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Just Other Articles - Performance Appraisal - Should I Go To HR If I Disagree With My Review?
Question: Should I Go To Human Resources To Protest An Evaluation I Believe Is Unfair?
It's difficult to answer the ques
It's difficult to answer the ques
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
tion without knowing how human resources works in your company, your relationship with the manager, and the nature and us
; 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
of the appraisals. But here are a few things to consider.
It is probably within your rights to approach human resources
It is probably within your rights to approach human resources
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
with your concerns about a performance evaluation you feel is unfair. However, whether this will result in good outcomes
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
r not is another question. It is true that human resources should be interested and concerned if you feel you have been e
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
aluated unfairly, but it doesn't always work out.
Probably your best step is to try to deal with your concerns directly
Probably your best step is to try to deal with your concerns directly
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
ith the manager or supervisor who has evaluated you. Make sure you have indicated your disagreement on any paperwork (eva
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
uation forms and documentation). If you can't make any progress with your manager, then it's fair to inform him or her th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
t if the two of you can't resolve the issue between you, that you will approach human resources for clarification of the
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
rocess and your options. Don't phrase that as a threat.
If you approach human resources, it's better to ask for clarific
If you approach human resources, it's better to ask for clarific
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tion rather than launch a full scale accusatory rant about your manager. If HR sees you as reasonable in approach, they a
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
e more likely to consider your concerns.
It is good to remember that many human resource professionals are committed to
It is good to remember that many human resource professionals are committed to
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
he welfare of employees, but that their prime role is to serve the overall good of the company, and they are bound by for
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
al and informal policies and procedures, and internal politics. Also, since they aren't as close to you and your performa
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
ce as a manager or supervisor, they will tend to be hesitant to intervene too directly.
Finally, if you believe that you
Finally, if you believe that you
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
evaluation is negatively affected by managerial actions that are illegal (discrimination of various types, sexual harras
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
ment), then it may be better to approach HR earlier in the process. HR tends to look at potentially illegal managerial de
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
isions more seriously than differences of opinion that have no legal implications.
(c) 2007, Robert Bacal, Bacal & Assoc
(c) 2007, Robert Bacal, Bacal & Assoc
.
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
ates. You are welcome to "reprint" this article online as long as it remains complete and unaltered (including the "about
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
the author" info at the end) all links are made live, and this copyright notice and indication of authorship are included
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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