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Anyone can conduct a fund raising event. Many of these are non-profit meaning the proceeds collected doesn’t go to

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

anyone except the recipients. There are a few things people need to go in order to make this happen and here are

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

Examples of combination products may in

some of those tips.

1. The one who thought about it should have a clear idea as to what this event is all about.

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

Is this about raising money to fight AIDS or for those who don’t have enough to eat in some third world country. S

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

uch examples have been done for ages and this will continue as long as people are still suffering.

2. The next th

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

Combination pro

ing to think about is the type of event that will take place. Concerts raise a lot of money. A good example is the

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

Live Aid concert, which took place after the tsunami, hit certain parts of Southeast Asia.

3. After this has bee

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

planned, it is time to deal with the technical side of a non-profit raising event. When people offer money, a rec

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

eipt must be issued making it a non-deductible contribution.

If this is not done, the organization will have to p

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

ay taxes to the government. This means the money collected cannot be given in full to those who need it the most.

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

This is the reason that documentation is important in order to make this happen.

4. Another important factor in a

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

Following aspects would a

non-profit fundraising event is that there has to be a board of directors in place. These individuals don’t have

dd to the challenges in developing combination products:

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

to be politicians but ordinary people who are committed to the cause.

These people can come from different backgr

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

ounds that will have a special role to play from the planning to the execution of the event.

5. When the board ha

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

been formed, the next most important thing to get regardless on the scope of the non-profit raising event are vol

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

unteers that will help out until the project has been completed.

The five tips just mentioned are essential in th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e success of the non-profit fundraising event. No one in the group may have done this before making this a fun and

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

learning experience for everyone.

There will be medals or certificates of recognition once this project has been

.

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

completed. The group who worked together will be thanked by those who need it the most in some special way.

Givi

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

Companies that provide selfless information through particip

ng something without expecting anything return is not selfish and worth doing should the group want to do it again

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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