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How do you find groups that are in need of speakers
(at no charge)?

Findi

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

ng groups that use speakers is not difficult. I find that most organized servic

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

Examples of combination products may in

groups use speakers for their regular meetings. I am a member of Rotary and ha

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

e been for nearly fifteen years. In that period of time, the clubs use a speake

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

almost every week of the year. There are thousands of Rotary clubs all over th

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

Combination pro

e world. The most important thing to remember, especially for Rotary, is that t

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

e topic must be of interest to the members and that you cannot sell your servic

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

s to the group. Many a good speakers have not been recommended to other clubs a

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

they tried to sell attendance to their speeches or training sessions.

I find

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

that other groups such as Lions, Kiwanis, churches, PTAs, etc., all want to hea

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

good talks and they do not want to be sold a bill of goods. You need to rememb

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

Following aspects would a

r that your goal is to get your name known, not to sell. If one group likes you

dd to the challenges in developing combination products:

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

speech, they may give you referrals to other groups that would like to hear wh

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

at you have to say. Another great place to offer a talk is at the Chamber of Co

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

merce. Almost every town in North America has a Chamber. You will need to find

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

ut the protocols for putting on a talk, but most are open to new ideas and fres

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

Professional from academic institutions, pharmaceutical industries, health care indust

topics. More often than not, you will find out about groups through your own n

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

etworking efforts.

Even though some groups are easy to get on the speakers lis

.

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

, others will make it more difficult. They will want to know more about who you

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

Companies that provide selfless information through particip

are, why you want to talk to the group and how the topic fits for their members

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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