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Main Subject - Be A Great Feedback Facilitator
The feedback facilitator should provide a brief introduction
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
about his background. This is to assure the group about his
; 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
competence and professionalism in directing the session.
The
The
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
feedback facilitator should also have the detailed bio of al
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
l the participants.
It is preferable to have another person
It is preferable to have another person
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
to take down and later transcribe the minutes of the session.
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
It is very important to set out the parameters and the back
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
ground of the discussion.
The duration of the feedback sessi
The duration of the feedback sessi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
on has to be confirmed and the feedback facilitator has to en
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
sure that all ideas have to be recorded within that time peri
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
od.
The facilitator must have good communication skills in n
The facilitator must have good communication skills in n
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
ot allowing any one person to monopolise the feedback sharing
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
.
If the discussion is going to be taped, all feedback contr
If the discussion is going to be taped, all feedback contr
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
ibutors have to be informed first. The reason is that some m
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
embers will want to be anonymous when providing their view po
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
int.
Relevant materials must be given out for feedback contr
Relevant materials must be given out for feedback contr
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
ibutors to review.
The facilitator should ensure that all pa
The facilitator should ensure that all pa
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rticipants be given at least the summary of the entire procee
.
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
dings.
The facilitator should provide his contact or email i
The facilitator should provide his contact or email i
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
f contributors will like to give more ideas after the session
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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