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Advice You - Hiring Your First Employee
Whether you are just starting out and need to hire an employee for your new business or your b
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
usiness has grown and the need for help is eminent, there are several things you need to know
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
efore you jump into the hiring process. This series of articles will provide you with the inf
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ormation you need to meet this challenge and avoid the pitfalls.
First let’s define an employ
First let’s define an employ
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e. The IRS defines an employee as a person you hire whose work is controlled by you including
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
both what is done and how it is done. Whether you pay this person hourly, daily or weekly or
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
by the job are immaterial. Both part-time and full time employments are included in the defin
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
tion.
An employee differs from a sub-contractor. A sub-contractor will work for more than on
An employee differs from a sub-contractor. A sub-contractor will work for more than on
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
client, have a defined business, advertise for work, have signage, have general liability ins
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
urance and perhaps workman compensation insurance, will have a business phone, business cards,
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
stationery and contracts. A sub-contractor will also make their own hours, determine the work
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
to be done and will provide their own tools and materials necessary to perform the work. If n
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
one of these criteria are in play, you are hiring an employee and thus need to meet all of the
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
reporting and legal requirements of an employer.
Now you have made your decision to become an
Now you have made your decision to become an
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
employer, where and how do you find a quality employee? You have several options available to
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
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
you. Word of mouth, advertisements, your state employment agency, private employment agencie
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
, local colleges and schools, professional and trade associations, friends and family are all
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ood sources. Which you use – and you might use more than one source to find your dream employ
.
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
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
ee – will depend upon your community, your network of associates, your budget and of course th
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
type of employee you are looking for.
Next we will discuss the mechanics of a good interview
Next we will discuss the mechanics of a good interview
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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