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The job of safety director can and should be one of the most rewarding jobs in industry. After all, you get paid to make sure people have a happy and safe day at work - or at least that they leave

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

with the same number of fingers and toes that they come in with.

If you are taking over an existing program, you are gong to be expected to improve no matter how good the previous person was. If y

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

Examples of combination products may in

ou are just starting a new safety program, you will be faced with the challenges of changing the way people think about safety.

Here are some important tips that will help guide you to having a su

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

cessful experience as a safety director:

Know your personal goals. In order to feel successful in any job, you have to know how that job fits into your own life goals. Know what your exp

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

ectations are of your self. Make sure you have personal goals that are satisfied by this job.

Know and understand your company’s stance on safety. While most major companies have a genuin

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

Combination pro

interest in keeping their employees safe and highly motivated, some companies have safety programs because they have to. Again make sure the companies goals align with your personal goals.

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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

li>Get to know your workers. Spend time on the factory floor. Make the workers feel comfortable talking to you. You will get a lot more cooperation from them in times of change if they feel you rea

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

lly care about their safety.

Really care about the safety of the employees. Remember that assembly line workers have a different attitude toward work than professionals. While you may nev

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

r consider doing an unsafe act at work, many employees will do whatever it takes to keep a job or to look like a hero at work. Understand the motivation of the employees and take the precautions ne

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

cessary to protect them.

Focus on real problems. While the number of potential hazards in a facility are infinite, there will likely be a few major areas that cause real problems for empl

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

yees. Start in these areas before moving on to far fetched potential problems. I once had a maintenance worker injured installing a guard over something that had been exposed for twenty years and n

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

Following aspects would a

ever caused an injury.

Network with other safety professionals. You will gain knowledge beyond value by talking with others who are faced with the same problems you are. Find out what wor

dd to the challenges in developing combination products:

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

ks and what does not work in safety networking meetings. You can join a local group of safety professionals as well as communicate with others safety directors within your company.

Always

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

be loyal to your company. Resist the temptation to whine and complain because your company will not give you all the resources that you ask for. Never reveal any potential hazards or violations out

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

side your own company. If you have a problem with the way things are done, discuss it with your boss or seek another job. Don’t set yourself up to be the scapegoat when things go wrong.

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

cept the responsibility for the safety of the workers. Don’t be afraid to stop a machine or a job that is being preformed in an unsafe manner. If you have taken the time to get to know the workers

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

Professional from academic institutions, pharmaceutical industries, health care indust

and the jobs that they perform, you decision will be respected.

Keep accurate records. Even if you think your safety numbers will look better if you don’t record certain data, you will ne

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

ver be able to make good decisions without good data.

Get a mentor or a coach to guide you. Handling safety issues can be very stressful when things go wrong. You need someone you can tru

.

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

t to share ideas and concerns. A mentor or coach can also help you maintain focus on your own goals so that your work fits into living a satisfying and successful life. Your mentor or coach c

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

Companies that provide selfless information through particip

an also be a big help at salary review time to assist you in wording your list of accomplishments so that your employer understands how valuable you are to the company’s bottom line.

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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