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Employee handbooks are no longer just for large organizations. If you have more people in your company than fingers on your hands then it’s time for an employee handbook.

You might ask, “But why do I need one when lots of companies that are larger than mine

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

don’t have one?” Here are some reasons why owners and CEO’s choose not to introduce an employee handbook into their organization:

· If I put it in writing I’ll actually have to adhere to the policy.
· To me it’s a game. I like to see if I can answer

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

Examples of combination products may in

the same question over and over again with the same answer. Good for the memory.
· I prefer face-to-face interaction, particularly when I’m trying to leave the office for an important client meeting.
· Things have been working out great. Why chang

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

e them now?
· Handbooks are way too corporate.
· I’ve never been sued-- Excuse me, I need to take this call from my attorney.

Has this ever happened to you?

Have you ever worked in an organization that didn’t have an employee handbook? As the ow

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

er or manager, you may have felt relieved to have escaped all of that bureaucracy. That was until someone approached you with a question on company policy that you couldn’t answer. Oh sure, you could have made up a response but you knew your employee would g

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

Combination pro

o back and compare notes with his co-worker. Now if only you could remember what you told the other employee.

Scenarios like this happen every day in organizations that don’t have formalized human resource policies. Having a well-written employee handbook c

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

an help your organization avoid situations like this. But a handbook can do so much more for a company if it’s done right.

Protection

Let’s not kid ourselves. One of the main reasons companies invest in employee handbooks is to protect themselves from futur

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

lawsuits. In today’s litigious environment, you have to be prepared for the worst. If your human resource policies are well documented in a handbook, you will be in a stronger position to defend your company. Don’t wait until you are in the unfortunate situ

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

ation of having your employer/employee relationship go south to test this theory.

Playbook

Sending a manager out to the front lines without an employee handbook is a lot like sending your quarterback onto the playing field without a playbook. The only thing

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

you can bet on is chaos.

Can you really expect your managers or team members to play by the rules if you don’t tell them what they are? Comprehensive employee handbooks ensure that everyone knows the rules of the game before they go into the field.

Setting

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

Expectations

There is a lot of talk about ethics lately and with good reason. What better place to reinforce your code of ethics then in your employee handbook. To avoid becoming tomorrows Tyco, place your code of conduct front and center.

Performance exp

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

Following aspects would a

ectations are vital to the success of any organization. Use this platform to provide a brief overview of how your organization rewards and recognizes excellent performance.

Tooting your horn

We can’t tell you how many times we hear from our clients that em

dd to the challenges in developing combination products:

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

ployees don’t appreciate everything they do for them. We respond by asking our clients if they think their employees even know what’s being provided for them. The response is often a shrugging of the shoulders. We then ask our clients to explain their employ

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

ee benefits to us as if we were one of their employees. Too often they are unable to do so. We then point out that if they are unable to do this what makes them think their managers should be able to do this.

Employee handbooks are a great way to communicat

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

the benefits of working for your firm. You don’t have to go into extensive details regarding all of your benefit plans, but it does make sense to remind employees you have their welfare in mind. After all, if you don’t toot your own horn, who will?

Borrower

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

beware

When it comes to employee handbooks, one size does not fit all. Think twice before making a few changes to a friend’s “borrowed” handbook and calling it your own. The tone of the handbook may be appropriate for a transportation company but is it real

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly suitable for your financial services organization?

Keep in mind that the integrity of a “borrowed” document is questionable since you have no idea who originally wrote the handbook and if it is in compliance.

As tempting as it may be, avoid downloading h

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

ndbooks from the Internet. Yes, the handbook may be fine for a company based in California, but may not be appropriate for a multi-state employer like you. You don’t want to find out the hard way that you are giving out a document that is inappropriate for th

.

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

e state(s) in which you operate.

So, if you are still one of those doubters that thinks employee handbooks are just for big business consider purchasing a tape recorder so you can remember your answers to the questions you are most likely to hear over and ov

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

Companies that provide selfless information through particip

er again. “Do we get Martin Luther King Day off?” “When am I eligible for three weeks of vacation?” “How much maternity leave am I entitled to and what will happen to all of my benefits while on leave?”

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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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We talk about tax freedom day - the day of the year in which the ‘average’ person ceases to work for the British Government and starts to work for him or herself. Modern consumerism is brand brainwashed. People - buy an item because of its brand, when a lower cost one would give the same or better value. - buy from a higher cost channel, where a lower priced one would give the same or better service at a lower price. - buy a higher spec and therefore more expensive article than is needed for the job.

As if interviewing isn't enough to make you nervous, now the hiring authority wants to do it over lunch. Now you have to focus on your interviewing skills AND your table manners! Here's how to balance them both, what's okay and what's not, and how not to embarrass yourself.

It is important to prepare thoroughly for your telephone interview. Begin by studying the job description and the candidate profile. This will enable you to identify the company's particular needs and demonstrate that you possess the skills required to meet them.

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