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Main Subject - Chairing A Meeting The Most Effective Way
How many times have you attended a meeting where the only thing that gets decided is the date of the next meeting? Or where one person dominates the meeting? Or the meeting is swamped with triv
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
ia or unrelated information?
It is a commonly held assumption that chairing a meeting is simply a matter of reading out the agenda – that is assuming there is an agenda and that the addenda act
It is a commonly held assumption that chairing a meeting is simply a matter of reading out the agenda – that is assuming there is an agenda and that the addenda act
; 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
ally covers the topics which are most pertinent to the matter in hand.
Chairing an effective meeting is a skill. One that is learnable. Outlined below are some simple principles; which if fol
Chairing an effective meeting is a skill. One that is learnable. Outlined below are some simple principles; which if fol
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
owed can result in focussed efficient meetings where everyone feels their opinion is valued and the job gets done.
Rule number 1 – there is no place for ego. As the Chair Person you are the fa
Rule number 1 – there is no place for ego. As the Chair Person you are the fa
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ilitator, the most effective are those who listen, who use open ended questions to tease out reasoning and to involve others.
Rule 2 –. Be very clear about what is the purpose of the meeting?
Rule 2 –. Be very clear about what is the purpose of the meeting?
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Do you want lots of ideas – to brainstorm possibilities, identify the implications of things already identified, broad-brush strokes or determining detail.
Rule 3 – Be prepared, create the age
Rule 3 – Be prepared, create the age
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
da, have any supporting papers prepared and circulated in plenty of time so that others have time to read in advance
Rule 4 – – At the beginning of the meeting ensure that all parties are intr
Rule 4 – – At the beginning of the meeting ensure that all parties are intr
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
duced, keep it snappy. Set out clearly what sort of introduction is required: name and role, or background information. Give the time scale e.g. “Please introduce yourself give a brief outline
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
of your experience, no more than a minute.”
Rule 5 – Set explicit parameters for the meeting from the outset: “By the end of the meeting we need to have achieved ……. We are going to concentrat
Rule 5 – Set explicit parameters for the meeting from the outset: “By the end of the meeting we need to have achieved ……. We are going to concentrat
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
e on principles today so save the specific detail for the moment”
Rule 6 – Have high expectations. If the meeting is due to start at 10.00am start on the dot who ever is there, they will get t
Rule 6 – Have high expectations. If the meeting is due to start at 10.00am start on the dot who ever is there, they will get t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e message. Start late to accommodate late- comers and they will assume it is ok to come late. Be clear about end times too. If you have asked colleagues to read materials before the meeting d
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
n’t read them out. The next time you ask them to read beforehand they will assume it is not worth the effort. Have high expectations and stick to them.
Rule 7 -What ever decisions are agreed
Rule 7 -What ever decisions are agreed
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
t the meeting MUST STAND. If you are unsure about their validity set up as a pilot with an end time agreed. Don’t put the decision up for grabs if you are not happy to run with the outcome. Yo
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 can give a structure for decisions which make it absolutely clear what is open to negotiation and what is up not.
Rule 8 – Involve all parties. Ask questions to specific people if they are n
Rule 8 – Involve all parties. Ask questions to specific people if they are n
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
t taking an active part in the proceedings, “What do you think about…… Fred” If others are dominating value their contribution but involve others “ Thank you Bertha that’s very helpful, what do
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 rest of you think about what Bertha has offered?”
Rule 9 – Keep the meeting on track, identify how things will be recorded, summarise the discussion, identify points for action, who will do
Rule 9 – Keep the meeting on track, identify how things will be recorded, summarise the discussion, identify points for action, who will do
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
hat, the time scale for action, how things will be monitored and by whom and when
Rule 10 – model good meeting behaviour and accept nothing less from colleagues. Taking a positive part in the
Rule 10 – model good meeting behaviour and accept nothing less from colleagues. Taking a positive part in the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
activity, being generous with ideas, listening to others, no aggression, bullying. A healthy professional discussion where diversity of ideas and approaches are constructively used to create th
.
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
best solution and not as personal attacks is the ideal.
If colleagues are going to give of their best they need to know that all contributions are valued, that they will get credit for their i
If colleagues are going to give of their best they need to know that all contributions are valued, that they will get credit for their 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
eas and that the whole organisations is strengthened by the collective success rather than scoring points off one another. As Chair Person it is you who will set the tone and manage the process
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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