Advice Pool - Reference and Education

Kind of a funny title from the CEO of an eLearning company but I know what I'm talking about. As proof, we delivered our first eLearning product in 1989. It was a CBT for learning Digital Equipment Corpora

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

tion’s VAX/VMS operating system. It ran under DOS. In 1995, we delivered our first computer-based course builder and tracking system called Design-a-Course. Twelve years later we are still at it with our

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

Examples of combination products may in

current offering of the same name, albeit completely rewritten and built for the web. So, I have been in this business as long as anyone and seen just about every type of eLearning customer.

There have bee

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

n way too many customers who have purchased an eLearning system from our company to train a group of people who either:
A. Never get around to around to creating the courses. Or,
B. Never get their

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

people to take the courses.

I’m not sure which is harder to believe. Why plunk down good money if you are not going to use the system? I’ll tell you why. It’s the same reason you don’t see training in a

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

Combination pro

lot of categories for, “business type” when you fill out a background sheet for a news or magazine subscription. Training and/or eLearning still doesn’t have the importance it should. Training is always

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

a good thought until something else “more important” bubbles to the top. “I got pulled off the new eLearning course rollout for something really important” is something we’ve frequently heard. I guess trai

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

ning and testing your computer operators to make sure they are doing the nightly backups correctly, which holds all your customer data, isn’t all that important.

It is easy to show someone all the research

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

data about how successful companies are the companies that invest in their employees’ education. And they may appreciate it and buy the training product or service. But too often, after the excitement of t

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

he new purchase, the priorities shift. .

For the determined, cost conscious, and downright responsible users that actually develop and roll out their eLearning courses but never get anyone to take them, th

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

eirs is probably a bigger mistake. They spent the company’s money and used company resources to develop the courses. I have asked customers, “How has the reception been to your new eLearning courses?” I h

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

Following aspects would a

ave gotten answers like:
- I don’t know, I haven’t checked.
- Not everyone has gone through them.
- Not everyone finishes them.

This problem of people not using what they paid for and created

dd to the challenges in developing combination products:

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

does not bode well for the eLearning industry. So, whose fault is it? The students will tell you the courses were not good or not stimulating enough so they lost interest. That could be true. Creating a

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

good, engaging course is a skill. And unfortunately not all companies have instructional designers and great graphics people within their organization. Most organizations just have a need to transfer know

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

ledge to the employees on information critical to their company and job function.

Like all other business issues that affect the employee, it comes down to management. Sorry bosses. Learning in your organ

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

ization, eLearning or any type, is your responsibility. It is part of your job to make sure your staff goes through the courses you took the time to put together. It has to be a job-mandated requirement fr

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

Professional from academic institutions, pharmaceutical industries, health care indust

om the top down. Not completing or not passing the provided courseware should affect the performance review, which should affect the salary. Sounds harsh I know. But your company is only as good as the kn

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

owledge you have inside it. Training needs to be mandated and tracked.

So, if you have purchased an eLearning system and never used it, blame yourself. If you purchased an eLearning system, created the co

.

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

urses, deployed them and your students never used it, blame yourself again. Until learning during the normal course of the business day becomes as fully integrated as checking email in the morning, the grow

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

Companies that provide selfless information through particip

th and, more importantly, the positive and profitable effect eLearning can have on your company will be limited. Worse yet, the potential for a better-equipped, more effective workforce will not be realized

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 - When eLearning Doesn't Work

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