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Having an agenda template that works well for you, week in, week out, creates a consistency which gets your people bought into the process. Delivering

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

an efficiency and effectiveness which makes the most of the valuable time you have together. Key points to note are:-

Circulate
Share

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

our agenda in good time, well before your meeting (with reading material for preview). This gives time for review, preparation and challenge.

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

Roles
In a meeting there are various roles to be taken on from the start. Chair, notetaker, facilitator, reviewer and other, more specific roles

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

These should be clearly stated on the agenda in advance of the meeting.

Items for Discussion
Items on your agenda need to be selecte

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

d carefully and only be relevant for the grouping of people who get together. Time is precious, so make sure that when together, only things whic

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

need everyone's input are given time.

Set Timings
Get clear on your agenda just how long the meeting will last and how long will be

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

evoted to individual items on it. This gives clear indications of what will happen in meeting.

Ground Rules
Within your agenda will be

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

some rules of how the meeting process will work. It is important to set standards of behaviour which everyone signs up to.

AOB
Often i

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

ncluded in agendas, this item is one that really should not be there. Good preplanning before the agenda goes out should mean that all items are

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ncluded at that point and, where dispute occurs, the meeting lead takes a decision. AOB can easily take a meeting off the rails and lead to missing ti

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

e agreements.

Action Points
As the meeting progresses there will be action points that individual meeting members will be accountable

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

or. By having a spot on the agenda for a quick review, prior to circulating these in writing, everyone will be clear on what is expected of them.

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

i>Parked Items
Sometimes during a meeting, items arise which whilst important, are outside the scope of that particular meeting. So by both 'p

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

rking' them during the meeting, thus validating their importance, and having a specific point to check the next steps for them is clear, they do receive

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

ttention. This then allows the meeting purpose to be maintained.

Next Meeting
By ensuring the date of the next meeting is an agenda i

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

em, this serves three purposes

It indicates to the meeting attendees follow up meetings
It gives an indication of when agreed action points

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

from the meeting are likely to be required

Finally, it reminds the person responsible for the agenda to agree a clear date during the meeting - i

.

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

not, it is likely to slip.

Meeting Review
Your agenda should also be an ongoing learning tool. As such, and to ensure your meetings

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ruly make a difference, there is a real benefit in reviewing how things have worked in the meeting - for all participants. Agenda it.

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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