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It’s coming up for that time of year when school’s out and everyone heads off for their summer holiday.

If you’re someone who relies on email as part of your business, yo

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

u probably dread coming back from holiday to hundreds of emails. The thought of spending the first week dealing with them all and feeling that you’re having to catch up a

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

Examples of combination products may in

ll the time, so here are a few ideas to help you deal with the backlog.

The process for dealing with a holiday backlog is the same as handling emails on a daily basis, th

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

e volume is just much larger.

Once you’ve planned out the important things you need to get done on your first day back, set aside an hour to go through your inbox. Yes,

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

know it’s probably going to take much longer than that but it’s just the start.

Don’t respond to any new incoming emails until you have cleared w

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

Combination pro

hat’s already in your Inbox.

First scan – DON’T READ OR RESPOND TO ANY EMAILS ON THIS SCAN. Just go through quickly and eliminate the spam and any email

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

you know you don’t need to read. Use the sort function to sort your email by sender or subject, which makes it easier to delete the junk.

You don’t have time to read ev

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

rything so delete anything that doesn’t require your attention or have information you absolutely MUST have. Don’t save it ‘just in case’.

Second scan –

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

pick out all the priority emails you need to respond to first and place them in a separate ‘Action’ folder.

Set aside time in your diary to respond to your ‘Actio

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

n’ emails – either do this in that first hour, as you should still have a reasonable chunk of the first hour left, or set aside more time later in the day.

Depending on t

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

e volume of emails, you should be able to complete these first two scans in the first hour. Do the third scan too if you still have time, otherwise leave that until the n

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

Following aspects would a

ext time you’re scheduled to work on your email.

Allow yourself a few minutes to take a quick look at any new emails – in case there is anything important that needs atte

dd to the challenges in developing combination products:

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

ntion, but I mean a ‘few minutes’. Don’t get distracted!

Third scan – if your filters haven’t already sorted out reading emails, now is the time to plac

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

e all of these in the appropriate folder(s).

Fourth scan – deal with what’s left. Less urgent action emails can now be dealt with. What’s left

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

If it’s not action or reading – it’s probably not urgent so can be deleted.

Once you’ve safely dealt with the backlog that came in while you were away – only then, can

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 deal with applying the same process to the new emails that have come in.

I’ve mentioned before that I have a number of accounts that I use to sort my email before it

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

Professional from academic institutions, pharmaceutical industries, health care indust

even gets to the Inbox and folders. Non-essential newsletters and recent Internet account sign-ups, go to one email address. Postings from discussion groups go to anothe

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

account. Work related emails and the newsletters I really want to read, go to my main account and then use filters to sort these into folders.

Before you go away

.

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

– if you have the option – switch any email groups to special notices or admin only. You can do this for all Yahoo groups and some online discussion/networking groups us

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

Companies that provide selfless information through particip

ually allow you to switch off email notification. This will reduce the volume coming through in the first place so you have less to deal with.

Copyright 2006: Clare Evan

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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