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Advice Pool - How to Tell if You are Fired and Just Don't Know It
No one should be fired and be surprised about it. There are always warning signs. The trick is in learning how to recognize the signs and to
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
have a plan of action. Many time subtle hints are given that allude to the ax falling.
Here is a checklist of early warning signs that add
Here is a checklist of early warning signs that add
; 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
up to impending doom:
Subtle
* You are asked to update management on all your currents projects.
* You no longer get asked to join meeti
Subtle
* You are asked to update management on all your currents projects.
* You no longer get asked to join meeti
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ngs that you have always attended in the past.
* You are pushed to wrap up longstanding projects.
* You have a general sense of
* You are pushed to wrap up longstanding projects.
* You have a general sense of
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
unease at work.
* Your expense reports are closely scrutinized and require explanations.
* Things that were expensed previously a
* Your expense reports are closely scrutinized and require explanations.
* Things that were expensed previously a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e now being questioned.
* Time off for personal reasons is denied or questioned.
* Your office space is downsized or moved to a
* Time off for personal reasons is denied or questioned.
* Your office space is downsized or moved to a
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
distant location.
* You are asked to transfer to an out of the way facility. * Your duties are changed to some not critical to t
* You are asked to transfer to an out of the way facility. * Your duties are changed to some not critical to t
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
he company’s success.
* You are asked to prepare a job description and explain your duties.
* You walk into a room and there is
* You are asked to prepare a job description and explain your duties.
* You walk into a room and there is
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
silence.
* Performance reviews are either canceled or rescheduled as an emergency.
* Communications that were by mouth about yo
* Performance reviews are either canceled or rescheduled as an emergency.
* Communications that were by mouth about yo
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
ur performance suddenly appear in written form.
* Your income is frozen for no apparent reason. * No one invites you for drinks
* Your income is frozen for no apparent reason. * No one invites you for drinks
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
lunch or social events.
* HR wants to meet with you to update their records.
Boss
* Your boss meets with you less frequently
Boss
* Your boss meets with you less frequently
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
with a much shorter duration.
* You are suddenly given a performance review.
* Your boss seems distant and unavailable.
*
* You are suddenly given a performance review.
* Your boss seems distant and unavailable.
*
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
Someone sees your boss outside the office with what looks like a job candidate.
* Your boss seems inordinately interested in your con
* Your boss seems inordinately interested in your con
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
tacts and resource base.
* Your boss starts making your decisions and directing outcomes.
* Your boss seems particularly intere
* Your boss starts making your decisions and directing outcomes.
* Your boss seems particularly intere
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
sted in your project outcomes.
* Management is conducting interviews for a job that is similar to yours.
* You start reporting
* Management is conducting interviews for a job that is similar to yours.
* You start reporting
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
o a new boss who is a more junior manager.
Subordinate
* A new committee is formed to restructure the department and you are not on it
Subordinate
* A new committee is formed to restructure the department and you are not on it
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
.
* You are no longer copied on memos and internal communications.
* Other employees seem uncomfortable in your presence.
*
* You are no longer copied on memos and internal communications.
* Other employees seem uncomfortable in your presence.
*
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
You are asked to explain your job to a subordinate.
If you checked one or none of these items then you are probably safe for the time be
If you checked one or none of these items then you are probably safe for the time be
.
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
ing. If you answered yes to a couple of these, it could be an early warning sign that there are problems ahead, and your boss is laying the
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
ground work.
If you answered yes to five or more, you better begin to update your resume. You are probably fired and just don't know it yet
If you answered yes to five or more, you better begin to update your resume. You are probably fired and just don't know it yet
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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