Advice You - Internet and Businesses Online

One of the most frequent questions we get is "what does it take to put my course online?"

In an effort to give you more information, this is the first in a series of articles on just that topi

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

c. In this article, we’ll look at the three components that need to be in place before you start to put your content online.

Audience

Do you have an audience for your content? Creating an o

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

Examples of combination products may in

nline course takes your time and effort. You want to ensure that there are enough people who want to see your content to make it worth your while.

If you’re creating a course you should be awa

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

e of who your audience is and how to reach them. For example, will you tell them about your course through an email newsletter? A link from your website? Or a listing in your company or college co

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

urse catalog?

Regardless of your approach you want to have a plan in place before you start creating your course. Ask some of your potential audience members if they would like to see the cour

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

Combination pro

e online? Would they take it if it were offered online? What would they pay to take it in an online setting?

Content

Once you’re assured that you’ll have an audience, you need to look at yo

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

ur content. Your content may be a seminar you give on a regular basis, a college course you teach for credit or non-credit, a series of articles you’ve written, or a new way of performing a proces

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

that you want to share with others. Regardless of the actual information you have, it can be converted into an online course! But you’ll need to ask yourself some questions about your content.

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

1. Do you own the rights to the content? If you’ve been teaching it in a face-to-face environment you may have accumulated some materials that clearly are not yours. Others may have been incorpor

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

ted into your course and you’re uncertain of their origin. When you post content on the Internet, you must have clear ownership of the materials or written permission to use them online. Even 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 have permission to use them in your course, there is a difference in the permissions needed to use them in a single classroom and the permissions needed for online viewing.

2. How is the co

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

Following aspects would a

ntent organized? If you have already organized it for sharing with others, then you probably have the major topics and subtopics outlined. If not, start right now to decide on the major topics and

dd to the challenges in developing combination products:

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

the supporting information under each topic. How many topics should you have? That depends on your content. If you are creating an online version of a six-hour workshop, you’ll probably have at le

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

ast 6-10 major topics. A "topic" should not take longer than an hour to complete online.

3. What format is the content in now? If you are using hand-written notes, copies of cartoons, some tran

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

parencies, and a few other props, you’ll need to begin immediately to convert the content to electronic files. You can use word processing files, spreadsheets, slide shows, java applets, etc. Almo

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

st an unlimited number of file types are supported in most authoring environments. The important thing is to remember that ALL of the content will need to be in an electronic format.

Expertise

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

Professional from academic institutions, pharmaceutical industries, health care indust

While creating an online course is not technically challenging with a learning management system (we’ll talk about that in the next lesson), it does require that you are able to use an Internet

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

browser, that you can open word processing files, and that you can manage the electronic files you need on your hard drive. Other than that, no additional expertise is required. However, if you 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

e a "techie" you’ll find that you can use HTML files, java applets, and other technical approaches in most learning management systems. They’re very user-friendly!

I hope that’s given you an id

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

Companies that provide selfless information through particip

ea of how to start thinking about putting your content online. When you're ready for the rest of the course, send an email to elearning@techtamers.com

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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