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So many people are concerned with lowering their TCIR number or simply meeting their saf

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

ety goals that they loose sight of the issue of actually making the workplace safer. I

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

Examples of combination products may in

have even seen this attitude expressed through some safety governing bodies in my years

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

working with safety.

If you want to improve your safety numbers here are some tips:

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

Make employees scared to report accidents by making veiled threats like drug t

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

Combination pro

sting, punitive accident investigations, loss of privileges, long reporting forms etc.

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

Make employees scared to report injuries through peer pressure. Establish an

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

incentive plan for the whole group so that the benefit will be lost if any one-person re

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

ports and injury.

Reduce the number of recordable injuries by working with yo

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

ur attending physician so that he does not write a prescription or otherwise trigger a r

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

cordable event.

Lower TCIR by inflating the number of hours worked. Since th

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

Following aspects would a

e hours worked is in the denominator, make this number as large as possible. Include al

dd to the challenges in developing combination products:

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

l office staff, salespeople, interns, co ops, contractors, anyone who can have any conne

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

ction with your group that are not likely to report an injury.

Include safety

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

performance improvement to each supervisor’s salary review. He will make sure that empl

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

yees are discouraged from reporting injuries.

Assume every employee who repor

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

Professional from academic institutions, pharmaceutical industries, health care indust

ts an injury is faking and plans to sue the company. Treat each case consistently and t

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

he word will get around.

Spend hours reviewing the OSHA or corporate rules fo

.

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

r what constitutes a recordable event. Get to know every loophole for how to avoid list

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

Companies that provide selfless information through particip

ing it on the chart. Document why you did not record them in case of an audit.

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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In the modern world today, many people are busy pursuing many things in their lives, thus the need of an effective time management is never been so crucial than now.

As I have seen over the years the workings of companies large and small I have always been surprised at how few CEOs and MDs really get their monthly reporting information set up to help them run and have control of the business. So here’s my check list on what I believe you need do: To run your business effectively it is essential that you have the right financial and other key performance indicators provided to you - regularly and you need to remember that (regardless of what others may think) this information is there simply to help you run the business.

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