Advice Pool - Reference and Education

How to initiate a distance education course? Once you’ve decided it would be a good idea to improve your knowledge or qualifications in a particular area,

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

that’s the question facing you if you’ve never pursued one before. Here are nine things to consider:

1. Have a really good think about what you want to ach

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

Examples of combination products may in

ieve. It may sound obvious, but there might be a temptation to pick a course you don’t really need. If, for example, you just want to visit Shanghai because you s

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

w the skyline in Mission Impossible 3, you might decide you need lessons in Chinese. But do you need Mandarin or Cantonese? Do you want to know a set of traveler’s phrases

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

(enough to ask directions, order meals and go shopping) or do you want something a little deeper? The answers will determine what courses you should look at.

2. Find t

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

Combination pro

he program you need to follow. Where to look for your distance education course? Online is an obvious contender. Magazines devoted to the subject you’re intereste

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

in are another. Such courses will appear in the classified advertisement section, or, if they’re really popular, somewhere among the editorial. They’ll usually be s

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

mallish box ads (though not necessarily: Linguaphone have been known to take out much larger display adverts)

3. Ask yourself if accredited distance learning programs <

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

/strong>are what you should be considering. Accreditation may be important, depending on what you’re setting out to achieve.

4. Consider how you’ll plan and

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

manage an e-learning program or correspondence course. You will be making a commitment of time and money, and on top of that, you’ll be putting in some work. If y

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

ou’re following an e-learning program, will you have access to a computer when you need it? These things will need some thought on your part.

5. Arrange the money

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

Following aspects would a

. You may have to arrange a loan via your bank, or, if the course is a long and expensive one (and depending on your status), a student loan.

6. Arrange the ti

dd to the challenges in developing combination products:

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

e. YOu can't just decide you’ll lock yourself away for two hours a week and study: if other people share your life, they'll probably want to impinge on your time.

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

Family members in your immediate household will need warning.

7. Approach your boss if the course is work-related. If you’re studying to improve your wo

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

rk prospects, let your boss know and ask if there’s any chance of help with the costs, some free time at work to study (a couple of hours a week, say), or perhaps a little

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

leeway in your attendance if you need to be elsewhere for exams and the like (you’ll make the time up later, obviously)

8. Take the plunge! Sign up for t

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

Professional from academic institutions, pharmaceutical industries, health care indust

hat course!

9. Have some counter-measure in place for when enthusiasm dips. No article on how to initiate a distance learning course would be complete without

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

mentioning that after about four weeks of hard work, you’ll experience the occasional dip in enthusiasm. It’s important to have some means of to keeping motivated. A

.

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

good trick is to write out your goals (see point 1 above). Next to each goal, write why it's important to achieve it. Then, when you feel enthusiasm flagging, get out your list

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

Companies that provide selfless information through particip

and remind yourself why you're doing this.

And there you have it: nine tips to get you off to a flying start in your distance-learning program. Good luck, and enjoy the journey

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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Advice Pool - How to Initiate a Distance Education Course: a 9 Point Mini-guide

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