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The UK has some of the most stringent Health & Safety standards in the World. Most blue chip companies go even further than the prescribed standards to ensure the wellbeing of their employees. Yet the majorit

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

y of companies employ team building providers without checking on their own policies and procedures. In effect they are handing over the wellbeing of their employees to companies who do not have the same stan

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

Examples of combination products may in

dards as they do and in some cases companies who have no standards at all.

This is not to say that these companies are purposefully dangerous but some team building providers are small or one man bands and l

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

ack the resources to have set up and run an acceptable Health & Safety policy on an ongoing basis. In my experience less than 10% of companies so much as enquire about Health & Safety and the vast majority do

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

not even check whether event providers carry adequate insurance. This is a shocking fact and I believe that it is caused by that dangerous adversary of risk management; assumption.

It is very difficult to a

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

Combination pro

ssess the size and standard of operation of a company from their website. Companies may look like an International operator with hundreds of employees when in fact they are a one man band trading from a spare

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

bedroom. It is essential that those booking events ask for reassurance in the form of copies of insurance cover documents, a written Health & Safety policy and Risk Assessments of each of the activities bein

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

g undertaken. This is a simple process; documents need to be seen and dates need to be checked to ensure that they are current.

Every activity provided by an event company should have a unique Risk Assessmen

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

t. In some cases there is clearly no risk at all, but still the procedure should be undertaken. In such cases the Risk Assessment will read ‘this activity has been assessed and classified as low risk’ with th

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

e name of whoever undertook the Risk Assessment. Companies should have a designated Health & Safety Officer who has undergone training and is sufficiently experienced to know how to recognize potential risks.

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

The key document to consider in this process is the Risk Assessment. This supports the investigation of the activity by the provider. A Risk Assessment ensures that potential dangers have been considered an

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

Following aspects would a

d steps taken to minimize the risk. Activities are then classified as low, medium and high risk. You may decide to avoid high risk activities on your event. Risk Assessments are living documents, in that an a

dd to the challenges in developing combination products:

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

ctivity provider should update it along with lessons learned as they practice.

If you are choosing medium or high risk activities it would be prudent to ask how many times the activity company has provided t

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

hese activities before. You may wish to avoid undertaking a high risk activity run by a company who was providing it for the first time.

The corporate event industry is divided into companies operating on st

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

atic sites and companies with a mobile operation who travel to venues. In most cases the event will be held in a field, often close to the hotel at which a client is staying. It is essential that any company

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

providing such events visits the site before hand to assess the land. It is not enough to use a map as there can be trees in dangerous locations, particularly for motorized vehicles such as quad bikes or dune

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

Professional from academic institutions, pharmaceutical industries, health care indust

buggies, or holes in the land which make it dangerous for activities. In some cases land can be contaminated with dangerous scrap metal or broken glass.

If an event is water based the water should have rece

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

ntly been tested. In water parks or regularly used locations this is likely to be a regular undertaking, but in some cases a pond or waterhole will be used for bridge building or raft racing. This should be t

.

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

ested for bacteria or other dangerous deposits. It’s a risk to simply use an area of water without considering this.

There are many other areas that a sound Health & Safety procedure will cover. It takes tim

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

Companies that provide selfless information through particip

e and effort to set one up and it needs to be maintained and updated on an ongoing basis. All event management companies should have one in place and they will only improve if more clients demand to see them.

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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