Main Subject - Business

The truth is this: Whether you say "KSA" "KSA’s" or "Knowledge, Skills, and Abilities"?, You are ta

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

lking about the same thing. A KSA is simply an specialized essay required with most Federal Gove

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

Examples of combination products may in

rnment Resumes. Ok! no secretive almost answers here just the facts; a KSA is an essay that's i

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

t!

Are the KSA's Important to the Federal hiring process? Yes they are, they are Very Important. K

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

SA's are usually (there are some exceptions) rated on a points system, from 1 to 10. KSA’s are that extra

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

Combination pro

information used to separate the best candidates out of the pool of qualified applicants.

KSA's are writt

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

en in the first person, following the Challenge, Conflict, Action and Result format. Usually

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

there are a minimum of three KSA questions but there can be up to 10 or more depending on the vacancy ann

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

ouncement.

You do the math, 10 questions at 10 points each can add up to a whole lot of "You're Hired!

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

"

Your KSA's should be written to put a spotlight on how you are the best person for the position.

*

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

Knowledge is factual or "How To" data applied to the position.

* Skill is good old fashioned <

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

Following aspects would a

i>Know How in managing data, things or people.

* Ability is your talent or the knack
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
> you have in doing a mental or physical activity.

Ksa's are very detailed. they are much more in depth t
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
han the resume. You need to include one or two real life instances where you demonstrated the "Knowledge S
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
kills and Abilities" requested.

You should also use any points that help demonstrate your qualifications.
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
By that I mean items such as Training, Awards, Education, any Volunteer Work, anything that actually appl
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ies to the questions and has relevance.

I am a firm believer in having the KSA's done professionally. The
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
y are too important to leave to chance. Why risk it? Only bad gamblers will risk everything on a hope! The
.

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
good ones only bet on a sure thing.

Go for it, Work your hardest to get that Federal Government job, it
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
will payoff in the long run. Just don't cut corners in the process, unless of course you really don't care

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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Main Subject - Ksa's - The Hidden Truth

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