Advice Pool - Reference and Education

All the hype surrounding eLearning has only succeeded in creating unnecessary confusion. So, what is eLearning

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

really? Simply put, eLearning is the delivery of content via all electronic media, including the Internet, in

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

Examples of combination products may in

ranets, extranets, satellite broadcast, audio/video tape, interactive TV, and CD-ROM. Yet, eLearning is define

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

more narrowly than distance learning, which would include text-based learning and courses conducted via writt

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

n correspondence. The term eLearning is used synonymously with technology-based learning. Terms like eLearning

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

Combination pro

technology-based learning, and web-based learning are defined and used differently by different organizations

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

and user groups. Moreover, use of these terms is constantly changing, as the world of eLearning evolves.

Whil

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

eLearning's roots are based in traditional instructor-led training (ILT) and computer-based training (CBT), t

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

e eye of eLearning is on the future -- evolving to create training options that didn't even exist a few years

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

go. ELearning offers:

Best-of-both-worlds solutions: Effective eLearning that combines the p

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

oven training methods of traditional ILT with the rich resources of CBT to create an engaging, online training

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

Following aspects would a

solution.

Online flexibility: Train and retain the mission-critical information you need --

dd to the challenges in developing combination products:

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

whenever and wherever you need it -- without ever having to leave the office or people who need you.

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

eal-world interactivity: Engaging hands-on lab simulations allow students to test their skills in a p

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

rfectly simulated environment, increasing the likelihood they'll remember what they've learned and be able to

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

pply it later on the job.

Personalized learning: Through online pre-assessment tests that me

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

Professional from academic institutions, pharmaceutical industries, health care indust

sure knowledge and skill levels, each learner's experience is personalized to ensure you receive only the info

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

mation you need.

There are thousands of eLearning courses available on the web, both free and for sale. You c

.

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

n also have courses customized or created specifically for your company. The different options available for y

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

Companies that provide selfless information through particip

ur personal or company's growth are enormous. Take advantage of all the offerings available at your fingertips

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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In the first of this series of articles Desmond Guilfoyle explores some of the fundamentals of effective media performance.

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