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I've lived in Aghios Nikolaos, Crete for the last 30 years. From the very first days I

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

was amazed at the feeling of belonging I felt, the hospitality shown to me and my fam

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

Examples of combination products may in

ily and above all the patience shown, by my Greek speaking neighbours, at my bad attem

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

pts to converse in their language. That was 30 years ago and through the years I've b

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

een waiting for an adverse reaction toward the increasing number of foreigners coming

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

Combination pro

here to live, but it hasn't happened.

I have finally put this phenomena down to the f

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

act that locals feel sorry for us, far from home and family. In Crete, to have a crow

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

of relatives is a kind of security - the more the stronger and to be away from your h

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

ome country must be a painful experience.

Greek friends of mine have actually express

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

ed relief that I can - if I want - meet with people from my own country and speak my o

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

wn language.

In 1998 a multinational association was started here in Aghios Nikolaos.

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

Following aspects would a

This association is called INCO and under the umbrella of INCO a few groups have star

dd to the challenges in developing combination products:

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

ted up.

Our mulinational theatre group performs a show every year (not unlike the Bri

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

tish pantomine) for all the family, in Greek and in English.

Our multinational choir

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

amed 'The Rainbow Choir' is becoming quite famous.

We have a gardening group that mee

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

t every month.

Last but not least is our natural history group that are, as I write,

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

Professional from academic institutions, pharmaceutical industries, health care indust

driving in a convoy up the side of a mountain to catch a glimpse of bearded vultures.

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

All our groups are totally encouraged, not only by our local friends but also the tow

.

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

n council of Aghios Nikolaos.

So if you decide to come to Aghios Nikolaos to live, yo

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

Companies that provide selfless information through particip

u can realise your Cretan dream life and join or create a new interest group with INCO

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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