Advice Pool - Reference and Education

Here are some ideas to help you continue to make a difference for stressed, maladjusted, troubled, frightened, and vulnerable students during school vacatio

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

ns. These ideas are all taken from our web site, books, e-books and workshops.

*** Extend Your Reach: For some kids, their teacher may be the only sane, s

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

Examples of combination products may in

ober, caring adult they know, and then summer vacation comes. To extend the reach of teachers and other school-based youth workers who provide invaluable s

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

tability, safety, direction and nurturing, use this intervention: Address pre-paid post cards to the teacher (or other key school worker) at school, and giv

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

e them to the child on the last day of school. Ask the child to write or draw on the post cards then drop in the mail. Studies show that children who have

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

Combination pro

a sense of connection to the community do better on almost every measure including graduation rates, teen pregnancy, delinquency, etc. The post cards can

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

preserve a bit of that connection over the potentially lonely and difficult summer.

*** Connect Back: Before leaving for summer vacation, the teacher (or o

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

her school worker) can write up post cards from the teacher to the child, and ask the school secretary to send out the cards over the summer. The post card

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

s (or letters or small packages) can offer suggestions for summer activities, provide encouragement or contain specific activities that the child can do.

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

*** Find Linkages: Prior to the summer break, research community groups that will provide a summer connection for your neglected, troubled or lonely stude

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

nts. Groups such as Boys and Girls Clubs, the YMCA, YWCA and Big Brother, Big Sister can provide activities, mentors, camp experiences and other key link

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

Following aspects would a

ages. As delinquency tends to increase when youth are not involved in school or similar activities, it may be very important to structure summer vacation f

dd to the challenges in developing combination products:

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

or youth who would otherwise be largely unshepherded.

*** Leisure Time Management: Kids chronically claim there is nothing to do. Show that there is alwa

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

ys something to do. Divide your youth into 4 or 5 smaller groups. Ask each group to imagine they have each been given a small amount of money; one group m

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

ght be told they have $2.00, the next group might have fifty cents, etc. One group can be asked to imagine they were given no money. Now, ask each group t

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

o determine all the activities, events and hobbies a person could do with that small amount of money. Provide access to phone books, newspapers, the intern

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

Professional from academic institutions, pharmaceutical industries, health care indust

et, etc. to aid the groups to develop long lists. Write up all the groups' answers and distribute to your kids. Include a wide range of activities such as

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

visiting the library, playing hackey sack, reading, internships, sports, utilizing mass transit, volunteering, crafts, etc. Your kids will be amazed how m

.

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

uch there is to do when there is nothing to do!

*** Reach a Dream: Discuss how Martin Luther King Jr. worked to reach his dream. Ask your students what the

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

Companies that provide selfless information through particip

y are willing to do to reach their dreams. Suggest that the summer months may be the perfect time to gain or perfect the skills needed to reach each dream

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 - What Teachers Must Do to Help Traumatized, Victimized, Fragile, Distressed Students

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