Main Subject - Business

Are you overwhelmed by piles of paper? Does it seem impossible to catch up? Well, it does require some effort on your part an

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

d some paper management skills, but it can be done. Paper causes anxiety because it is often a reminder of all of the things w

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

Examples of combination products may in

have to do. An effective paper management system can help move those piles of paper from ‘to-do’ to ‘done!’

First, designate

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

an in-box for all incoming paper and process it frequently. Designate containers for each of the following paper decisions: D

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

it now, Do it later, Delegate it, Toss it, or File it.

Do it now- Actually, I recommend processing all of the paper in your i

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

Combination pro

n-box prior to acting on it, at least initially. If not, you may decide to keep acting on each paper and never get around to c

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

mpletely processing your in-box.

Do it later- Determine what the actual next step is and then schedule a time and day to do it

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

. Your initial determination might be that you have to respond to an invitation- but later you realize that you have to check

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

ith your co-worker or significant other prior to responding. Most importantly, later never comes. It is essential to block ou

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

t time in your day to actually do it.

Delegate it- Many times it is more productive to delegate some tasks than to try to do t

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

em ourselves, even when we have to pay an expert for their time. It may take you two or three times as long to accomplish the

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

Following aspects would a

same task and often cost the same or less. Experts have the tools and skills to get it done efficiently and effectively.

Toss

dd to the challenges in developing combination products:

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

it- Insert ‘recycle’ or ‘shred’ here. Anything with your name and identifying information on it should be shredded and most ot

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

her papers can be recycled. If you have a ‘to shred’ pile that never gets shredded, perhaps it’s time to invest in a better sh

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

edder or delegate this task.

File it- I have found the most effective method for filing papers is by their shelf life. A ‘to-

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

do’ may only have a shelf life of one week, whereas insurance policies usually have a shelf life of one year, while tax papers

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

Professional from academic institutions, pharmaceutical industries, health care indust

an have a shelf life of ten years. So divide your filing into sections for active, reference, and archive. Active papers shou

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

ld be stored in your ‘prime real estate’ on your desktop. Reference documents can be located in desk filing cabinets or close

.

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

y. And finally, archive papers should be stored in another location.

Designating an in-box and understanding the decisions to

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

Companies that provide selfless information through particip

be made when processing paper is just the beginning of tackling your paper clutter...but it is your first step towards success

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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