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For meetings to consistently deliver the required performance and hence outputs, it is critical

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

to have a prepared communication process in advance of the meeting.

This enables participants

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

Examples of combination products may in

to be aware and where appropriate prepare for the meeting in advance.

It also allows for them

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

to circulate any preparatory information and pre-reading before the meeting to minimise any inf

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

ormation-giving during valuable meeting time.

This time when all participants are together mus

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

Combination pro

be devoted to the interchange that can only happen when people are together.

The agenda forma

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

t may vary, but it will need to have some components which are common, as follows:-

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

cation and time and who

Preparation required

Review of previous agreed actions

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

jectives

Items to be discussed

Next meeting location and time

Review of meeting<

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

/ul>

By having this structure, it becomes possible for the right people to attend and to:-

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

Focus completely on outcome and purpose

Be prepared

Develop meeting skills

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

Following aspects would a

Exercise

1. Review meetings you hold, however informal, without agendas.

- How focused are t

dd to the challenges in developing combination products:

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

hey?

- How sidetracked do they become?

- What do you notice about behaviours of people who at

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

end?

- Describe how you feel at the end of three different meetings this week – some with and

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

some without an agenda.

2. Plan one meeting this week for which you would normally not have an

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

agenda using the agenda detail provided in the workshop.

3. Discuss the benefits and concerns

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

Professional from academic institutions, pharmaceutical industries, health care indust

about using an agenda

- What is better about having an agenda?

- What might be negatives abou

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

t using an agenda?

- How might you ‘sell’ these in a positive way?

Meetings are hugely valuab

.

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

e contribution ot business life, as long as they work well. Preparing people in advance is 'one

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

Companies that provide selfless information through particip

giant step for meetings, one giant step for value-creating interactions of like minded people'

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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