doesn't help and if you have an HR department you might consider spea

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

ing with them although you do run the risk of making it look like you went over your boss'

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

s head which probably won't help. If you have a union or other professional representation

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

Professional from academic institutions, pharmaceutical industries, health care indust

, you should also consider consulting with them too of course.

You might consider printin

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

and retaining a hard copy of any emails or other written proof that document any verbal a

.

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

buse, too. It may come in handy down the line should you require proof.

In the first inst

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

Companies that provide selfless information through particip

ance, remain professional and calm if you choose to speak directly with your boss about it

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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