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Have you ever seen the movie “Office Space?” If you have worked in any facet of corporate America and haven’t seen it, I encourage you to do so. It is a comedy about a guy who rises up to rail against the hopelessly corporate fictional enterprise, Initech. The cast of characters includes the boss w

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

ho always wants you to work overtime, the employee with too many bosses, two clueless consultants and one character who just wants his “stapler” back. As outrageous as the film’s plot is, it does reveal some of the secrets to getting ahead in the corporate world.

I have known many incredibly capab

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

Examples of combination products may in

le people whose abilities weren’t being noticed or recognized, simply because they did not know how to navigate a corporate environment. If you were raised in a suburban, professional household, some of these things are old hat. However, if you were raised in different circumstances, as many of us

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

were, much of these customs or the “corporate culture” as a whole, may seem as natural as two left feet.

As with everything in life, work means finding the right balance. If we are off balance in any direction, our life suffers and we are unable to achieve our true potential or joy out of what we

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

are doing. For example, a workaholic is often a doormat to their job, loving it but having a home life that suffers. Alternately, a person who salivates at the though of 5pm can’t possibly be a person who enjoys what they are doing. And when we don’t enjoy what we’re doing, we don’t do it as well a

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

Combination pro

s someone who does – and our work suffers.

5 Things to Avoid

Taking it Personally

I have a friend, let’s call her Sally, who used to write people letters at the office whenever she was offended by them or when she was afraid she offended them. She was an assistant in her department

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

and lacked confidence because she didn’t have the education or rank that her co-workers had. However, what she didn’t realize was that she had the talent, drive and intellectual capacity to outperform every other member in her department.

What am I really saying here? Education is important. We s

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

hould strive for it, hunger for it and value where it can take us in our personal and professional lives. However, just because a person doesn’t have a formal education doesn’t mean that they don’t have what it takes to do a job. Mistakes are going to happen on the job, some people aren’t going to

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

like you and sometimes people may even say things that hurt your feelings. Just know that while your feelings are valid and important, you need to handle conflict in a straight-forward, professional manner. Look at the situation at hand. Is there anything you can learn from it that will make you a

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

better worker? Could there be another reason for your co-worker/boss’s comments or attitude? What can you do to show this person that, while you are not willing endure any rude or unprofessional comments, that you appreciate their input and will take them into consideration?

I once had a co-worker

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

who worked in a legal department of a publishing company. She received calls all the time from irate authors who hadn’t received their payments who would curse her out. After trying every possible way to calm them, with grace, she would simply reply over and over again, if necessary, “well, I’m so

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

Following aspects would a

rry you feel that way.” Once she hung up the phone, she knew that she had done everything she could and that she had no control over their feelings. This enabled her to let it go.

The “me” Complex

I am sure that your needs are at the top of your list – and let’s face it, in most cases they

dd to the challenges in developing combination products:

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

should be. However, do not expect your employer to feel that way. You are not irreplaceable – no matter how well you think you do your job. An employee who is stuck in their own world of me, mine and myself, signals to an employer that they are not thinking of the business and the bottom line that

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

keeps everyone employed.

Items that fall under this category include; personal life excuses for not getting work done, a never-ending tirade of personal issues interfering with job performance and letting your employer know the intimate details of your life without being asked.

Constant Compl

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

aining

Just about everyone has worked with a complainer. If they won a Rolls Royce, they’d kick the tires and ask about the gas mileage. Then they would have a fit when they found out they would have to pay for their own gas.

This person could be the most talented person in the company but, i

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

n most cases, they will never advance because their “can’t do” attitude will precede them wherever they go. True leadership requires the ability to motivate others and to serve others in a positive way that enables and inspires them to do the best job they can do.

The Doormat Syndrome

Goin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g beyond the call of duty is necessary if you want to get ahead at work, but there is a line that should not be crossed. Make reasonable limitations about your time and what you are willing to do and STICK to them. This will show integrity and a good boss will respect you more for this. The doormat

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

does everything without even thinking about it and often ends up getting walked on in the process.

The Flirt

Sure, you can get what you need more quickly if you strike up a charming discourse with the people who really matter – we’re talking about the office management personnel and techn

.

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

ical gurus. This is encouraged because these people are often the hardest working, yet least valued members of an organization. However, the big no-no is even the appearance of “sleeping your way to the top.” Even if it is innocent, perception is truth to many. And who wants to be perceived as some

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

Companies that provide selfless information through particip

one who slept their way to the top? Even if you get the title, you won’t get the respect. So don’t go there. Use your feminine whiles to make quicker, more effective decisions, to handle workplace friction and to increase efficiency in your organization. You’ll respect yourself more in the morning.

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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When it comes to manning your company, you should aim to know absolutely everything that goes in and out of it. From how much profit the company makes monthly to employee satisfaction...

The configurable auditing features available in some automated records management systems. The advantages of using an audit package in conjunction with a records management system are illustrated.

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