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If employers and employees work together to reduce the number and severity of accidents and incidences in the workplace, everyone benefits from it. From the employer

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

s point of view, it is an important way of reducing legal exposure and from an employees point of view, it means ensuring your health and wellbeing are protected, bo

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

Examples of combination products may in

h for your sake and for those of your family and friends.

Here is a quick and easy three-step plan to help you work together to create a safer workplace for everyon

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

e.

Step 1: Locate any hazards

How do you locate hazards in the workplace? Follow these simple guidelines:

Start by prioritizing safety as an iss

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

e. Employers should appoint people to coordinate safety issues and make their senior management accountable for safety in the workplace. If this is not being done, i

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

Combination pro

may be possible the employer is in breach of the applicable Australian state legislation relating to workplace safety.

Start talking amongst yourselves, and active

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

ly looking at your organization to check whether or where the potential hazards exist. This might include creating a Safety Action Plan. Look at your organizations p

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

st. What injury records exist or what type of claims has been made before?

Take a look at your industry. What are the causes of injuries and fatalities? Not all inj

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

ries are immediately obvious, so look for long-term effects as well, such as exposure to chemicals.

By doing all of these activities, and compiling a list of potent

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

ial areas to examine, you have made a great start to addressing any hazardous conditions in the workplace.

Step 2: Assess the risks for their seriousness
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
trong>

Your highest priority hazards to fix are those that have the potential to cause injury or disease, or pose a risk to public safety.

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

Following aspects would a
possible hazards vary in their risk to employees. For instance, some potential hazards may cause cuts and bruises which are significantly less threatening than a ser
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
ious or fatal injury. Some hazards will be everyday occurrences while others may be intermittent or occur once every now and then. You need to prioritize your workp
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ace risks based on their seriousness and frequency, and look for interim measures you can put in place while a permanent solution is being developed and implemented.
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

Step 3: Fix Your Workplace Safety Problems

The most important step of all is to fix your workplace safety risks or, if they cannot be removed comp
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
letely, ensure you have an appropriate way to control it. Some risks may be easily removed. For instance, if you see cabling that has the potential to trip someone,
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
emove it or affix it in such a way that tripping risk is reduced. Chemicals can be stored in special ways to remove risk and supplying the right breathing apparatus
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
or employees is an important first step in ensuring that staff is protected.

When certain risks exist that cannot be totally removed, look at work procedures to see
.

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
whether there are ways of altering how the work is done so that the process is safer. Protective clothing is extremely important in many of these environments.

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

Companies that provide selfless information through particip
how easy it is to think safety in the workplace? There is no excuse why you are not starting to make your workplace safer today and every reason why you should begin

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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Just Other Articles - Staying Safe In The Workplace – A Three Step Plan

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