Main Subject - Business

Thinking about changing your career... but worried that you may not have the background or qualifications to make the change?

In some cases, you're right to be worried. Some careers do require you

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

to possess specific qualifications and experience.

However... it could be that your concern isn't warranted at all.

Actually, you may have "credentialitis" - you think you need some kind of creden

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

Examples of combination products may in

ial to qualify you for a promotion, new position or career change, when you actually have all the skills, talent and knowledge necessary.

Funny, really.

I always considered qualifications and cr

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

dentials to be short-hand for skills and knowledge... but not the only "short-hand" and not necessarily indicative of the most valuable skills and knowledge.

For example, what if you're an entrepre

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

eur who left high school before graduating, launched a super-successful business which you ended up selling, and now want to be the marketing manager of a large, established company?

If you suffere

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

Combination pro

from credentialitis you may believe that you aren't qualified to become that marketing manager.

So much so that you seriously consider going to business school and enrolling in a marketing program

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

. Now, you may well benefit a lot from doing this... but was it really necessary to study for one or two years to get that marketing job? Did you really lack the critical skills for the role?

Co

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

ldn't you present yourself as someone with unequaled business experience, skills and knowledge - someone who has built and sold a company, as opposed to someone with theoretical knowledge acquired f

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

om a business school?

Now, of course, in some cases you will need to study and get a particular qualification to make a career change - for instance, if you want to become a dentist or mechanical e

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

gineer.

But in other cases, you probably have the fundamental knowledge and skills required for the new job...

and what you don't know can either be picked up relatively quickly on the job or isn'

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

all that important.

I know, I know - you may be confident in your own abilities, but how do you convince a potential employer who wants to see that certificate, diploma or degree? After all, it

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

Following aspects would a

seems our entire society has credentialitis.

But if we agree that this societal credentialitis is unnecessary and damaging (in the sense that skilled, knowledgeable and talented people miss out o

dd to the challenges in developing combination products:

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

jobs and careers to which they're suited) then it's up to you and I to change things.

What this means is - get confident! Know and feel - and communicate - that you have the skills and abilities f

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

r the new career.

But if you still wonder whether some kind of formal education might be necessary, answer the following:

Would the course or program genuinely teach you something new... or would

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

t give you a piece of paper to prove what you already know?

Really, if you manage to overcome your credentialitis you'll not save a lot of money, time and energy on unnecessary studies, but you'll

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

lso become a happier, more fulfilled person.

If you are challenged over your lack of credentials you can "reframe" your background... so that it's obvious that this has equipped you with the ideal

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

Professional from academic institutions, pharmaceutical industries, health care indust

background for the new job.

I, for example, was once questioned over my lack of an MBA. I explained that my background as an advertising copywriter, marketing manager, commercial lawyer and busin

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

ss owner had given me a real-world MBA.

Of course, you'll find some people who just won't "buy it" - they obviously have credentialitis themselves. In this case, it's up to you whether it's worth

.

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

your while trying to convince them... or whether you're better off trying to work with people who aren't so hung up on qualifications and recognize true ability.

Also, try to look beyond creden

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

Companies that provide selfless information through particip

ials when it's you who is doing the hiring. An individual who has years of hands-on experience may well be just as, if not more, qualified than someone with a specific certificate, diploma or degree

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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If you are an entrepreneur with a small food or beverage company looking to take it to the next level, this article should be of particular interest to you. Your natural inclination may be to seek venture capital or private equity to fund your growth, but that might not be the best path for you to take.

Okay so I do a lot of research; have traveled afar and obviously I have something to say. Ah; “Rants from Lance” indeed. Yes in fact it is over do but it is time; It is Soap Box time; I Read an interesting article today about the fact that 80% of all penalties for employment withholding costs were fined to small businesses with under ten employees.

In all advertising, as all its advertised items – one motto stands with best results for effect and continuity - HONESTY IS THE BEST POLICY!

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