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Advice You - Conducting Successful Training Activities
Whether you are training preschoolers in the classroom or executives in the board room, her
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 are 15 premises you might want to keep in mind the next time you're designing training ac
; 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
tivities.
1. Everybody has the capacity to learn.
2. Everybody learns at his own pace.
3
1. Everybody has the capacity to learn.
2. Everybody learns at his own pace.
3
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
. The trainee learns only when he is ready and is motivated.
4. Training must, therefore,
4. Training must, therefore,
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
get the trainee ready and motivated by satisfying his needs.
5. Training must, therefore,
5. Training must, therefore,
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
begin at the trainee's level of comprehension.
6. Begin with the simple information and pr
6. Begin with the simple information and pr
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
ogress to the complex.
7. Use mutually familiar frames of reference.
8. Make the training
7. Use mutually familiar frames of reference.
8. Make the training
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
meaningful by systematically organizing it.
9. Provide relevant and timely supporting mat
9. Provide relevant and timely supporting mat
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
erials in adequate quantities.
10. Watch for and avoid trainee boredom by using variety in
10. Watch for and avoid trainee boredom by using variety in
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
your activities, materials, and speaking manner.
11. Provide trainees with feedback and r
11. Provide trainees with feedback and r
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
einforcement about their participation.
12. Provide ample time for repetition and practice
12. Provide ample time for repetition and practice
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
.
13. Give trainees the opportunity to adapt the training to new and different situations.
13. Give trainees the opportunity to adapt the training to new and different situations.
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
14. Reassure the trainee and use his experiences.
15. Make the training practical by dev
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
eloping an agenda that's practical.
Follow these premises and you'll find that your activi
Follow these premises and you'll find that your activi
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
ties will become increasingly successful.
Remember: When you maximize your potentia
Remember: When you maximize your potentia
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
l, everyone wins. When you don't, we all lose.
© Etienne A. Gibbs, MSW
PERMISSI
© Etienne A. Gibbs, MSW
PERMISSI
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
ON TO REPUBLISH: This article may be republished in ezines, newsletters, and on web sit
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
es provided attribution is provided to the author, and it appears with the included copyrig
.
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
ht, resource box and live web site link. Email notice of intent to publish is appreciated b
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
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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