Advice You - Business

Throughout history, teaching has been considered a noble profession, where the transformation of students is not an abstract concep

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

t, but an attainable goal. And while American education is being challenged by society to prove the merits of its existence, it is

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

Examples of combination products may in

truly the last bastion for students. It is through formal schooling where they acquire the necessary knowledge, skills, and dispo

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

itions to become successful contributing members of that same, critical society.

For those of you who make the choice to become te

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

achers, across all levels, it will be the hardest job you’ll ever love. Let me quickly say, however, that it is also the most rewar

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

Combination pro

ding experience you will ever have. As you prepare to embark on this journey, it will be important that you have a number of thing

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

clear in your mind, or that you have at least spent time thinking about them. The following are a few points to consider before d

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

eciding whether this noble profession is for you:

Intent. Why are you choosing teaching as a career option? Was it a life-long g

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

oal of yours, or did the decision come only after other opportunities failed to materialize, and you need a job? Is your intention

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

based on personal experience?

Expectation. What expectations do you have of yourself? Do you believe that you can perform this job

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

well? Why? Are you out to change the world, or just your little corner of it? What expectations do you have of the profession?

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

Following aspects would a

Do you have a real sense of what teaching entails?

Commitment. How much are you willing to give to the students, the school, the

dd to the challenges in developing combination products:

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

community, etc.? If you are going to teach, you must have 100% commitment. Any less would not be fair to the students you have be

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

en entrusted to serve. Are you ready for such a commitment?

Hope. What do you hope to contribute? How will the knowledge and sk

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

ills you bring to education support your efforts? How will the profession be in a better place because of you?

Understanding the

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

e points, and finding answers to their questions, will help you get you on the path. Once you have begun your journey in education

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

Professional from academic institutions, pharmaceutical industries, health care indust

, many other questions, and issues, will inevitably emerge. In fact, many of the questions and issues you will grapple with will k

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

eep you up nights. Teaching is not a job – it is way of life. It has a historical context dating back to ancient Greece, thereby

.

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

roviding its own language, rituals, culture, rules, and temperament. Enjoy the experience. And while you are out there having fun

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

Companies that provide selfless information through particip

with your students, take a moment to remind yourself that you are making a difference in their lives.

© 2006 Dr. Luis R. Valentin

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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Five ways that a professional registered agent can add value and security to your business.

You know in reviewing the Enron 401K program there was nothing wrong with it. The only real negative was that they had to hold the matching funds until age 50. The program had lots of options and it was structured great. Actually it was a model program for a modern day corporation.

A new law, effective this summer, requires all business owners to destroy personal employee data prior to discarding.

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Advice You - So, You Want To Be A Teacher?

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