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Useful Advices - Learning Guides a Great Addition to Procedures Manuals
Introduction
Learning guides are a very useful medium for delivering flexible delivery when the topic and circumstances are conducive to it. According to Bruhn and Guthrie (1994), a Learning Guide is a 'structured booklet designed to direct the learner through a series of learning activities and t
Learning guides are a very useful medium for delivering flexible delivery when the topic and circumstances are conducive to it. According to Bruhn and Guthrie (1994), a Learning Guide is a 'structured booklet designed to direct the learner through a series of learning activities and t
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
o a range of resources to achieve specified competencies or learning outcomes".
A learning guide is not a 'how to' manual like manuals that accompany television sets, microwaves and computers etc, but they may be used in conjunction with them. The key focus of learning guides (hereafter 'guides') is that
A learning guide is not a 'how to' manual like manuals that accompany television sets, microwaves and computers etc, but they may be used in conjunction with them. The key focus of learning guides (hereafter 'guides') is that
; 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
they guide users through a structured learning experience. Manuals don't do that, they simply provide a number of activities users can follow to get certain outcomes. An example will highlight the difference.
Example:
On one occasion I used guides to cover a half dozen or so small topics that wer
Example:
On one occasion I used guides to cover a half dozen or so small topics that wer
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
important, but which did not warrant group training sessions (I later redeveloped them as computer based instruction modules delivered online). This was in an organisation that had six offices spread throughout the Northern Territory (Australia), two of which were remote. Costs for training delivery were
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
often very high due to the need for travel, therefore, it was desirable to find alternative delivery modes in order to keep costs.
One of the topics my guides covered for example, was titled "Using Delegations" and consisted of only 16 pages.
Note: For those not familiar with delegations, they
One of the topics my guides covered for example, was titled "Using Delegations" and consisted of only 16 pages.
Note: For those not familiar with delegations, they
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
refer to the acts or omissions a person holding a specific job can do or not do eg, approve leave of absence for a staff member, buy goods and services valued up to $30,000, or terminate an employee's service. People exercising a delegation are called delegates. If you don't hold delegation, then you can'
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
lawfully execute a task.
It was important that delegates knew what they were, or weren't authorised to do. Non-delegates had to know who had delegation to carry out the tasks required. My short learning guide included the following parts:
It was important that delegates knew what they were, or weren't authorised to do. Non-delegates had to know who had delegation to carry out the tasks required. My short learning guide included the following parts:
- A Module Overview setting out the purpose, deliver
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
strategy, learning outcomes, how to achieve the outcomes, resources required, and details about how the topic was to be assessed
Five learning activities
An assessment questionnaire
A summary and review page
An attached answers guide for the intermediate assessment topics (self as
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
essment)
Learning activity one detailed the framework in which delegations exist ie, Constitutional and other legislative matters that allow delegation. There were two activities at the end of Learning Activity One. The first required learners to obtain a copy of an Act of Parliament and study se
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
eral sections (about delegation). The second required people to read a description, find the section of an Act that related to that description and write in the answers on a blank table. (This was my way of making sure people actually read specific sections).
Learning activities two through five all had
Learning activities two through five all had
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
similar process of getting learners to do something followed by a short self-assessment.
Finally, learners were expected to answer 10 "fill in the answer" questions and provide answers for two small case studies involving real life delegations activities. The former required learners to refer to the org
Finally, learners were expected to answer 10 "fill in the answer" questions and provide answers for two small case studies involving real life delegations activities. The former required learners to refer to the org
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
nisation's Delegations Manual and record which delegation (if any) fitted a specific circumstance. When learners completed the assessment questionnaire, they would fax it to the Training Department. One of my people would mark it and provide feedback about the result.
Each learning activity covered a sep
Each learning activity covered a sep
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
rate, small part of the whole topic. (People learn in small bits). I provided feedback through self-assessment and faxed assessment. (People need feedback). Topics were logically sequenced. (People need to work from general concepts to specific concepts). Learners used the manuals and legislation that act
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
ally applied to them in their everyday jobs. (Adult learners particularly want to learn 'real', practical solutions, not deal with fiction).
You'll understand now how the structure in a learning guide and the use of instructional design principles makes them different from a standard operating manual. On
You'll understand now how the structure in a learning guide and the use of instructional design principles makes them different from a standard operating manual. On
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
key advantage of learning guides is that you don't have to incorporate documents that are elsewhere available ... all you do is reference them. If they change, it's not that difficult to update your learning guide.
Conclusion
Just as there is a time and place for everything else, there is a time
Conclusion
Just as there is a time and place for everything else, there is a time
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
and place for learning guides. If you use them on the right occasion AND your target audience is conducive to self-directed learning, they can be an excellent solution to some of your training delivery challenges. Design lead time is relatively short and they can be effectively delivered using electronic
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
r printed media; they can be used for just-in-time training.
However, like any training intervention, they need to be 'designed' using appropriate instructional design principles. That means that it is a specialist job to produce quality guides, not the role of a person who is a 'presenter' or 'facilitat
However, like any training intervention, they need to be 'designed' using appropriate instructional design principles. That means that it is a specialist job to produce quality guides, not the role of a person who is a 'presenter' or 'facilitat
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r' having completed a two or three day course in workplace training and assessment.
Most of the learning guides I produced were based on Bruhn and Guthrie's work, although I had used other methods during my teaching/training career and read many other texts. For example, Derek Rowntree's book, details o
Most of the learning guides I produced were based on Bruhn and Guthrie's work, although I had used other methods during my teaching/training career and read many other texts. For example, Derek Rowntree's book, details o
.
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
which appear below, also contain excellent advice and information for anyone wanting to learn the art.
When next you need to deliver numbers of small, concise, discrete topics, think about using learning guides to accompany your organisations operational and procedures manuals.
References:
Bruh
When next you need to deliver numbers of small, concise, discrete topics, think about using learning guides to accompany your organisations operational and procedures manuals.
References:
Bruh
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
, P and Guthrie, H (1994), Designing Learning Guides for TAFE and Industry. National Centre for Vocational Education Research Ltd, Victoria.
Rowntree, D (Latest edition), Teaching Through Self-Instruction: How to Develop Open learning Materials. Kogan Page Publishing, New York.
Copyright 2005 Robin Henr
Rowntree, D (Latest edition), Teaching Through Self-Instruction: How to Develop Open learning Materials. Kogan Page Publishing, New York.
Copyright 2005 Robin Henr
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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