Advice You - Business

Research indicates that we retain only 10% of what we hear; 20% of what we see; 65% of what we hear and see; but 90% of what we hear, see,

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

and do.

Every day at work we demonstrate Hear-See-Do when we use a combination of our knowledge, wisdom and skill to perform a task

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

Examples of combination products may in

or plan what we will do at a later date. This combination of intellect, insight and ability is called experience.

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

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One of my favorite sayings is, “It’s not what you know that counts; it’s what you do with what you know that counts.” In other w
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
rds, knowledge by itself is useless and unproductive. It’s only when we act on the data, facts and information and apply them in a particu
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
lar situation or circumstance that we in fact gain experience.

Here are a few simple yet profound truths about experience:

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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>We learn from our experiences. If they are positive, we tend to repeat them again and again until we become proficient and our 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
kill levels increase. If they are negative, we file them away in the back of our minds as cautions or red flags to be recall
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
d when a potentially dangerous situation threatens.

To experience is to be actively involved. An experience is gained whe
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
n we wholeheartedly become engaged in an activity or are constantly involved with people over a period of time.

Experiences ar
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e dynamic. It’s really up to us to take charge of our experiences and not let them just happen to us.

We are shaped by ou
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
r experiences. They are the sum total of things we have done, had done to us as well as our past thoughts and feelings.

W
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
impact others through our experiences. When we demonstrate an increased ability to work collaboratively with others, their experience
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
levels increase also.

Experiences are the foundation of success. Success results when we apply the invaluable lessons we
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
learn from our experiences and move forward. Failure happens when we allow our experiences to stop us or hold us back.

Wh
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
at About You?

Your work related experience is an integral part of who you are, and consists of every job or assignment you have ever h
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
d. Over the next week, take a small career break—a time-out to reconsider, reflect and focus on your career direction.

You determine how
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
much time your break will be. Timing is not as important as actually taking the break itself. Here are a few thoughts to get you started:
.

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

Reflect on the last time you took a good look at your work experience.

Identify 3 things you could do differently on
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
your job to positively impact your career.

Develop a plan to overcome the obstacles that are holding you back at work.

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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Advice You - Experience Hear-See-Do

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