Advice Pool - Reference and Education

Are you thinking of home schooling your child or children in Florida? Wondering what the requirements are and how to get started? It’s really not as scary as you may think. Florida is actually a pretty easy state to begin home schooling in.

Home educ

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

ation, as defined by Florida law, is “sequentially progressive instruction of a student directed by his or her parent or guardian in order to satisfy the requirements of Statute 1003.21 and 1002.41.” Florida’s home schooling law is broad giving parent

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

Examples of combination products may in

s almost unending freedom in educating their children.

Basically there are six requirements that must be met to Florida home school.

1. Notify the District School Superintendent in your county of your intention to home school. The notice of intent m

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

st be filed with the superintendent’s office within 30 days of beginning your home school program.

Currently there is no “official form” that is used to supply notice but your written (or typed) letter of intent should include at the bare minimum the

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

following information; Name of child (or children), Birthday of each child named, Address and a Parent’s Signature. It is recommended that you send your letter of intent via certified or priority mail and file the receipt as proof in your child’s por

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

Combination pro

tfolio.

2. Maintain a portfolio of records. While there is no proper or “official” way to record your child’s home schooling progress you must maintain a portfolio of records. The portfolio must consist of two main parts; Documented Records and Sampl

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

Materials. Documented Records is defined as “A log of educational activities which is made contemporaneously (the documentation should occur at the same time as the instruction) with the instruction and which designates by title any reading materials

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

used.”

Florida home schooling law does not require lessons to be planned or approved in advance. Sample Materials is defined as “Samples of any writings, worksheets, workbooks or creative materials used or developed by the student.” Showcasing your

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

child’s “sample materials” can be accomplished in various ways. Keep in mind that whichever method you adopt to showcase your sample materials they need to be organized in chronological order for ease in showing educational progress. More elaboration

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

n this topic in the future... hopefully.

3. Keep your portfolio organized and available. Florida home schooling law requires you to make your portfolio “available for inspection by the superintendent or the superintendent’s agent, upon 15 days’ writt

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

en notice.” The last thing you will want to do is be scrambling around trying to remember what you did when for the last 3 months and what was the name of those books you read again…. The inspection is only to make sure that the portfolio is legal; th

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

Following aspects would a

e superintendent cannot evaluate its contents.

4. Submit your Annual Evaluation. The law requires an annual education evaluation by a Florida-certified teacher of your choosing. You are required to have your child or children tested annually and subm

dd to the challenges in developing combination products:

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

t the evaluation to the superintendent’s office no later than one year from your letter of intent date.

Alternatives to having an evaluation performed include; any nationally normed student achievement test administered by a certified teacher, a stat

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

e student assessment test, a psychological evaluation or any other method mutually agreed upon by the parent and the superintendent.

5. Hang on to those Portfolios, your going to need them. Florida home schooling law dictates that “The portfolio shal

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

l be preserved by the parent for two years.” Enough said.

6. Submit your Notice of Termination. If you decide to no longer home educate under 1002.41, move from the county, enroll your child in a public or private institution or if your child gradua

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

es or completes the Florida home school program you must file a letter of termination with the superintendent. The notice of termination should include the same information as the letter of intent and should be filed within 30 days of the date or ter

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

Professional from academic institutions, pharmaceutical industries, health care indust

mination.

7. Relax. Okay I know we said there were only six requirements but this one is worth mentioning. As long as there have been parents and children, “home schooling” has been happening. Today an estimated 1.6–2.0 million children are being tau

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

ght at home by their parents. By grade 8, the average home school student performs four grade levels above the national average.

Research has found that most homeschooled students are involved in a wide variety of outside activities, interact with a

.

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

road spectrum of people, and make positive contributions to their communities. Experience has shown that homeschoolers are well socialized and able to make lasting friendships across age and cultural divides.

Painless right? We promised it wasn’t tha

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

Companies that provide selfless information through particip

t bad and now that you have all of your legal bases covered you can concentrate on enjoying the home schooling experience and enriching the lives of your children through learning. Now all that’s left is to decide on a curriculum… Decisions… Decisions

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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