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You have lived the life: Adrenalin-charged meetings, exhilarating presentations and major business deals signed on the dotted line – but also senseless re-briefings, over-cautious clients and busine

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

ss partners, bitter managers and frustrated colleagues. And let's not even talk about the overtime.

It was great while it lasted (most of the time, anyway), but now the spark is gone. You know it i

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

Examples of combination products may in

time for YOU to finally hop off the hamster wheel and start something new!

Deciding to make a major change in your career in seldom easy. In these economically instable times most people are consc

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

iously putting their life’s dreams on the back burner in exchange for the steady income they receive at the end of each pay period.

Some people, however, still reach that point in their career wher

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

they simply know they need to do something different. Although this realization can be extremely liberating, it seldom comes without some sense of apprehension, confusion and uncertainty.

If you a

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

Combination pro

e in the midst of this crucial decision-making process, here are some of the essential questions you should ask yourself as you begin to map out what YOU want your new career to look like:

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

Passion: What are you passionate about? Ask yourself what specific career move would enable you to apply your talents, skills, and abilities in a way that would not only positively

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

hallenge you, but also allow you to add maximum value to whatever professional situation you are in.

Sea change or career change: How deep does your dissatisfaction run? Do

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

you really need to change your entire career - or just your job? Ask yourself whether you can possibly re-invent yourself within your current company or if you need a whole new backdrop for the next

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

stage in your career.

What is your measuring stick for success: Forgot about what others expect of you! What do YOU need to feel your work is both meaningful and rewarding?

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

sk yourself what symbolizes success for you - and what it will take in your new career to make you feel as though you have achieved those goals.

How much time do you have to succeed<

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

Following aspects would a

/strong>: What is a reasonable amount of time to allow yourself to reach that milestone that let’s you know you’ve made it? Develop a timeline, so you know how long you have to prove yourself. To yo

dd to the challenges in developing combination products:

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

rself.
Bankroll: How are you going to continue paying the bills? Ask yourself if you will need an additional source of income during your transition period. If so, where wil

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

l is come from? Don’t forget: Plan B.
Kith & Kin: Will your friends and family rally around and cheer you on as you work towards your new goals? Or will they be doubtful, ma

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

be even try to dissuade you from doing anything (they feel is) too radical? Ask yourself how much support you can realistically expect from the people around you - and how that may influence your pe

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

serverance.
Contacts? Contacts! Who do you know who has been in a similar position? Who do you know who has knowledge about the field you would like to enter? Who do you kno

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

Professional from academic institutions, pharmaceutical industries, health care indust

w who can refer you to a prospective employer - or future client? Ask yourself what resources you have on your personal and professional contact list.
Stepping out on faith:

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

Whether at the end of your decision-making process you decide to apply for a new job or begin an entirely new career, there are no guarantees. Ask yourself how firm you are in your conviction to sta

.

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

y the course - then go for it!Whether you decide to take on this major transition in your life with the help of family or friends, or with the support of an experienced career coach, there

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

Companies that provide selfless information through particip

is nothing more exhilarating than that first deep breath you take once you have made your decision, acted upon it - and begin to see how the new life you have created for yourself proceeds to unfold

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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