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Digg It - Empower Your Trainees
One of the most memorable quotes that I heard from a trainer came from a man I knew named Rizal:
“As trainees, you are supposed to int
“As trainees, you are supposed to int
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
errupt me if you don’t understand something. You are supposed to ask questions. But you are not to go ahead of where we are in the cl
; 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
ss. All of the sections will be covered in due time.”
As a trainee, I could not have agreed more with Rizal. He made an impact on me
As a trainee, I could not have agreed more with Rizal. He made an impact on me
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
. He was one of the best trainers I have ever known. What made him a great trainer was that he loved his career. (Notice I didn’t say
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ob.) I knew he viewed his classroom as more than just a place to go to work everyday.
As a trainer, what are YOU doing to enhance the
As a trainer, what are YOU doing to enhance the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
spirit of your trainees?
One great tactic that worked for me happened when I was a restaurant manager. When I would train employees,
One great tactic that worked for me happened when I was a restaurant manager. When I would train employees,
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
I would purposely ask them questions that were contradictory. For example, I would ask, “This order is to go, right?” When the traine
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
s answered yes or no, I always asked them why they gave their answer. I wanted them to discover for themselves what should and should
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
not be.
The tactic worked because they learned to rely and trust their own reasoning. Their productivity rose as a result. They were
The tactic worked because they learned to rely and trust their own reasoning. Their productivity rose as a result. They were
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
mpowered to decide what actions needed to be done, and they took the necessary steps that generated results.
Are you letting your trai
Are you letting your trai
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ees know that you are open to ALL questions? Are you asking yourself what you need to do to ask great questions? Are you wondering how
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
you can get your trainees to be comfortable with you so they can get the most of their training?
Here’s Some Steps To Show You How:
Here’s Some Steps To Show You How:
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
. Be up front with your trainees. Let them know that there is NO such thing as a dumb question and that the ONLY stupid questions are
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
the ones not asked.
2. Tell them that they can discuss questions offline if they are not comfortable asking a question in front of oth
2. Tell them that they can discuss questions offline if they are not comfortable asking a question in front of oth
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
rs.
3. If someone asks a great question, acknowledge him or her right away.
4. If a trainee asks a question which emits discontent am
3. If someone asks a great question, acknowledge him or her right away.
4. If a trainee asks a question which emits discontent am
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
ng other trainees, let the classroom know that they are in class to learn and that even the most seemingly silly question could help re
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
inforce answers to other questions. Remind them that no one knows everything, and the moment they stop learning, is the moment they sto
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
growing.
Great trainers are great because they listen. They know that the material they are teaching is new to each person in the roo
Great trainers are great because they listen. They know that the material they are teaching is new to each person in the roo
.
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
m, and they take their time making sure that every person understands it. They have patience and persistence. They are grateful for bei
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
g able to make a difference in the lives of the people they train. Inside of you is the same greatness. Use it to empower your trainees
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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