Answers - Business

A couple of days ago I had a conversation with a volunteer, we'll call him Bob, in which he said, "I know online registration is the way to do it, I'

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

ve used it at another organization, but they say we don't have the budget for it here, so we're doing it manually." Bob's chuckle at the end of this

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

Examples of combination products may in

explanation was very telling. Free labour is a myth. Volunteers are in demand. Finding and recruiting these people takes time and effort and though t

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

here are no salary costs, there are expenses in covering:

The equipment they require
Possible office space
Someone to trai

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

n, manage and supervise their efforts More importantly, if you're wanting to keep your volunteers happy and keen to offer their time again,

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

Combination pro

you need to make sure that they feel their contribution is worth it. Getting them to physically send out and receive registrations, fax and phone con

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

firmations, process payments and enter data, especially when they are aware of the automated systems now available that do it all for you, is not the

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

best use of their skills and they know it. A smarter use of their time would be getting them to:

Market your event to drum up more particip

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

ants and generate more revenue.

Find sponsorship for your event to help cover costs.

Put more effort into the actual planning of th

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

e event, so it runs smoothly, is enjoyed by the participants and has them wanting to attend the next one.

Follow up with people to thank the

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

for attending the event.

Strategizing how to make your organization run more efficiently and achieve the goals you have set.

Not

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

Following aspects would a

only will your volunteer's efforts bring in more money for your organization, but you will have given them a stimulating experience.

Another comment

dd to the challenges in developing combination products:

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

from one not-for-profit organization that recently stopped me in my tracks was:

"We don't need online registration because our Treasurer manually p

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

rocesses registrations by fax."

You wouldn't dream of paying your lawyer to pick up your office supplies would you? Or getting your accountant to do

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

your laundry?

The problem here, which I've found to be common in not-for-profit and charity organizations, is the perception that they can't afford

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

to use online registration - have no allocated budget for it. It's like saying we aren't going to buy a computer because it's an expense. If you don'

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

Professional from academic institutions, pharmaceutical industries, health care indust

t have a computer you can't run an organization. The same applies with online registration, you can't afford not to. Here's why:

People now

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

expect to be able to register for events online and if you don't offer this you stand to miss out on registrations and therefore revenue.

.

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

line registration costs are minimal when compared with those you'll be saving by no longer doing it manually. It will also pay for itself by ensuring

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

Companies that provide selfless information through particip

happier, more efficient and productive employees and volunteers. In this way it can be thought of as an investment, rather than an expense

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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