Useful Advices - Business

As more of our population reach retirement age, retirees are looking for something to keep them busy. People volunteer for various reasons, when we have children, we volunteer to work with our children in scou

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

ting, church work, school functions and sports. With more free time available as we retire, we volunteer at hospitals, churches, etc. As a volunteer myself, I can understand some challenges when working with

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

Examples of combination products may in

volunteers.

The first thing I ran into is that organizations want to compensate volunteers in some way for the work they do. In my opinion this is not what a volunteer expects, or they would not volunteer, bu

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

t take a part time job. When someone volunteers they do not expect anything in return, and if given money, gifts or gift cards, may feel that something is taken away from the act of volunteering. A simple tha

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

nk-you to the volunteer as a show of appreciation is all that is normally needed. Someone who volunteers usually gets great satisfaction from doing a job well and seeing the results of their work.

The next it

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

Combination pro

em that frequently comes up is the issue of control. If you hire an employee for a specified job, then you control the actions of that employee, this is not so with a volunteer. A volunteer will offer service

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

s for something that they enjoy doing. They usually have very defined ideals about what and how they work. From the organization point of view, the choice is whither to accept the help or turn it down. You c

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

an certainly work with the volunteer and discuss the details of a project, but care must be taken not to push or try to change the direction that the volunteer wants to go. I am not saying to let the volunteer

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

run your organization, you must have guide lines and limits and these should be made clear from the start. Keep in mind that you don't fire volunteers, you run them off. If you have a specified job 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

would like the volunteer to perform, then offer it to them in a way that they will be comfortable in turning down. Be sure that they buy into the project before accepting it. This is not only necessary with v

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

lunteers but works well with employees as well.

Another problem I have seen involving volunteers, is when someone is hired to take over the job that a volunteer was doing. If you depend on volunteers for a lo

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

Following aspects would a

t of the work, for example people that do volunteer work for churches, and you hire someone to take over the job, you not only risk losing the person as a volunteer but as a church member also. You cannot take

dd to the challenges in developing combination products:

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

the volunteer for granted or insult them by just replacing them. If someone is offering their services like mowing the church yard and you start hiring someone else to do the job, how do you think the volunte

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

er feels? If there is a problem with the frequency of the mowing or the quality of the work, then it should be discussed very carefully with the volunteer and maybe you work out a schedule with the volunteer m

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

owing one week and the hired person mowing one week. Move slowly and make sure that everyone is comfortable with any change before acting.

The last thing I want to discuss is the motive of the volunteer. Whe

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

n someone offers free services, make sure that you know what their motive is. Discuss this with them at length before accepting their offer. In a church for example, you may have someone who feels that they m

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

Professional from academic institutions, pharmaceutical industries, health care indust

ust work to gain acceptance from Christ and the Church, if your church is like ours then entering Heaven is not based on works. This is the gift that Jesus gave to us, we cannot earn it. I have seen some volu

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

nteers in the church that work hard, but do not behave as Christians. I would question their motives for being there. Then you also have a small number of people who may want to just cause trouble and enjoy i

.

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

t. They may volunteer just for the pleasure of interfering or stirring up things. I have also seen people offer services and then try to wheel and deal in order to make a profit from the organization.

If your

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

Companies that provide selfless information through particip

organization uses or depends on volunteers, then you have many challenges. We need volunteers and people want to feel needed. It is a wonderful and rare thing when two needs can be satisfied at the same time

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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The General Services Administration is a direct vendor of the U.S. Government and to become a GSA approved vendor one must follow the protocol that the GSA sets to become an exclusive vendor.

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