Main Subject - Business

It is becoming more common for employers to require employees to use their personnel motor vehicles for busin

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

ess use. Reimbursement for business use is commonly by way of a kilometre/mileage allowance or a general moto

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

Examples of combination products may in

r vehicle allowance for the year.

Did you know that you can be found vicariously liable for the acts and omi

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

ssions of your employees driving while driving a motor vehicle for work related business?

Even an innocuous

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

journey to pick up the daily mail can be fraught with risk!

I this day and age employees cannot always be re

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

Combination pro

lied upon to exercise discretion and common sense. It is therefore important that you take some human resour

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

ce risk strategies to ensure that any risk is mitigated or at least as much as possible.

Normally a business

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

motor vehicle policy should set the boundaries of employee use such as;

• Is the employee required to use t

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

heir personal motor vehicle, when and under what circumstances,

• Does the employee have comprehensive and r

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

eplacement insurance for their and any third party damage,

• How is the employee to be reimbursed,

• Is the

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

reimbursement subject to state or federal taxes,

• Does the employee warrant that they hold a valid drivers

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

Following aspects would a

license for driving a motor vehicle,

• What is your company policy for an employees’ loss of drivers’ licen

dd to the challenges in developing combination products:

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

se. This may be due to potential substance abuse, driving under the influence of alcohol or another offence.

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

• Does the employee loosing their license mean termination of employment as driving the motor vehicle is par

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

t of their tools of trade?

• Is the employee required to advise you of any license restriction and demerit p

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

oints accrued?

• Do you have a company policy that states that no parking fine, infringement, traffic violat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion or any other impost federal, state or local will be paid by the company?

By taking time to develop key h

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

uman resource policies and procedures and by inducting and training your employees you can reduce the potenti

.

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

al business and financial risk to your company.

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

Companies that provide selfless information through particip

ibe to our free monthly newsletter and receive a free template job description or employee performance review

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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Creativity can be defined as problem identification and idea generation and innovation can be defined as idea selection, development and commercialisation. From this simple definition, it is clear that certain cultural characteristics ought to be prevalent if creativity and innovation are to be maximised. And maximisation of these ought to be a priority for senior leaders, as those organisations that take them seriously, tend to be leaders in their field, tend to maintain their leadership position longer and are quicker to bounce back when competitors leap frog.

This article is about building successful project teams and focuses on the work done Meredith Belbin and John Hartson in the 1970s at Henley. This has now become a branded method and further details of how it can be applied can be found at www.belbin.com. Please note I have no connection with the Belbin Associates nor am I undertaking any MLM activities on their behalf. I include this reference as background for the interested reader. The insights gained from the Belbin approach have implications on the discussions about leadership and management. I will first give a short background of how the research arose and a brief outline of what I would consider key findings, and then I will draw out the implications of these in the debate about Leadership and Management.

“Benchmarking is a best practice tool. It is the process of identifying, understanding and duplicating proven practices from organizations that have consistently performed in the upper quartile of performance to improve your own businesses performance.”

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