Advice Pool - Business

Where Do Interruptions Come From?

The Boss

• Who often has the power when it comes to setting priorities

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

Subordinates

• The more accessible you are, the more they’ll use/abuse you

Fellow workers

• Interrupt for 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

reasons from social to work-related

Clients and customers

• These you can’t ignore

Phone

• Sounds familiar?

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

Dealing With Interruptions:

When you’re interrupted, ask yourself what’s more important: the interruption or what y

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

ou’re working on? You can keep a ‘To Do’ list to re-focus on what you should be doing after the interruption has gone away.

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

Combination pro

What you can do, is try to keep interruptions short – ‘What do you want, why, when, etc?’ You can also keep a log of who/what

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

interrupts you.

You should also consider the following:

• Be assertive; learn to deal with ‘Have you got a minute?’

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

• Invent deadlines

• Continue to look busy

• Stand up to interruptions

• Remove the chair in front of your desk

• Reduc

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

e eye contact

• Collect your papers, check your watch

• Go to them – this way you can leave any time

• Learn to say ‘no’

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

• Plan a quiet hour

And Finally – Beware Of Monkeys:

Despite being a busy person, it is easy to get sucked into doin

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

g things for others. Often these tasks have nothing to do with your job (perhaps they interest you or you are flattered to be

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

Following aspects would a

asked!).

Each time we say ‘yes’ to these requests we collect another ‘monkey’, namely a problem that started with someone e

dd to the challenges in developing combination products:

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

lse (who is working for whom?).

Furthermore, ‘monkeys’ eat into our discretionary time; the amount of time left after meetin

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

g the demands of boss and job.

‘Taking the monkey’ often means that you are taking on a problem. Also, you are preventing ot

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

hers from taking the initiative and dealing with it themselves.

So, to handle monkeys:

• Deal with them as they hap

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

pen (say ‘yes’, you can help or ‘no’, you cannot).

• Do not allow them to become too many to handle.

• Feed them face-to-

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

Professional from academic institutions, pharmaceutical industries, health care indust

face only or by phone (avoid memos or email).

• Feed them by appointment only; ‘Come and see me at …’

• Assign a next fee

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

ding time; ‘Try, and if you get a problem come back and see me’.

TIP: Never say ‘Leave it with me’.

You may f

.

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

ind this additional reading helpful: elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

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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