Advice You - Business

No one plans on getting let go from a job — many times the reasons are beyond your control. There are specific steps you can take, however, to guard

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

against it ever happening to you by addressing the things that are in your control. Here are some suggestions to help you avoid a potentiall

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

Examples of combination products may in

unhappy situation before you're discharged, and how to get what you’re entitled to if it does happens:

Before

* If the job isn’t right fo

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

you, turn it down. Accepting a mis-matched job will do more harm than good, period. It’s certain to do irreconcilable harm to your long-term career

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

goals. Be honest with yourself—are you really going to be able to adjust to something you don’t want to do or aren’t quite qualified for? Besides, t

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

Combination pro

e company will be able to find several other, very willing people to do the job; they certainly aren't investing their time and money to groom you f

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

or a future situation in a different department or field.

* Find out if the company you’re considering has a formal performance review program. If

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

so, is it set up as a two-way street? If not, consider asking the person who would be your boss if s/he would be willing to work out goals and expec

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

ations for the job so there will be no surprises later.

* Keep written record of your daily activities. Take special note if something goes wrong

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

what happened? could you have corrected it? did you get enough training or direction to be able to avoid it?) and write down if you feel you exceede

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

your boss’ expectations of you. By having this documented, you’re prepared to debate if your performance is ever called into question.

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

Following aspects would a
>

* The person who does the actual firing (be it your boss, someone from human resources, or an outplacement counselor) is there to discuss
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
it, not just do it. Ask questions and get feedback on your performance, the reason behind the action, etc.

* Firing is supposed to be the i
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
-all-else-fails solution to a problem. If it catches you completely off-guard, get as much specific information as you can about what went wrong..
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
and learn from it. Don’t be afraid to ask questions—just keep your cool while doing it.

* If you are planning to use your former employer as a ref
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
rence, be certain that the record reflects an agreed-upon set of circumstances surrounding your dismissal to ensure that you will be correctly repre
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
sented. Come to an agreement with your employer (in writing, if possible) as to exactly what will be said when future potential employers call.

*
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
f the circumstances allow, ask for (unpaid) time to continue to use company resources to assist your job search—such as using a computer and printer
.

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
to prepare your resume or using the phone to set up interviews.

But, most importantly, don't panic. Use your 'release' as an opportunity to make th
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ngs even better in your life. Like many, many people, you might find that your getting fired or laid off was the best thing to happen to your career

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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