Main Subject - Business

Presenteeism is alive and 'not well' in many businesses today. It will visit your business or may even be present as you read this article.

Presenteeism

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

may be described as 'attending the workplace with minor or serious illnesses' when in fact your employee or you should be away recovering'!

It’s a fact

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

Examples of combination products may in

of life that when we don’t feel good we don’t operate at our best!

Many of us have observed workers and co-workers who have come in for the day and seem

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

d present at the job only to observe a decrease in productivity or an overrun of deadlines. Some of us would have experienced this ourselves.

Employees

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

r managers attending your workplace with minor sicknesses such as asthma, irritable bowel, migraines, arthritis, stress, fatigue may cause your business

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

Combination pro

erious risk such as legal claims, productivity loss, declining employee morale and a occupational health and safety problem.

With more seious illnesses

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

uch as surgery recovery the effect on your business may lead to serious consequences.

In our business culture of lean and mean, fewer people more work,

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

any employees come to work ill just to protect their jobs. After all there are bills to pay, medical expenses, school fees and the list goes on.

With ma

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

y businesses reliant on team structures the presure by an ill employee to 'not let the team down' is a very real pressure. You can train your team to rec

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

gnise these factors and save your business considerable grief.

Presenteeism is a concern in our workplaces today as pressure continues on individuals, f

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

milies and enterprises to remain competitive. Fear is a terrible negative motivator! In the end your business will suffer consequences.

By way of exampl

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

Following aspects would a

; at a company I worked for in a senior management capacity we disturbed an executive who had his door closed for quite some time. A staff member of mi

dd to the challenges in developing combination products:

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

e had a master key and required access to the executive’s office to get some material and on entering disturbed the executive who was sleeping under the

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

esk on the floor. He was recovering from eye surgery and needed 5 days off on Doctors orders!

From our experience many workplaces do not have the human

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

esource infrastructure or capacity to ensure that they comply with the myriad of regulations and complex legislation that is required to protect your bus

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

ness interests in today’s workplace. However, you are not alone and there are practical solutions for your business.

A few questions could be

1. Have I

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

Professional from academic institutions, pharmaceutical industries, health care indust

noticed present employees who are not performing because of illness?

2. Am I actively looking after their welfare?

3. Do I know what my obligations are

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

4. Have I policies and procedures to circumvent organisational illnesses such as stress?

5. Do I understand the risk involved in allowing the person 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

remain at work?

From our experience most employers are not aware of their obligations, consequences and risks and ignorance of these issues is ‘no defe

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

Companies that provide selfless information through particip

ce’ in the eyes of the law. There are practical solutions to minimise your risks and give your biz momentum. For more information see www.biz-momentum.co

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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