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Digg It - Make Annualised Hours Part of Your Lean Office Programme
Most businesses have lulls and peaks throughout their financial year. We have all been in the situation where some
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
weeks we have too many staff for the workload in hand and other weeks where we could do with army of people to he
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
lp out. One of the possible solutions is a system we introduced more than 6 years ago called ‘Annualised Hours’.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
Since that time our electronics business in Bedford, UK employing about 80 staff has enjoyed many positive benefit
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s.
The way it works is simple. Each person works a set number of hours on an annual basis. In most businesses thi
The way it works is simple. Each person works a set number of hours on an annual basis. In most businesses thi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
s translates to a set number of hours per week or month. Where the annualised hours system differs is that it look
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
s at the annualised figure as being the most important one and how that is achieved on a weekly or monthly basis i
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
s mutually agreed between employer and employee with the confines of legislation.
In our case rather than work at
In our case rather than work at
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
set week of say 37 hours the annualised hour systems balances the weekly or monthly hours to reflect actual work
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
load. For example, in some weeks our staff will work 32 hours but be paid for 37 hours and in others they will wor
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
in excess of 40 hours but still receive the basic 37 hours rate.
In return for this increased flexibility the st
In return for this increased flexibility the st
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
aff involved get an annualised hours payment which and also a share of the companies profits. The process being –
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
work smarter – more
profits – more profit share.
This ‘leveling’ effect has been a major contributor to our out
This ‘leveling’ effect has been a major contributor to our out
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
standing quality and delivery record. The system works because trained staff who would normally carry out certain
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
activities are on the whole available to cope with any surges in work load rather than using people who are simp
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
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
ly willing to work the overtime. In addition, because we are able to put
in more hours as and when the business
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
requires, delivery performance does not suffer but remains at its normal level.
Other more subtle benefits includ
Other more subtle benefits includ
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e staff being able to enjoy more time off during the summer
months (traditionally a quieter time of the year for
months (traditionally a quieter time of the year for
.
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
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
our business),absence levels have dropped to one third of previous figures and financially it is easy to both proj
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ect cash
flow movements due to more predictable outgoings and it significantly simplifies the payroll activities
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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