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Just Other Articles - On My Own Time? What Time?
A friend recently lamented to me that she hadn't had an opportunity yet to take the latest online course offered by her organization. As she put it, "They say it is being ‘offered', but that doesn't mean there is any choic
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
e-we have to take it. The problem is, when?"
In this age of electronic everything, this problem is becoming more and more prevalent. Online learning is often recommended because the courses are available to employees at t
In this age of electronic everything, this problem is becoming more and more prevalent. Online learning is often recommended because the courses are available to employees at t
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
heir desks, working alone and at their own pace, whenever they decide to do so. My friend stated the following drawbacks:
"Difficulty finding time. Like most people, I am very busy in my job. However, if I know, for examp
"Difficulty finding time. Like most people, I am very busy in my job. However, if I know, for examp
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, that a traditional classroom seminar or workshop is to take place next Wednesday from 1 - 4 p.m., I book the time and I go. Fitting it into my work schedule at my "convenience" is more of a challenge. Let's face it-it's
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
never convenient.
"Difficulty focusing. When I am at my desk, it feels foreign to be working on an online course instead of my work. Also, when I am at my desk, other people naturally assume I am doing my job, and they i
"Difficulty focusing. When I am at my desk, it feels foreign to be working on an online course instead of my work. Also, when I am at my desk, other people naturally assume I am doing my job, and they i
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
terrupt me with questions and impromptu meetings as usual.
"Lack of human interaction. The dynamic in a classroom situation is very different from sitting alone at a computer. The opportunity to ask questions of the instr
"Lack of human interaction. The dynamic in a classroom situation is very different from sitting alone at a computer. The opportunity to ask questions of the instr
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
uctor and to exchange questions and thoughts with other participants is an important part of a seminar."
Although all three points are legitimate, as a communication specialist I am particularly concerned with the third.
Although all three points are legitimate, as a communication specialist I am particularly concerned with the third.
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
t seems to me to crystalize an insidious change in society at large, and in business life in particular: loss of inter-personal communication.
I am mesmerized when I watch children and young adults work their way through
I am mesmerized when I watch children and young adults work their way through
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
complex computer programs and surf the Net as though it were the most natural thing in the world-of course for them, it is. They are acquiring naturally a set of technical skills that their elders had to learn with much mo
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
e difficulty, and this is the benefit. However, in all that time spent interacting solely with a computer, what is sacrificed is the development of the social skills that are so critical in the working world.
Great emphas
Great emphas
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is is placed today on teamwork, yet much of the training we expect people to carry out is solitary. Could the training methodology actually be working against other teambuilding efforts?
Obviously, e-learning is here to s
Obviously, e-learning is here to s
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
tay, and far be it from me to speak against progress. I do, however, believe the need for human interaction is built into our very being, and we ignore it at our peril.
The challenge lies in taking advantage of e-learning
The challenge lies in taking advantage of e-learning
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
while at the same time making up for the social element it takes away. Here are three steps to consider.
1. Have a team meeting before the course begins, including an introduction to the features of the course and discus
1. Have a team meeting before the course begins, including an introduction to the features of the course and discus
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
sion of how it will benefit the team. The team sets a specific time for all members to work on the course at once, even if lessons are restricted to an hour or two at a time. A brief discussion could be held by telephone c
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
nference after each lesson, offering an opportunity for airing of any problems or misunderstandings, and the type of group input that often occurs naturally in a classroom setting.
2. Where practical, people should use co
2. Where practical, people should use co
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
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
mputers away from their own desks. Training room facilities are the best, but if these are not available, why not have people swap computer stations while they work on the course? This reduces interruptions, and also takes
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
learners away from the setting where they are normally focused on their day-to-day work. Both of these factors are conducive to learning.
3. On completion of a particular course, team or departmental meetings can be held
3. On completion of a particular course, team or departmental meetings can be held
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to discuss how the new learning can be put into action. When courses are mandatory, people too often feel they are simply working towards a certificate, and they need to have an opportunity to see the practical benefits of
.
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
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
what they learn.
My own workshops often elicit such comments as "It was fun!" That is the result of the classroom dynamic and my own strong belief that adults learn most effectively when they are enjoying the process. Yes
My own workshops often elicit such comments as "It was fun!" That is the result of the classroom dynamic and my own strong belief that adults learn most effectively when they are enjoying the process. Yes
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
, I work to make my workshops fun, because that means they will be more effective. Designers of e-learning programs could increase the value of their products by remembering that learners are not e-beings, but human beings
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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