Tags |
|
|
Links |
|
|
Digg It - Employees - Your Best Resource or Biggest Threat?
As a small business owner, how much thought do you give to human resources (HR) compliance? Probably not a lot and that's not uncommon if you only have a few employees. There are legitimate reasons why you haven'
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
t felt the need to spend time on HR, but there are even more compelling reasons why you should.
I'll be the first to admit that the chances are slim to none that someone from the state or federal government will
I'll be the first to admit that the chances are slim to none that someone from the state or federal government will
; 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
draw your company's name out of a hat and decide to audit your employment practices. It's not a big secret that the government is severely understaffed for this type of activity. The people they do have are quite
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
busy with much larger corporations. But does this mean you can just close your eyes to HR compliance and run your business in any manner you choose? The answer depends on how much risk you like to take. Are you w
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
lling to risk lawsuits or fines that may seriously damage your business?
For most small business owners, your success depends on your employees. While that may be a scary thought if you haven't hired good employ
For most small business owners, your success depends on your employees. While that may be a scary thought if you haven't hired good employ
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
es, it is a fact. Every person who has started a business comes to the realization that, for continued growth, help is needed at some point. Although a better way to phrase that may be that at some point you real
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
ize your time could be better spent on building the business instead of on work that can easily be done by others. Employees are a great resource; they are often your biggest resource. However, as a small busines
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
owner, your employees are also one of your biggest legal risks.
The harsh reality is that, particularly in California, employees are more aware of their rights than ever before ... and employees are more litigi
The harsh reality is that, particularly in California, employees are more aware of their rights than ever before ... and employees are more litigi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
us than ever. What this means to you is that an employee can draw the government's attention to your company with a simple phone call.
That employee who doesn't feel they are paid fairly? A call to California's
That employee who doesn't feel they are paid fairly? A call to California's
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
epartment of Labor could easily start an investigation of your pay practices. That employee who laughed with the group over that joke with sexual overtones? You could be faced with accusations of sexual harassmen
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
. Employees have easy access to authorities who will start an investigation. What can you do to protect yourself and your company? Think HR.
I want you to think about HR in a different way than perhaps you have
I want you to think about HR in a different way than perhaps you have
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
in the past. It really wasn't designed with the purpose of driving business owners crazy. Personally, I've always thought of HR management as a tightrope; keeping the balance between what employees want and what
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 company can provide. The first step in this process is making sure the employees know the rules. After all, you can't expect them to do something or act in a particular way if you haven't told them what it is
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
ou expect. Yes, I'm a huge advocate of employee handbooks.
However, not just any employee handbook works. You need one that is personalized for your company. It must have specific language that makes it clear wh
However, not just any employee handbook works. You need one that is personalized for your company. It must have specific language that makes it clear wh
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
t you want, such as calling in an hour before the shift starts if they will be late or absent. I've seen too many handbooks that merely tell the employee to call in as soon as possible. And I've known employees w
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 feel that is two days later.
Providing specifics in writing can serve you well in two areas. First, it gives the employee a reminder of your policies in writing so there is no opportunity for misunderstandings
Providing specifics in writing can serve you well in two areas. First, it gives the employee a reminder of your policies in writing so there is no opportunity for misunderstandings
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
. It's hard to discipline an employee for not behaving in a particular manner if you don't have any written documentation that they were told it was expected. Having your policies in writing saves everyone a lot
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
f time. Second, it also gives your supervisors information about what legal rights your employees have and how your company handles any issues. You don't want an inexperienced supervisor doing the wrong thing wit
.
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
an employee. Written policies can help a new supervisor learn the ropes of management and legal compliance.
The bottom line is that an employee can be your best friend and resource... until they feel they aren'
The bottom line is that an employee can be your best friend and resource... until they feel they aren'
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
being treated fairly. Then they can be your worse nightmare. This is one of those times where you need to put resources in place that help your business and, ultimately, save you a great deal of time and trouble
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/20633/diggit-Employees--Your-Best-Resource-or-Biggest-Threat.html">Employees - Your Best Resource or Biggest Threat?</a>
BB link (for phorums):
[url=http://www.diggit.org.ua/article/20633/diggit-Employees--Your-Best-Resource-or-Biggest-Threat.html]Employees - Your Best Resource or Biggest Threat?[/url]
Related Articles:
American Business Principles Refined
Tips and Tricks for Finding a Conference Hotel
Branding 101: Why It's Critical to Business Success and How to Do It Right
Bookmark it:
|