Advice Pool - Reference and Education

Once the decision is made to homeschool, the next major issue is which curriculum or methodology to use. While there are pros and cons for every option, this article will focus on

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

homeschooling with a packaged curriculum.

A packaged curriculum will usually include all the books, lesson plans, and scope and sequence planning needed for an entire school year.

; 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 providers also include additional services for enrolled families. These services can include counseling, grading, report cards, and even diplomas. While this path is often mor

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

expensive, there is the advantage of having everything already planned out in advance. This alone is a great time saver, which becomes more of an issue when there are several chil

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

ren being homeschooled in one family.

Another point to consider is accreditation. When a program is accredited, it means that it has been reviewed by an outside agency or committe

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

Combination pro

and has been determined to meet certain standards. Why would this be important? This will help greatly when time comes to apply to college. If the student has a high school diplom

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

from an accredited high school, there should be much less difficulty proving to admissions offices that a high school education has indeed been completed. Also, credits may be mor

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

easily transferred to another school if necessary.

When we first decided to educate our children at home, I was faced with researching and planning what to cover in a school year

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

for four children - grades 6, 4, 2, and preschool - with about a month to have it complete. The packaged curriculum I chose from Seton Home Study School proved to be invaluable. As

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

I was brand new at this, I honestly did not know where to start. The more I read about the various educational methodologies and the limitless choices of textbooks, the more I real

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

zed it would make more sense to enlist the help of a company with many years of experience.

By using a prepared curriculum, I can be assured that each child is covering all the mo

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

Following aspects would a

st important topics and acquiring the necessary skills. The lesson plans do just that - plan out each lesson for us, including many suggestions for additional activities and enrich

dd to the challenges in developing combination products:

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

ent. They also include many recommended resources, especially pertinent websites for further study.

One of the chief complaints about packaged curricula is that they are not very

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

lexible, and tend to be quite rigid regarding what to do when. Our experience thus far has not been so. The program we use emphasizes that parents should adjust the program to fit

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

he child, not the child to fit the program. In reality, nothing is actually “required.” We can use or skip any suggestions we choose. The only true requirements exist only if you w

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

nt an actual report card or diploma. Certain assignments must be completed and submitted in order to verify completion of the material. I find that keeping a portfolio of work that

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

Professional from academic institutions, pharmaceutical industries, health care indust

has been graded by an outside party is a good “insurance policy” against the regulations imposed by our state.

While I readily admit that not everyone will work well with a packag

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

d curriculum, this option does provide many advantages. For anyone who is just starting out and has little or no experience working out a plan of study, a prepared curriculum provi

.

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

es a solid beginning and helps the parent learn more too. Many families will start with a complete packaged curriculum, and then as time goes by, they start making modifications an

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

Companies that provide selfless information through particip

adjustments as they gain experience and confidence. As can be seen, the many packaged curricula available today can prove to be a very useful tool for many home schooling families

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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