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Advice You - The Employee Manual: Mechanism for Avoiding Expensive Employee Disputes
A company’s employees often are its most valuable resource. Unfortunately, misunderstandings or disputes with employees also can lead to some of a company’s biggest and most expensive hea
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
daches.
Workers are turning to the courts in growing numbers with such claims as wrongful termination, discriminatory treatment, unsafe working conditions, and harassment. Employers, sob
Workers are turning to the courts in growing numbers with such claims as wrongful termination, discriminatory treatment, unsafe working conditions, and harassment. Employers, sob
; 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
red by huge jury awards, are increasingly coughing up thousands of dollars to settle even minor disputes. The economic effect of an employee lawsuit can be particularly devastating on a s
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
mall company.
Although there is no magic potion for eliminating employee disputes, a company can minimize the costly headaches by maintaining sound personnel practices. At the heart of s
Although there is no magic potion for eliminating employee disputes, a company can minimize the costly headaches by maintaining sound personnel practices. At the heart of s
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ch practices is the employee manual.
A well-written and carefully used employee manual can reduce the risk of lawsuits and can be a company’s first line of defense when disputes do arise.
A well-written and carefully used employee manual can reduce the risk of lawsuits and can be a company’s first line of defense when disputes do arise.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
In addition, an employee manual puts employees on notice as to workplace rules and provides guidance to supervisors and managers in implementing policies.
The lack of an employee manual
The lack of an employee manual
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
often results in ad hoc decision making, inconsistent treatment of employees, and misunderstandings and confusion as to personnel policies. In some cases, it may even lead to inadvertent
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
iolations of the law, resulting in unnecessary penalties and liabilities.
Small companies, in particular, frequently neglect to establish formal personnel policies. Not having the luxury
Small companies, in particular, frequently neglect to establish formal personnel policies. Not having the luxury
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
of a separate personnel administrator or personnel department, a small employer often takes the attitude, “I’ll deal with personnel problems if and when they come up.”
The problem with t
The problem with t
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
is approach is that complaints or disputes with employees invariably will arise in a whole range of areas, including matters such as absenteeism and tardiness, vacation and sick leave, per
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ormance and salary reviews, termination of employment, and harassment, to name a few. If an employer has not established clear written policies regarding such issues and consistently appl
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
ied those policies, a disgruntled current or former employee will be in a strong position to successfully challenge the company in court or before the Labor Commissioner, exposing the comp
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
ny to potentially major liabilities.
By taking a proactive approach and defining its personnel policies before disputes arise, a company not only avoids charges of arbitrariness and bias,
By taking a proactive approach and defining its personnel policies before disputes arise, a company not only avoids charges of arbitrariness and bias,
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
but also gains greater control over the workplace. Instead of simply responding to personnel problems one by one as they arise, a company can use an employee manual to take the initiativ
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
in establishing rules and setting priorities for its workers. Employees, meanwhile, are alerted as to what is expected of them.
To maximize the benefits of an employee manual, an employ
To maximize the benefits of an employee manual, an employ
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
r should take the time to carefully go through the manual with all new employees. In addition, feedback from employees should be encouraged to identify policies that are confusing or outm
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
oded.
By establishing and following a good employee manual, a company can ensure that it meets legal requirements and provide a basis for resolving misunderstandings or disputes with empl
By establishing and following a good employee manual, a company can ensure that it meets legal requirements and provide a basis for resolving misunderstandings or disputes with empl
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
yees. When forced into court, such a company also will be in a much stronger position to defend itself.
Moreover, a company that maintains a well-designed employee manual can expect impr
Moreover, a company that maintains a well-designed employee manual can expect impr
.
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
ovements in employee morale and efficiency. Workers who feel that they are being treated fairly and consistently are likely to be more loyal and more productive.
In sum, establishment an
In sum, establishment an
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
maintenance of a good employee manual is preventive medicine of the best kind and will pay many dividends in terms of professionalizing the work environment and minimizing costly disputes
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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