Advice You - Business

What is being professional? Do you think you measure up? What separates a professional from an amateur? In days gone by, the definition was simply this -- if one was paid for something regularly, o

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

ne was professional. Something followed for a hobby, or for fun, and not paid, was considered amateur.

Through the media and at school and college we are all repeatedly encouraged to be profession

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

Examples of combination products may in

al in our business dealings and working lives. What does one do to actually be professional? And just as importantly, what does one not do?

The dictionary definition of ‘professional’ is “…enga

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

ging in an activity as means of a livelihood. Extremely competent in a job. A person who conducts his business in a field also pursued by amateurs. A person who engages in an activity with great c

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

ompetence.”

But is it just competence enough in isolation? Definitely not. Making yourself approachable and reasonable, and giving respect to other people is important. Ensuring that you present y

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

Combination pro

ourself in a businesslike manner, whether in person, on the telephone, or in writing, is essential. Turning up for an important business meeting with your favorite editor in torn jeans and dirty sh

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

oes is just sloppy. Being lazy and blaming lack of time or pressure of other commitments is definitely not professional. These constraints should not stop you making sure that you always project a

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

businesslike appearance.

Perhaps the most vital aspect of being a professional is knowing your subject from A to Z. Do your homework and know exactly what you are talking about. Telling people

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

B.S. may come easily to you, but being found out in a half-truth or bluff will lead instantly to a loss of credibility, putting in jeopardy your professional relationships while also compromising 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 integrity.

Something for everyone to be extremely careful about, not just writers, is not putting anything on paper unless one is completely and utterly comfortable with it. This applies equal

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

ly to websites and particularly to email. Never send anything in writing when angry. Hold fire on any emails. Type out your frustration in Word, then leave it overnight to simmer. By morning you

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

Following aspects would a

should have cooled down sufficiently to review your writing in a more rational manner. Sometimes printing out your rantings, then tearing them into a thousand pieces works well.

Another golden ru

dd to the challenges in developing combination products:

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

le to being professional is not to commit to writing anything with which you are not totally comfortable. The acid test is to imagine your grandmother reading it. Or imagine it on the front page o

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

f a magazine or newspaper. Importantly, being accurate and taking responsibility for your decisions and actions is also the mark of a professional person. In developed countries, a firm grip on p

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

unctuality is important in a professional.

Sometimes being professional means knowing who best to delegate tasks to, and then having the courage to stand back. Being magnanimous and giving credit

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

where credit is due is also a major part of being a true professional.

Looking professional is also part of it. To create a truly professional image, ensure you always wear clean and appropriate c

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

Professional from academic institutions, pharmaceutical industries, health care indust

lothing, paying attention to grooming and personal cleanliness. Being reasonable, and fair, is important, but can be difficult if you are the only one doing it.

Being professional does not mean le

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

tting other people take advantage of you. Sometimes you may not be able to say what you would like, and holding your tongue and biting back certain comments may be difficult at times.

To sum up, i

.

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 would seem that being categorized as professional means showing you have that rarest of commodities, common sense, and then, actually using it. Another major part is being adult, being considerate

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

Companies that provide selfless information through particip

towards other people, and demonstrating self-control. No-one said it was easy, but it is definitely something worth striving for if you wish to be seen as a true professional, in a sea of amateurs

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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