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Main Subject - Getting Team Discussions Moving in The Right Direction
Group discussions are where much of the creative work of teams is accomplished. Ideas and problem sol
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
utions from all team members are the desired outputs of group discussions. However, even experienced
; 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
acilitators find leading team discussions a challenge, especially when issues are controversial and e
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
motional.
So as the team facilitator, what do you do?
Though a facilitator's primary objective is t
So as the team facilitator, what do you do?
Though a facilitator's primary objective is t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
help the team come up with its own answers, that's tough when you are part of the team. And one of t
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 hardest things to do is to get the discussion going in the right direction. The team facilitator is
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
the catalyst that starts the ball rolling. You can't leave it up to the team to figure out how to ge
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
started talking.
Here are some tips to help you out so your team begins their discussion on the rig
Here are some tips to help you out so your team begins their discussion on the rig
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ht foot. Try different approaches to see what works for you.
* Before beginning, ensure each team me
* Before beginning, ensure each team me
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
ber can see and hear everyone else.
* Establish a time limit for the discussion.
* Use open-ended q
* Establish a time limit for the discussion.
* Use open-ended q
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
estions to get the ball rolling (e.g., "What has been your experience with…?" - or - "What are your t
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
houghts about…?")
* Ask one question at a time. Have questions in a logical order.
* Give team memb
* Ask one question at a time. Have questions in a logical order.
* Give team memb
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
rs time to think and respond. Pause for at least 15 seconds before giving additional guidance or dire
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
ction.
* If necessary, rephrase your question or provide examples for clarification.
* When team me
* If necessary, rephrase your question or provide examples for clarification.
* When team me
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
bers respond, encourage them to speak to the full group, rather than back to you.
* Try "Brainwritin
* Try "Brainwritin
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
" when the team needs to develop a list of things. For example, ask everyone to jot down 2-3 reasons
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
why a certain problem exists.
* Have team members respond to their neighbors, or work in threes, on
* Have team members respond to their neighbors, or work in threes, on
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
question or issue. Each group should then report its results back to the whole team.
* Ask team mem
* Ask team mem
.
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
bers to make an "educated guess." For example, if the team is trying to implement ways to reduce erro
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
s, ask them to guess the average amount of time a person spends resolving errors made by someone else
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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