References - Travel and Leisure

Two very different events, one originating in India and the other in Europe - and both of which could be described as ‘celebrations of light’ - are now held in Britain every year between mid-October

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

and mid-December. The occurrence of these events is one indication of the multi-cultural nature of modern British life. One is Diwali, the Hindu festival, and the other is the traditional Swedish ‘

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

Examples of combination products may in

ucia Day’.

Diwali - the Festival of Lights - is the most popular Hindu religious festival, and marks the Hindu New Year. Because Diwali is a date in the Hindu calendar, which is based on the lunar

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

cycle, the date in the western calendar varies from year to year between mid-October and mid-November.

Lucia, in contrast, is a Swedish event of medieval origin that takes place every year on Decem

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

er 13th and recognises the need for goodness and light to overcome the darkness during the longest nights of the year. Using the modern calendar, the longest night is that of 20th/21st December, but

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

Combination pro

Lucia dates from the time of the older Julian calendar. December 13th is also the feast day of the 4th century Sicilian Saint Lucia who, I guess, has about as much real connection with Sweden as St

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

George does with England. The story – as I heard it – goes that Lucia was a pious Christian woman who was loved by a nobleman. She didn’t care for him and wished to go on with her religious life, so

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

she refused to marry him. His response was to have her killed, and so she became a martyr.

In the traditional Swedish ‘festival of light’, Lucia is a girl or young woman, wearing a white robe with

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

a red ribbon round her waist and, on her head, a Lucia crown made up of candles. Once upon a time they used real candles, but too many girls set their hair on fire, so now battery-powered candle-sha

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 lamps are usually used instead. In the procession, Lucia is attended by several more girls, also dressed in white and carrying candles. Boys, known as 'star boys', also participate: they, too, ar

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

similarly dressed in white and wear pointed caps. Lucia and her attendants visit public places like hospitals and old peoples’ homes and sing traditional songs such as Sankta Lucia, which you can

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

Following aspects would a

listen to in Swedish by visiting the website http://www.luciamorning.com/music.html and clicking on ‘Play’. They also usually hand out coffee, gingerbread biscuits and 'lussekatter', a special form

dd to the challenges in developing combination products:

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

of saffron-flavoured bun. In most factories and offices, some of the company’s staff carry out this ceremony and most employees attend. It takes place at about 7 o’clock in the morning, before wor

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

k; however, where I worked at least, mulled wine was always served along with the coffee (you needed both at that time on a dark, cold December morning), and productivity was definitely low for the

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

est of that day. In most Swedish homes, the children love to perform the ceremony for their parents, with the role of Lucia traditionally going to the oldest daughter. In the absence of children of

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

uitable age, some wives act as Lucia for their husbands.

To find out more about Lucia in Sweden, you can Google “lucia+sweden’, which will offer a wide choice of sites, including official governmen

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

Professional from academic institutions, pharmaceutical industries, health care indust

t and tourist information sites. Lucia is also celebrated by Swedish communities all around the world, and in England I know for sure that processions will take place at the Swedish Church, Embas

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

y and School and in the homes of many Swedish families who live here. People may be more surprised, however, to learn that in recent years Lucia has also been celebrated on a larger scale in a major

.

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

London cathedral: in 2002, the event was held in Southwark Cathedral, and then in St Paul’s Cathedral. This year it will switch to Westminster Cathedral (not the Abbey) on December 15th. My daughte

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

Companies that provide selfless information through particip

(who lived in Sweden between the ages of 3 and 19 and has taken part in Lucia processions) attends every year: the event is highly popular and tickets are required; the money raised goes to charity

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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