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Digg It - Ten Ways to Maximize the Impact of Training
Training your staff is an essential investment in today’s changing and competitive environment. But just sending staff to attend training programs i
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
s not enough. You should maximize the impact of your investment by following these key guidelines before, during and after the training.
Before the
Before the
; 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
training program:
1. Review with staff why they were selected for the program and discuss anticipated benefits for the organization. This shifts t
1. Review with staff why they were selected for the program and discuss anticipated benefits for the organization. This shifts t
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
heir perspective from purely personal, ‘I am going to attend a training’, to personal and organizational, ‘The organization is making an investment
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
o I can attend a training. The purpose of this investment is to help me upgrade my skills so that my team and our organization becomes more effectiv
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e.’
2. Ask participants to talk about how they might benefit from the program. Where do they see opportunities for improvement in their own skills
2. Ask participants to talk about how they might benefit from the program. Where do they see opportunities for improvement in their own skills
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
and/or behavior?
3. Discuss and obtain agreement from your staff for their punctuality, attendance and active participation in the training program
3. Discuss and obtain agreement from your staff for their punctuality, attendance and active participation in the training program
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
.
4. Redistribute participants’ workloads so they don’t return to a mountain of pending matters. This helps participants keep their minds focused o
4. Redistribute participants’ workloads so they don’t return to a mountain of pending matters. This helps participants keep their minds focused o
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
the course.
5. If sending more than one participant, create a ‘buddy system’ before they go. Buddies should work together to ensure each participa
5. If sending more than one participant, create a ‘buddy system’ before they go. Buddies should work together to ensure each participa
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
tes fully and gains maximum value from the training.
During the training program:
6. If the course is more than one day, have participants brief t
During the training program:
6. If the course is more than one day, have participants brief t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
heir managers as the course progresses. This can be done in a short face-to-face meeting, a telephone call at the end of the day, or in a summary by
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
e-mail.
Participants should identify what material was covered during the day, what new learning occurred and what value they see in applying this
Participants should identify what material was covered during the day, what new learning occurred and what value they see in applying this
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
learning back at work.
7. Discuss any ambiguities or uncertainties from the course material that may arise. Help participants identify key learning
7. Discuss any ambiguities or uncertainties from the course material that may arise. Help participants identify key learning
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
points and examples of their application on the job. If needed, help write clarifying questions for participants to take back to the course instruc
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
tor on the following day.
8. If there are interim assignments to complete, engage others who are not attending the course in discussions and delibe
8. If there are interim assignments to complete, engage others who are not attending the course in discussions and delibe
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
rations. This brings the learning experience back into the office, building an internal support network during and after the training.
After the tr
After the tr
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
ining program:
9. Meet with participants to review:
What were the most valuable lessons from this program?
What will you now do differently? In w
9. Meet with participants to review:
What were the most valuable lessons from this program?
What will you now do differently? In w
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
hich situations?
When will you begin or try this new approach?
What suggestions do you have to improve or customize the course?
Who else do you b
When will you begin or try this new approach?
What suggestions do you have to improve or customize the course?
Who else do you b
.
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
elieve should attend this particular training program?
10. Discuss organizational improvements that could be implemented based on the participants’
10. Discuss organizational improvements that could be implemented based on the participants’
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
new learning. Be willing to try new suggestions on a trial basis with the course participants closely involved in implementing and tracking results
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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