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What is a hostile work environment? Here is a good definition from East Carolina University’s Office of Equal Opportunity and Equity websit

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

e:

[a hostile work environment is…] one that both a reasonable person would find hostile or abusive and one that a particular person who is

; 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 object of the harassment perceives to be hostile or abusive. Hostile work environment is determined by looking at all of the circumstan

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

ces, including the frequency of the allegedly harassing conduct, its severity, whether it is physically threatening or humiliating, and whet

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

her it unreasonably interferes with an employee’s work performance

Whether you plan on leaving your employer or staying put, any type of se

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

Combination pro

vere hostility (conflict, opposition, or resistance) that interferes with your job performance should be handled in a professional manner.

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

Doing so will only help you in the future, so avoid bad-mouthing the offender or your employer. You never know, how your paths will cross a

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

gain. “Keep your words sweet...in case you have to eat them.”

Here are some tips for coping in a hostile workplace:

Keep in mind why you

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

are at the job.

Why are you working at that particular company? Whatever the reason, let the objective you want to achieve give you the mot

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

ivation to survive each day.

Focus on your own responses.

As difficult as the situation may be, learn to control how you respond to it. T

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

ry to cope internally. Prayer can be effective in “getting yourself together” and keeping your composure.

Carefully choose who you associat

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

Following aspects would a

e with.

Learn what not to say and who not to trust in future. Avoid discussing your private life while at work (with others and on private

dd to the challenges in developing combination products:

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

phone conversations). This reduces your being a target for gossip.

Find another opportunity.

If the situation does not improve to your sat

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

isfaction, and you have exhausted all options, look out for yourself and leave.

Tips for Management & Supervisory Employees

1. Identify t

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

he stressful relationship between the individual or group and the work setting. Strategies might include changes in worker assignment to pro

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

duce a better person-environment fit.

2. Make modifications to the working conditions so that they are less stressful and more conducive to

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

Professional from academic institutions, pharmaceutical industries, health care indust

effective coping and job performance. Example: changing organizational decision-making processes to include employees.

3. Help individuals

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

adapt by teaching them better coping strategies for conditions that are impossible or difficult to change. Bringing in counseling services

.

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

for employees, or encouraging employees to use the company’s Employee Assistance Programs.

Web Resources
http://www.workplacefairness.

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

Companies that provide selfless information through particip

org/harassment
http://www.CareerCookie.com

Print Resource
The Ten Commandments of Working in a Hostile Environment by: T.D. Jakes

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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Too many people are in careers that are not enjoyable. This affects relationships at home and many other areas of life. Are you ready for a change? This article discusses your choices and likely outcomes.

Do your co-workers share your views on time and how best to use it? If not, don't let your differences sabotage your projects! To learn 5 ways to use differences in time philosophies to your advantage, read on.

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