Main Subject - Business

It is likely that your company already has many rules and regulations that are in effect for its employees. Whether or not it's acceptable to smoke in the building, where and when employees are allowed to eat lunch, and even as simple as what time the em

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

ployee should report to work each day, there are many rules that most of the employees already know.

There may also be many other rules and regulations your company has that perhaps the employees are not as familiar with, and this means that each time a

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

n issue arises, the owner, the human resources director, or a manager has to figure out what these rules are as you go along.

On top of all the above, there may be laws at the federal, state, and local level with which your company is required to be in

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

compliance, and perhaps you or your employees aren't even aware of them. An employee handbook that is researched and properly formatted and written will help prevent future legal problems from arising, because someone in the company simply wasn't aware o

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

f a regulation that had never been communicated to them. With an employee handbook available, you now have an effective means of providing that communication, and protecting yourself, your company, and your employees from future problems.

Owners, manage

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

s, department heads, and human resources staff spend a large percentage of their time dealing with employee relations and relaying applicable rules and regulations to the staff. When there are no clear, written policies on employee and company benefits,

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

rules, and regulations, the people in charge are left having to answer questions and do a 'learn as you go' type of management system. This can result in uneven and sometimes unfair application of the rules and regulations throughout the organization, no

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

t to mention a loss of time and resources that must be expended to develop these regulations as the issues arise.

An employee handbook can keep you from having to 'reinvent the wheel' every time an issue, question, or dispute arises. While it may take a

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

little bit of time to properly develop and implement an employee handbook, once the solid foundation is created, the handbook provides a means of reference for both the employer and the employee to consult when these issues do occur.

When employees hav

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

e documentation to which they can refer that answers most of their basic questions pertaining to their work environment, they do not have to turn to other staff or management to answer these questions for them. The answers are already spelled out in the

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

mployee handbook in a clear and concise manner.

If an employee's child becomes ill, he or she may want to know what family medical leave is available to them. Perhaps an employee’s spouse has to travel out of state for some reason and the employee wants

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

to go along. He or she would need to know what the vacation time policy is and whether he or she is eligible to take the time off to make the trip. Sometimes, it can be a simple question like, "Do employees get to take breaks during the day?" or a quest

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ion as complex as, "My supervisor said he would not promote me because I am a woman, and he wants a man in that position. Isn't that discrimination?"

When an employee does ask a supervisor or human resources person for more information, the supervisor o

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

r HR staff can either refer the employee to the handbook, or find the answer quickly and easily in the handbook themselves. Smaller issues like what time the work day starts, where the break rooms are located, and what the company policy is on personal t

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

elephone calls during work hours can be addressed almost completely through an employee handbook.

Other issues, such as discrimination and legality cannot be fully addressed in an employee handbook. For those larger issues, though, an employee handbook

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

an communicate the company policy on those issues and provide information on where employees should turn should they require additional action on an issue.

When a company’s employees have a well written, properly formatted, and thoroughly developed empl

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

oyee handbook, that handbook provides them with a first point of contact for answering their questions, and then gives them the necessary steps to take should the handbook not address those issues in depth. Because of this, managers, owners, human resour

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ces staff, and department heads will save much time in referring to a well written handbook that addresses common, specific issues, and as we all know, time is money.

So, what does an employee handbook do for your company?

Provides written docu

.

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

mentation of the rules and regulations

Saves time, resources, and money

Provide communication between management and staff

Potentially provides legal protection

Spells out privileges and responsibilities for staff and com

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

pany As you can see, there are many benefits for having an effective employee handbook, but the bottom line is that an employee handbook saves time and money, and in business, your ultimate goal is to be as effective and profitable as possible

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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