References - Self Improvement

If I had a dollar or even better a pound for every time I’d heard a business leader say this I’d be very rich.

I’m too busy is used in so many cont

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

exts

* I’m too busy – I don’t want to
* I’m too busy – I’m overwhelmed
* I’m too busy – Go Away
* I’m too busy – I’m confused
*

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

Examples of combination products may in

I’m too busy – And you’re not!

If we break that sentence down and look at each part, we can then look at ways of helping you be less busy.

I’M

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

too busy – with the emphasis on the I, the inference is that the centre of the busyness is you. The implication is that you need to be because

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 are the only person that can do all of the work that is causing you to feel busy.

I’m TOO busy – with the emphasis on the TOO, the infere

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

Combination pro

nce is that your busyness level is more than you can cope with. It implies that you have to cope with more work than is comfortable for you.

I’m 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

o BUSY – with the emphasis on the BUSY, the inference is that you have lots to do but that it might not be useful or productive work or work

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

hat you feel you should be doing.

So let’s assume that’s the case and the work you currently have that is causing you to be too busy, is largely ma

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

de up of work you feel you shouldn’t be doing, i.e. it is work that is not specifically contributing to your goals and targets.

So what’s the answe

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

r?

Here is a process for you to try to Get Creative, Get Focused and Get Control

1. List all of the tasks, activities or pieces of work you curren

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

ly have “to do”

2. Give each task a priority 1-5 (1 being high 5 being low) based on their relevance to your specific goals or targets

3. Give eac

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

Following aspects would a

h ask a MUST, SHOULD COULD rating

a. Must – you are accountable and responsible for its completion
b. Should – You are accountable but not nec

dd to the challenges in developing combination products:

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

essarily responsible i.e. you must make it happen but someone else could do it
c. Could – You are neither accountable or responsible

4. For ea

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

ch must

a. set a deadline for completion and schedule it in you diary/PDA now

5. For each should

a. make a list of who else could do it and why i

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

might be more appropriate for them to do it
b. prioritise this list

6. For each could

a. decide to do it and schedule it
b. delegate it

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

and schedule time to hand the work over
c. discard it completely

“The key is not to prioritise what’s on your schedule, but to schedule yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ur priorities” Stephen R. Covey

Just because you assume you’re too busy doesn’t mean that you are.

You have a choice not to do something and y

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

u can choose to make different decisions about what work you do and what work you don’t. If you work for someone else help them to help you by havin

.

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

g regular discussions about you workload and what work is a Must, Should and Could for you – don’t just accept everything that comes your way.

Take

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

Companies that provide selfless information through particip

control and get creative about how you think about and how you manage your workload. Your level of busyness is down to you.

©2005 Beverley Hamilto

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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Can you imagine if you had someone following you about all day criticizing every single thing that you did? It would literally drive you crazy! Yet this is what we do to ourselves and more often than not we don’t even know we are doing it.

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