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Other Articles - How To Prepare A Modern Meeting Agenda
The agenda is the key to a successful meeting it is the roadmap, the guide, the plan. Studies have shown that up to 70% of meetings either have no agenda or have a poor agenda which is not helpful. In this article, you will see that there are some steps which you can take to make sure your agenda will contribut
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
e to making your meeting more productive. There are also hidden advantages. If the agenda is well constructed, you will also spend less time in the meeting and more time actually doing the things the meeting determines need to be done!
1. Remember the key the more detailed the agenda, the more focussed and gen
1. Remember the key the more detailed the agenda, the more focussed and gen
; 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
erally, the shorter the meeting will be.
2. You cannot expect intelligent decisions if people do not have time to think through the issues before the meeting. Therefore, agendas need to be sent out in advance, not given out at the meeting. People who have genuine desire to reach the best decision, and people who
2. You cannot expect intelligent decisions if people do not have time to think through the issues before the meeting. Therefore, agendas need to be sent out in advance, not given out at the meeting. People who have genuine desire to reach the best decision, and people who
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
are organised, always have their agendas distributed in time for people to give thought to the issues.
3. Adopt the strict policy that if an item is not on the agenda, it will not be discussed at the meeting. Do not allow items to be raised without notice. Allow only true emergency items to be exempt and allow
3. Adopt the strict policy that if an item is not on the agenda, it will not be discussed at the meeting. Do not allow items to be raised without notice. Allow only true emergency items to be exempt and allow
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
o other exceptions. Organised people have no difficulty with this. It is only disorganised or "slack" people who object to this because they cannot get their act together. Research shows, that if an item is raised without notice, the meeting will spend time talking about it, but then defer the decision until 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
next meeting anyway when there is notice given. It just wastes time.
4. Have a "cut-off" time for agenda items and make sure everyone knows the cut-off time and then also "publish" the distribution time for the agenda. So, for example, it would work like this: The minute taker would let everyone know that items
4. Have a "cut-off" time for agenda items and make sure everyone knows the cut-off time and then also "publish" the distribution time for the agenda. So, for example, it would work like this: The minute taker would let everyone know that items
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
for the agenda must be with the minute taker by, say, noon on Wednesday, the agendas will be sent out (by the minute taker) at say, 4.00pm Wednesday (allowing time for the pre-meeting meeting with the chair) and the meeting will be held at 3.00pm Thursday. Everyone would know the timetable for every meeting and t
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
hen no-one has any excuse not to follow the timetable.
A second example for clarity: Let everyone know the cut-off time for agenda items is, say, noon on the third Thursday. The agenda will be emailed or faxed by close of business that same day, for the meeting on the following Monday.
5. Once you have all of t
A second example for clarity: Let everyone know the cut-off time for agenda items is, say, noon on the third Thursday. The agenda will be emailed or faxed by close of business that same day, for the meeting on the following Monday.
5. Once you have all of t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e above in place, then you can eliminate business without notice. This is often called "general business" or "other business". Modern meetings and the most competent chairs of meetings, adopt the practice "if it isn't on the agenda then it isn't discussed". Everyone has the same opportunity to put anything they
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
want to on the agenda so no-one is disadvantaged.
6. Insert an agenda item immediately after Confirmation of the minutes "Action Status Report". In this report (which is written, not verbal) you list the current status of every item of action which is outstanding, as well as the completed items assigned at t
6. Insert an agenda item immediately after Confirmation of the minutes "Action Status Report". In this report (which is written, not verbal) you list the current status of every item of action which is outstanding, as well as the completed items assigned at t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
he last meeting. The minute taker would prepare this document immediately before the meeting.
Example status statements are: Completed, Not yet started, 70% completed, Completion expected in 3 days, Stalled require resources, Stalled - Awaiting information or responses, Waiting for CEO's signature, etc.
7. O
Example status statements are: Completed, Not yet started, 70% completed, Completion expected in 3 days, Stalled require resources, Stalled - Awaiting information or responses, Waiting for CEO's signature, etc.
7. O
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
nce you have the Action Status Report in place, then you can eliminate Business Arising from the Minutes. Many people think that Business Arising from the minutes is going through every item on the last minutes and asking if there is anything to be said. This is a complete waste of time. Everything which would no
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
mally appear in business arising would either be in the Action Status report or will be worthy of an agenda item in its own right.
8. Sort all correspondence into 3 categories 1 junk, 2 For information only, 3 Decision required and then eliminate correspondence as an item on the agenda.
Correspondence i
8. Sort all correspondence into 3 categories 1 junk, 2 For information only, 3 Decision required and then eliminate correspondence as an item on the agenda.
Correspondence 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
n category 1, (junk) should be disposed of. Correspondence in category 2 (For Information) should be placed in a manila folder or ring binder file and passed around the meeting for people to look at as the meeting progresses. There is no need to list it in the minutes. Correspondence in category 3 (Decision requi
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
red) should each be listed on the agenda as a separate item every decision as a separate item - so they can be dealt with at an appropriate time and in an appropriate way.
Outward correspondence has been sent there is little to be gained by discussing letters which have been sent. Outward correspondence can
Outward correspondence has been sent there is little to be gained by discussing letters which have been sent. Outward correspondence can
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
be listed in the Action Status Report as its own item. It is pointless to confirm or ratify outgoing correspondence it has been sent!
9. Place a (D) or an (I) next to every agenda item indicating whether it is a decision required item (D) or an information item (I).
10. Do not allow verbal reports without a w
9. Place a (D) or an (I) next to every agenda item indicating whether it is a decision required item (D) or an information item (I).
10. Do not allow verbal reports without a w
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
itten summary. Insist that every report is written and preferably no more than one page. That report is then included in the minutes. (It is not the minute takers job to write notes about someone's report it is up the person giving the report to provide their report for the minute taker to include.) The most ef
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
fective chairs of meetings do not allow verbal reports unless they are accompanied by a written summary.
The next point is by far the most important. Make sure you adopt this and your meetings will run effectively and efficiently.
11. Finally, and most important, ensure that every agenda item shows clearly what
The next point is by far the most important. Make sure you adopt this and your meetings will run effectively and efficiently.
11. Finally, and most important, ensure that every agenda item shows clearly what
.
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
is required from that item being on the agenda not just a vague topic. Every agenda item needs to be expanded so that every person at the meeting knows clearly exactly what is required at the end of discussion on that item. Fort example, an item may require that a "decision to be made on which software the org
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
anisation will buy;" or a second example, "decision required on whether or not to employ an extra admin person;" or a third, "decision required on whether to extend the funding for the Acme Project and if so, by how much". Once you have this in place, then your meetings will run smoothly and be much more focused
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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