Advice Pool - Reference and Education

Many school districts now require homeschoolers to present portfolios showing their student's progress in an organized fashion. This is actually a very convenient method of recording whenever it is done properly. Here are some ideas on how to create, maintain, and present your homeschool

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

portfolio for a successful assessment, evaluation and review.

First of all, it is important to have a firm grasp on precisely what a homeschool portfolio is. Basically, a homeschool portfolio is a collection of materials that are used in order to showcase what your child has learned ov

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

Examples of combination products may in

er the course of the "school year." This is important because numerous states require an annual assessment of homeschooled students either via testing or the presentation of a portfolio. While it may seem that keeping a portfolio is only good in so far as you need to comply with the law.

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

This is not the case however. Portfolios can also help parents and their children to record their progress and achievements. This becomes even more important once a child has reached high school and needs a diploma.

Now that we understand the importance of a portfolio, it is also impor

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

tant to understand that there is no right or wrong way in which to create a portfolio. It is up to the parent and/or child what materials the portfolio will contain. However, it is a good idea to choose a variety of material in order to reflect what the child has learned, experienced and

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

Combination pro

accomplished throughout the year. Some items that should be included in your portfolio are: Suggested items to include are:

(1.) A journal which contains notes about activities and the progress that has been made.
(2.) A list of resources (ie books, computer software, games, toys

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

and outside classes).
(3.) Samples of the child's work (ie samples of creative writing and drawings, text book or workbook pages, and if possible you may include audio or video tapes of your child singing, playing a musical instrument, reading aloud, or taking part in a a dramatic

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

performance - pictures will also sometimes work well in place of audio or video tapes).
(4.) Photos of field trips, artwork, projects and family life.
(5.) Brochures and booklets from field trips and other activities.
(6.) A list of books that the child has read including

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

both the title and the author.
(7.) A list of your goals for the year.

While this may seem quite overwhelming, you'd honestly be surprised at how easily you can accomplish this when you start preparing your portfolio at the beginning of the year. Simply use a three ring binder an

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

d add paper for your journaling. Start off by listing a few of your goals for the year and what resources you'll be using to achieve those goals (these can be modified throughout the year as needed). Then begin collecting samples of work, organizing them by subject, and punching holes in

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

them to place them in your binder. Always have at least a throw away camera at hand so that you can take pictures of anything that you'd like that your child does (ie reading, playing, dancing). You'll also want to take pictures at field trips as well as pictures of your child's projects

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

Following aspects would a

and creations. These pictures can either be placed in a photo album or if you're feeling really craftsy you could organize them into a scrapbook. You'll also want to make sure to hold onto any brochures or other paper items that you collect while on an educational outing. These can be e

dd to the challenges in developing combination products:

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

asily placed in clear see-through sheet protectors. This is also a good time to begin accumulating a list of books that are being read.

Once you have put together the beginnings of your portfolio, don't stop there. Regular maintenance (I suggest weekly as it will help you to write your

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

lesson plans for the following week) should include regular journal entries and an ongoing collection of work samples, photos and whatever else you wish to include. Some school districts will require a quarterly assessment throughout your homeschool year. This is a time for parents and c

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

hildren to reflect upon their progress and accomplishments from the previous months. Yet, even if your school district doesn't require a quarterly review, you won't want to wait until the end of the year to scramble and race to put together a portfolio that your school district will appr

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

ove of. Neither you nor your child deserve having to go through the unneeded stress of having to sort through all of the material that has been collected throughout the year.

When it is time for review you may choose to remove some of the materials from your portfolio. You will find tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

t some of these things simply do not properly reflect what you've accomplished throughout the year. If/when you decide to weed through your portfolio, you need to remember that the purpose of the review is to provide a general overview of the homeschool year, demonstrate that the child i

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

s engaged in homeschooling and that progress is being made.

The portfolio review can be exciting since it provides both parents and children with a time to talk about what they've been doing at home. When discussing this with your child, you may find it helpful to write down a summary o

.

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

f the items that you wish to highlight during your year before the review. For instance, if your child learned to read or master a skill you may wish to point this out to the reviewer. Of course, you should never view your portfolio review as a time for you to be judged or ridiculed. It

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

Companies that provide selfless information through particip

is a time to listen, learn and support from your reviewer. Your child does not need to be present during this time. However, if your child wants a chance to "brag" about their accomplishments and progress to other homeschoolers, then this review is a perfect opportunity for them to do so

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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Advice Pool - Creating, Maintaining and Presenting a Homeschool Portfolio

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