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Digg It - Principles That Lead to Successful Meetings
These four principles provide a foundation for leading effective meetings.
1) Everyone has valuable ideas.
1) Everyone has valuable ideas.
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
Your job as leader in a meeting to put people to work. And this includes everyone. If you plan to invite som
; 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
one without expecting contributions, leave that person out. Spectators cost money and slow the meeting proce
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s.
> Example: Open a meeting by telling the attendees, "I asked you to come to this meeting because I need
> Example: Open a meeting by telling the attendees, "I asked you to come to this meeting because I need
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
our help." Then use equitable participation to collect ideas from everyone.
2) People rise (or drop) to mee
2) People rise (or drop) to mee
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
positive expectations. Savvy leaders tell people that they're smart, clever, or creative because that makes
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
them perform like people who are smart, clever, or creative. Certainly, the opposite is true: those who insu
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
t people stifle extraordinary performance.
Example: Tell the attendees that you expect them to accomplish y
Example: Tell the attendees that you expect them to accomplish y
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ur goal for the meeting by saying, "We have a tough problem here and I expect that you can find an solution
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
or it." Then help them meet your expectations.
3) Respect motivates people. All of us want to be treated wi
3) Respect motivates people. All of us want to be treated wi
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
h respect. It makes us feel strong, powerful, and capable. And this helps make a meeting more productive. On
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
the other hand, disrespect damages productivity by causing resentment, withdrawal, and retaliation.
Exampl
Exampl
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 someone makes an odd remark during a meeting, react with optimistic surprise by saying, "What a novel i
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
ea." or "How interesting." Then explore for applications ("How can we use this idea?") or understanding ("Te
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
l me more about how this would work").
4) Win-win goals produce more. People will work hard to accomplish s
4) Win-win goals produce more. People will work hard to accomplish s
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
mething that represents a benefit. In contrast, they will resist working on something that could cause them
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
arm. This requires seeking both-and solutions by a consensus-driven process.
Example: When working on a con
Example: When working on a con
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
roversial issue with conflicting proposals, seek solutions that accommodate everyone’s needs. This requires
.
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
areful and candid dialogue to understand what these needs are. Then, the group will have find a result that
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
ncludes the essential elements of all of the needs (i.e., a both-and result, instead of an either-or result)
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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