Suggest - Reference and Education

Well, as you probably know, they’re about to do it again … out will go the Birth to three framework and Curriculum Guidance for the Foundation Stage and in co

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

mes the shiny new Early Years Foundation Stage (EYFS).

So what’s it all about and, more importantly, is it worth having a good moan about?

It comes i

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

Examples of combination products may in

nto force in September 2008 so there’s plenty of lead in time. There’ll also be a lot of training available, so no need to worry on that score either.

Her

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

’s a brief summary covering what’s involved

The EYFS is a single development and learning framework for children aged from birth to five years. It draws

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

from Birth to Three Matters, the Curriculum Guidance for the Foundation Stage and the National Standards for under 8’s Day Care and Childminding into the one

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

Combination pro

ramework (so you’ll be familiar with the terminology).

Principles

The principle behind the guidance are the same – such as the importance of parents

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

as educators, key person for every child, relationships between adults and children, planning for the individual child, role of indoor and outdoor play etc et

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

.

What will be in it?

The framework will have two parts to it – the EYFS document itself (in other words what you must do to deliver early years prov

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

ision) and a CD-Rom (this will have the EYFS Profile and training clips).

So what does the EYFS look like?

Well, quite honestly, it doesn’t look all

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

hat different. There are still a range of Early Learning Goals as you’d expect. The Areas of Learning are now called Areas of Learning and Development. There

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

are six and the headings are slightly different:

Personal, Social and Emotional Development

Communication, Language and Literacy

Problem Solving, Reason

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

Following aspects would a

ing and Numeracy

Knowledge and Understanding of the World

Physical Development

Creative Development

As before, none of the six Areas of Development an

dd to the challenges in developing combination products:

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

Learning can be isolated and delivered on its own. There is an emphasis on assessing children’s progress (Look, Listen and Note), thinking about planning for

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

their development (Planning and Recording) so that you can put this in place (Effective Practice).

Look, Listen and Note

Those of you who use Tracke

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

s to observe and record children’s progress will be familiar with assessment based on observations. When the DfES produce the final EYFS documentation a new v

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

ersion of Trackers will be produced that will reflect the changes. The observations that you record in Trackers will help you with your planning – so importan

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

Professional from academic institutions, pharmaceutical industries, health care indust

in making the children’s learning exciting, varied and, of course, progressive.

Inclusion

There is, as you would expect, a good deal of emphasis in

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

the framework on your teaching (and your early years setting as a whole) being inclusive. This means that you need to have a good working policy covering issu

.

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

s like special needs, anti-discrimination, behaviour, bullying, disability and equal opportunities.

If you want to be kept up to date with what’s happening a

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

Companies that provide selfless information through particip

s far as the EYFS is concerned, and make sure that you've got all aspects of your inclusion policy covered, visit the QEd Publications website for information

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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