Business Dump - Travel and Leisure

Known locally as “Sanfermines”, this raucous festival takes place in the Basque town of Pamplona between July 6th-14th in honour of the city’s patron saint, San Fermin. It is the most popular and most famou

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

s of all Spanish fiestas and is known throughout the world and visited each year by thousands of foreign tourists. This fame is down to the infamous “Encierro” or the “Running of the Bulls”, a dangerous tra

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

Examples of combination products may in

ition where thousands of locals line the streets of Pamplona’s old town and run the gauntlet will six half ton bulls over an 800 metre stretch. There is much more to the festival than just the “Encierro” an

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

they include a lot of other ancient traditions as well as a fair dose of drinking and partying.

The origins of the festival are somewhat convoluted; it seems that over the centuries several traditions and

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

festivals have amalgamated into one week-long fiesta. The festival of San Fermin was originally held in September but was transferred to July in 1591 due to the unpredictable nature of the autumn weather.

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

Combination pro

ull running seems to date back to the 14th century and there is a tradition of it all over Spain where numerous towns and villages practice the ritual in their festivals.

The festival all starts with the “

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

hupizano”; the firing of a rocket which indicates that the festival has officially begun. Thousands of locals gather in the central square in front of the town hall and the uproar as the rocket is fired can

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

be deafening. Thousands of Cava corks are popped and bottles are sprayed around with much cheer. The packed square then don their famous red neckerchiefs and tie their red sashes around their waists. A wee

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

of fully-fledged partying is only just beginning.

The “Encierro” is clearly the most famous facet to the festival and is probably the thing that has caused such a huge influx of foreign visitors to the ci

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

y in recent years wishing to take part in (or at least witness) the famous spectacle. The course is just a shade over 800 metres and takes the bulls to the bullring for the afternoon “corrida” (bullfight).

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

ix bulls are released every morning of the fiesta between the 7th and the 14th at 8am. The human runners pack the course, buzzing from nervous energy and adrenalin and attired in white with their traditiona

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

Following aspects would a

l red adornments. A rocket is fired to indicate that the bulls have been released and three minutes of white-knuckle madness begins as runners try to pick a suitable point to exit the course without putting

dd to the challenges in developing combination products:

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

themselves in harms way.

There’s no doubting the extremely dangerous nature of the “Encierro”; between 1924 and 1997 there have been fourteen deaths and over 200 serious injuries with the last fatality occ

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

rring in 1995 when a young American tourist was fatally gored. The “Encierro” is serious business and a rite of passage for the young Spaniards, many claim that the influx of tourists (who’s experience of b

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

ulls, let alone running with them, is non-existent) is making the “Encierro” even more dangerous.

The focal point of much of the festival is the afternoon “Corridas” which take place at Pamplona’s bullring

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

Due to the late night partying many locals don’t resurface until the afternoon to begin the next round of festivities. Other highlights of the festival include the “Comparsa de Gigantes” (the company of Gi

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

Professional from academic institutions, pharmaceutical industries, health care indust

nts), a parade where enormous puppets file through the town accompanied by brass bands and Guiri Day (Guiri is the Basque word for foreigners) where the festival pays homage to the overseas visitors who hel

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

p make the festival what it is. The city of 200,000 is said to swell to 2 million for the duration of the festival. Visitors can expect lots of street parties advancing into the early hours and vast amounts

.

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

of alcohol to be flowing. It is in general a very good natured festival and trouble and aggression are rarely met.

It all comes to a dramatic and emotional close at midnight on July 14th with a massive cro

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

Companies that provide selfless information through particip

d singing the mournful dirge “Pobre di Mi” (Poor Me) – it’s a magical, candle-lit end to a week of bacchanalian revelry and, once experience, we can see why it attracts foreign visitors in such vast numbers

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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