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Meetings – they are often seen as a huge drain on time and resource. Poorly co-ordintated meetings are in

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

effective and time wasting. So what’s the best way to run a meeting and make the most of both yours and y

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

Examples of combination products may in

ur attendees valuable time. Follow our five step plan and you’ll be well on the way to an effective meeti

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

g.

1/ Prepare for your meeting

Make sure you have something meaningful to discuss and that your meeting

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 appropriately structured. Are you discussing last month’s sales figures? If so make sure you have the r

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

Combination pro

ght reports to hand for all attendees – if you have an agenda, make sure it’s distributed to your attendee

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

in advance of the meeting to allow them to prepare and gather any information that’s required, do you nee

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

d to book a meeting room, or obtain a projector? If so get it done in good time.

2/ Follow your agenda

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

An agenda to your meeting is crucial – it allows you to set out what you want to discuss ensuring that you

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

do not go off topic. A well laid out agenda comprises of date/time of meeting, location and points for di

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

cussion. Ensure that you also include a section for AOB (Any other business) that ensures you ensure that

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

Following aspects would a

all attendees have an oppourtunity to speak.

3/ Empower someone to chair the meeting.

Make sure that you

dd to the challenges in developing combination products:

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

meeting has someone to chair it. The chairman’s job is to make sure that you stick to appropriate conten

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

and keep to the agreed time. The chairman should also ensue that attendees do not misbehave and the meet

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

ing shouldn’t dissolve into arguments between opposing views.

4/ Ensure that everyone is able to contribu

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

e

Meetings are arranged to allow people to gather and discuss issues. In your meeting look to ensure tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

everyone is able to participate and that the meeting is not monopolized. Make an effort to ensure that a

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

l contributions are valued encouraging everyone to take part.

5/ Follow up with a set of minutes

Make su

.

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 that any meeting minutes are produced rapidly – minutes should comprise of a summary of discussions, dec

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

Companies that provide selfless information through particip

sions, actions and target dates. The minutes should also set the date and time for any follow up meetings

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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Businesses these days are stifled with inefficiencies brought on by bad legislation and brain dead regulators. But businesses have a choice; we have a way to fight the system. One way is to stop producing, raise prices and invest in better markets with higher returns and less regulation. As a matter of fact this is what many businesses do and are doing.

Are you in a dead-end job? It may not be what you know but who you know. Increase your income by mastering the art of office politics. Learn how I went from employee to executive by the age of 31!

Could the Crusades have been launched and the soldiers armed and fed without effective project management? Could the Great Wall have been built with ingenious natural materials and a team of millions over a span of a thousand years without project management? It is possible to say that the concept pf project management has been around since the beginning of history.

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