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Main Subject - Pre-meeting Information
A large part of what makes a meeting successful occurs in the preparation phase. Although it may vary by committee, department or unit, there are seven key responsibilities expected of chairs or team leaders before a meeting takes place. Each is explained in detail below.
1. Clarify purpose and aims. A
1. Clarify purpose and aims. A
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
clearly stated purpose or aim describes the key decisions that must be made or actions that must occur at the meeting. The purpose of a meeting should be stated at the top of the meeting agenda. Some example purpose statements might look something like:
Share best practices in graduate recruitmen
Share best practices in graduate recruitmen
; 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
and identify opportunities to recruit collaboratively
Identify priority goals for next year
Examine and update admission criteria
Decide how to get feedback from faculty, staff and students
Everything else on the agenda including topics, times, and presenters are the activi
Identify priority goals for next year
Examine and update admission criteria
Decide how to get feedback from faculty, staff and students
Everything else on the agenda including topics, times, and presenters are the activi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ties that, taken together, will accomplish the aims. A weekly or monthly staff meeting may not require meeting aims beyond the agenda items.
2. Create an agenda. An agenda is a framework that guides and supports the meeting. Agendas are like roadmaps, blueprints, flight plans, and recipes. An agenda hel
2. Create an agenda. An agenda is a framework that guides and supports the meeting. Agendas are like roadmaps, blueprints, flight plans, and recipes. An agenda hel
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s focus the group's work toward achieving desired outcomes. Good agenda items provide focus and structure for a meeting. Some example agenda items might look something like:
Report on fall enrollments
Identify members for ad hoc space committee
Generate list of possible solutions
Report on fall enrollments
Identify members for ad hoc space committee
Generate list of possible solutions
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
or the xyz problem with pros and cons of each
3. Schedule the meeting. Scheduling a meeting involves much more than just making a list of attendees. It requires identifying key people who must attend and either finding times that work for them or notifying them of the meeting's time and location. On
3. Schedule the meeting. Scheduling a meeting involves much more than just making a list of attendees. It requires identifying key people who must attend and either finding times that work for them or notifying them of the meeting's time and location. On
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
ce an optimal date and time are agreed upon, a meeting location can be selected. (Choice meeting locations sometimes dictate meeting dates.) Other scheduling activities might include some of the following:
Create a scheduling grid
Create an electronic mailing list at the start
Kee
Create a scheduling grid
Create an electronic mailing list at the start
Kee
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
a sample E-mail handy to use as a double-check
Draft the final meeting notification early on, with date, time and location added later.
4. Post and send out agenda. An agenda should be sent to participants ahead of time to help them prepare to participate. There are legal requirements for po
Draft the final meeting notification early on, with date, time and location added later.
4. Post and send out agenda. An agenda should be sent to participants ahead of time to help them prepare to participate. There are legal requirements for po
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
sting meeting notices.
5. Circulate supporting information. You should always circulate supporting materials to participants in advance of the meeting. However, deciding how much information to send in advance can present a conundrum. Some people won't look at anything prior to the meeting and some will
5. Circulate supporting information. You should always circulate supporting materials to participants in advance of the meeting. However, deciding how much information to send in advance can present a conundrum. Some people won't look at anything prior to the meeting and some will
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
conscientiously read all the supporting information they can.
6. Make room arrangements. Ensure that room arrangements (including refreshments) are made. Room arrangements can make a big difference in how well a meeting goes or doesn't go. Most important is that participants can see and hear each other.
6. Make room arrangements. Ensure that room arrangements (including refreshments) are made. Room arrangements can make a big difference in how well a meeting goes or doesn't go. Most important is that participants can see and hear each other.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
Although a "U" shape arrangement or open square is ideal for smaller groups of 20 or less, it is not usually a good choice for larger groups. The yawning hole in the middle makes communication difficult. A herring bone arrangement of tables is usually better for these larger groups. Room Arrangements for
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
a Successful Meeting An important role for a committee chair or facilitator is to ensure that everyone present has the opportunity to participate in the deliberations. This means being able to see and hear each other. Some room arrangements facilitate communication and interaction more than others. For
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
mall groups, a "U" shape or open square arrangement is ideal - everyone can see everyone else and the shape by itself suggests interaction and equal participation.
Those same shapes, however, can be deadly when groups get over 20 or so. Suddenly the huge empty space in the middle yawns. Each side of the
Those same shapes, however, can be deadly when groups get over 20 or so. Suddenly the huge empty space in the middle yawns. Each side of the
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
"U" or square becomes so long that people are actually quite far from each other, making it difficult to hear and see others. Ironically, the same shape that creates such a warm atmosphere for small groups becomes counter-productive for larger groups For groups over 20, consider a herringbone arrangemen
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
of tables and chairs with 4 or 5 people at each. These arrangements enable people to easily see and interact with others, not only at their own table, but at the tables around them as well. Have as many tables as are required so that no one must sit at an uncomfortable angle to see what is happening at
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
he front. Committee decisions often benefit by some small group discussion before the group as a whole makes a decision. Consider in advance whether separate breakout rooms are needed. If the room is large, participants can spread out by moving their chairs to various corners. If there is not room to spr
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
ead out, the noise level can make it almost impossible for the groups to accomplish their work.
This noise level is particularly uncomfortable for participants with hearing aids. Ironically, the same shape that creates such a warm atmosphere for small groups becomes counter-productive for larger groups.
This noise level is particularly uncomfortable for participants with hearing aids. Ironically, the same shape that creates such a warm atmosphere for small groups becomes counter-productive for larger groups.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Breakout space doesn't necessarily need to be another formal meeting room. In thinking of alternatives, consider having groups go outside to work, weather-permitting. There may be lounge areas or a lobby to which small groups could go for their working session. At one memorable meeting, a small group me
.
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
t in the lounge adjoining the ladies room! The point is to consider ahead of time what kind of space is required for the work to be done.
7. Arrange for a recorder. The recorder takes notes on paper, laptop or on flip charts. Meeting notes should be distributed as soon after the meeting as possible. The
7. Arrange for a recorder. The recorder takes notes on paper, laptop or on flip charts. Meeting notes should be distributed as soon after the meeting as possible. The
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
longer the lag, the less confidence the members have that their investment will result in action. For groups that meet regularly, the recorder is responsible for keeping previous meeting notes and agendas in one place where they can be referenced later such as from a notebook or shared network drive, etc
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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