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From April to October each year, communities open the doors to some of their most intriguing and charming heritage sites. Admission to those events is free. And everyone is invited to ex

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

perience these hidden heritage treasures first-hand. Communities boast of their commercial buildings, courthouses, places of worship, gardens, and natural heritage sites.

In early sprin

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

Examples of combination products may in

2006 we were asked to participate in the Doors Open Event in our County.

Doors Open started in France in 1984 and soon spread to neighboring countries, including the Netherlands, Swede

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

n, the Republic of Ireland, Belgium and Scotland. In 1991, these events were united as European Heritage Days

In 2000, the City of Toronto started the first Doors Open event in North Am

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

rica and in 2002, the Ontario Heritage Trust launched the province wide Doors Open Ontario. It is now held across North America with events now being held in Newfoundland, Alberta, Massa

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

Combination pro

husetts, Western New York State, New York City and Denver.

We own a modern Equestrian facility, home to a breeding farm of Warmblood horses and a riding school. We’ve organized many tou

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

rs over the years and we were quite willing to participate. We were asked to send a good photo of our facility and this photo, along with a short description of our site, was published i

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

the official Doors Open magazine. This magazine is available at all tourists’ information booths.

Several information sessions were held where we were given information about what to d

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

. We were given Doors Open T shirts for our volunteers, tracking sheets, survey sheets, and many flyers.

Having about 40 horses, mares, stallions, young stock and schooling horses, we h

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

ad some very busy days before hand.

The riding school students had been practicing a musical show, called a quadrille, where they preformed to music on horseback. It is always a very ni

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

e opportunity for the students to show off to the public what they can do. The day before the Event they all came to wash their horses, braid them and fancy them up. White ponies all of

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

Following aspects would a

sudden had a pink tail and main thanks to Cool Aid juice.

Riders and horses were color coordinated, with orange or yellow ribbons and beads in their mane, and the same color polos and

dd to the challenges in developing combination products:

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

saddle pads.

On the days of the event people started coming in at 10 am and a steady stream of visitors came in till we took the signs away on the road at 5 pm. We had a program for our

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

days, and although we did send it to the organizing committee and the radio, most people did not know about the program, missing out on some of the parts they would have liked to see.

B

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

sides the musical performance by the students on horse back, we also had one of our stallions jump on an artificial mare while we collected his semen. We then had the people look at the

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

semen under the microscope so that they could see how that looked. This was definitely one of the most popular events as not many people get a chance to see it.

We closed the day off wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

h a demonstration free-jumping, a training aid for young horses. Free-jumping is when horses jump over a series of jumps without a rider on their back. This is so we can judge their natu

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

al ability as jumpers.

We also took the people around through the barns explaining the equipment we have, like a computerized exercise machine and other features of the facility.

The p

.

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

urpose of a Doors Open Event is so that people can discover what heritage is in their area and see facilities they normally would not have a chance to see.

Several hundreds of people pa

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

Companies that provide selfless information through particip

sed through our facility those two days and many commented on how wonderful the Doors Open program is. If there is a Doors Open Event in your area, attend it, it is definitely worthwhile

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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A loved-up Gerry McDonnell shares his thoughts on the weekend FA Cup action. As always, the easily offended should steer clear.

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