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The busiest maternity hospital in the world is my client. They were once listed

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

in the Guinness Book of Records for ‘most babies delivered in one year’!

Pregna

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

Examples of combination products may in

nt women appreciate the slow pace of elevator doors at the hospital, but visitor

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

s and guests complain, ‘The elevators close too slowly!’

The slow doors are int

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

entionally programmed to give pregnant women and wheelchair-bound patients more

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

Combination pro

time to enter and exit. If the hospital were to speed up the program, you can im

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

agine the complaints: ‘The elevator doors close too fast!’

What would you do in

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

this situation? Go faster? Stay slow? Endure the ongoing complaints? This hospi

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

tal tried a more creative and cooperative approach.

Attractive signs were poste

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

d in the lobby and inside each elevator car saying: ‘Thank you for assisting pat

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

ents who may require extra time to reach the elevator. Your kindness is apprecia

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

Following aspects would a

ted.’

Suddenly, slow elevator doors become a gesture of care and concern for ot

dd to the challenges in developing combination products:

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

hers, while visitors ‘in a hurry’ are just as quickly included in a gracious soc

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

ial effort.

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

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Sometimes the facts of th

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

e matter don't need changing at all - only the way we look at them needs to shif

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

Professional from academic institutions, pharmaceutical industries, health care indust

t.

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

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If something is bothering you or your s

.

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

taff, your visitors, guests or customers, see if you can shift the language and

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

Companies that provide selfless information through particip

change the point of view. It's one powerful, effective way to change a situation

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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The basic ISO 9000 procedures include document control procedure, records procedure, internal audit procedure, control of non-conformance procedure, corrective action procedure, and preventive action procedure. Documentation is a basis upon which an ISO-compliant quality system is constructed. An unauthorized change in any information makes problems. Your mandatory document control procedure must define how you approve documents, update and re-approve amended documents, prevent the inadvertent use of obsolete documents, and ensure that documents are available where they are needed.

Of the four business meetings I have held so far this week; only in one case was the other person able to produce an up to date and informative business card, despite the fact that they were all very senior executives. As I have said on numerous occasions, a common (and often overlooked) image feature for every would-be business professional, is the business or calling card (the summary information about yourself you choose to give to others).

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E-Folder - The Power of a Pregnant Pause

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