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ArticlePedia - Manage the Transition to Your New Job
Consultants are often involved in a change in job assignments. Some jobs 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
ke more time then others. Some consultant have different assignments at the
; 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
same time, but a new assignment always brings a introduction period with it
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
Not only consultants, but everyone involved in a job switch will be faced
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
with such a transition. How should you handle such a period?
As any change
As any change
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
, reserve time for it. Reserve time for “nothing special.” These day
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
where you are changing to another (work) environment can not always be pla
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
ned. You do not know what to expect, you should merely adapt to the situati
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
n. Although you can not plan this transition, make sure you have enough att
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
ention to focus on this new job.
Free yourself from other assignments.
Free yourself from other assignments.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
oose ends from previous jobs could absorb quite some energy. These will
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
inhibit a swift transition to your new assignment. If you know in advance a
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
out the switch, make sure you finish current demands and activities.
Take
Take
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
your time to learn about the new place, the people and the organization and
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
do not sow expectations. It is easy to start a new job with extra en
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
rgy. But do not forget that you have more adrenaline only because of the tr
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
nsition and because you start with a clean slate. It is better to make no m
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
istakes than trying to run too fast.
Of course this will apply for everyon
Of course this will apply for everyon
.
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
who is dealing with a switch of jobs, not only the consultant, although he
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
or she will be more often involved in this kind of change.
© 2006 Hans Boo
© 2006 Hans Boo
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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