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Before we start talking about how to deal with sexual harassment I think it’s important to define exactly what sexual harassment is: Sexual harassment is anything in word or deed that is sexual in nature which makes you uncomfortable.

This can be something as innocuous as a

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

co-worker baldly asking if you got laid over the weekend, to your boss patting you on the posterior as you walk by his/her desk. Sexual harassment can be subtle and it’s not a condition experienced only by women, men experience sexual harassment as well. I suspect that hara

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

Examples of combination products may in

ssment of male workers on the job is just as prevalent as harassment of female workers, men are simply less likely to come forward about it because the idea of a female or even male boss or co-worker sexually harassing a male employee seems ludicrous.

Now that you know what

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

sexual harassment is, what do you do about it if it’s happening to you?

1. Start keeping a written journal of incidents. Write down what happened, what was said to you, and how you chose to deal with it at the time and why. Also put the date and the time of the incident. K

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

eep this journal in a very safe place. If your boss has access to your desk even if it’s locked and he/she is the abuser, it is common for others to get in your desk, keep your harassment journal at home.

2. Tell someone. Start with the Human Resources department. If you wo

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

Combination pro

rk for a small company and there is no HR department or there is no real defined person in charge of HR then go to your boss. If he/she is the harasser then go to that person’s boss. If the your boss is the owner, and there is no HR department, then make a formal complaint t

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

o the Labor Board in your city. Above all do not keep what is happening to yourself. Remember, you have done nothing wrong, and you have the right to work in a safe environment free of sexual harassment.

3. What if you’re retaliated against? Don’t put up with it. Retaliatio

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

n can be very subtle, it might be a one-on-one meeting where your boss or co-worker threatens you and/or your job, or you may find yourself with too little or too much work to do to name a few examples. If this happens, document it in your journal, and go back to whomever yo

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

u spoke to the first time and report the retaliation. Continue to do so for as long as it continues. Don’t let up on the abuser, tell him/her to stop it immediately. Don’t discontinue reporting, even if it appears that no one is listening to you, or even if they tell you to

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

stop. You have the legal right to report the retaliation, any further sexual harassment, and to work in an environment which is not hostile. Remind anyone of that if they attempt to thwart your efforts.

4. Ok, you’ve kept a journal, you’ve reported any further incidents of

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

harassment and retaliation, you’ve repeatedly told the harasser to stop, but nothing is improving. You’ve done everything you can and the workplace has become a nightmare. You wake up in cold sweats from dreams about the situation, you’re having trouble sleeping, eating, and

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

Following aspects would a

you’re suffering from depression and/or extreme anxiety. At this point my advice to you would be to quit and find another job. You may be thinking you need this job. No you don’t. No job is worth being in if you are being sexually harassed and retaliated against. It’s not w

dd to the challenges in developing combination products:

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

orth your health, it’s not worth your time, and it certainly isn’t worth any amount of money.

Quit. It’s that simple. Think you won’t be able to claim unemployment. Not necessarily. If you can prove to the unemployment department that you had no choice but to quit and why t

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

hen you have a chance. Show them your journal, show them a copy of your employment file, (Make sure you get a copy of this prior to quitting. Legally your company must provide you with a complete copy of your file within a specified time period usually 48 hours after the req

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

uest is made.) show them your medical records if you went to doctors and/or therapists in an effort to cope with the situation. Have the person you are working with at the unemployment office call the person you reported the incidents to at the company you worked for, or the

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

Labor Board.

The important thing here is to prove beyond a shadow of a doubt there was no choice but quitting. Of course you also have the option of applying of other jobs while keeping your current job, just be aware you may have to quit prior to finding another job. Don’

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

Professional from academic institutions, pharmaceutical industries, health care indust

t stay if you can safely leave, especially if you have savings or can get help to tide you over until you have a new job.

You’ve quit, you’ve found another job, you’re done right? Wrong. Don’t shred, or throw out your journal, or your employee file, or anything from your do

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

ctor/therapist that helps to prove what happened to you. Keep all of these things, and stay in touch with co-workers at your old job. You never know when someone may file a lawsuit against the company and/or the sexual harasser. It’s also possible a co-worker might quit and

.

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

need your proof to back theirs up so they can get unemployment. The last thing to do is make a second set of everything and put it in a safety deposit box, or give it to a trusted friend or neighbor. This way if your house burns down or some other catastrophe happens you sti

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

Companies that provide selfless information through particip

ll have your proof.

Ultimately the choice is yours as to how to handle sexual harassment, but the important thing to remember is you have the right to a safe and enjoyable work environment. My final words of advice to you are, choose to not be a victim of sexual harassment.

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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