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DEVELOPING LESSON PLANS: In developing lesson plan formats, two things are paramount: extr

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

aordinarily careful documentation and room left for possible changes. Sloppy accounting of

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

Examples of combination products may in

the direction your class will be going is worse than none. And documentation that doesn’t

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

ave leeway for change is almost instantly obsolete. The types of plan formats generally us

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

ed are the: outline, sentence outline, narrative outline, narrative. The primary differenc

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

Combination pro

is in the amount of information and narrative in the body of the presentation. Your plan

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

or a presentation should be at least a sentence outline or preferably a narrative outline.

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

READING LESSON PLANS: All maps have common information, called the legend, which tells y

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

u how to read them. The lesson plan should also have a legend (the cover sheet) which tell

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

the trainer what the learning environment will be. The cover sheet includes the course ti

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

le, the lesson title, the length of time for the lesson, the target audience, the performa

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

Following aspects would a

nce objectives, the evaluation procedures, and the equipment and supplies needed for you a

dd to the challenges in developing combination products:

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

d your students. Although your department may have a specific format for this information

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

he purpose is more important than the format.

MAKING INFORMATIVE LESSON PLANS: --The cour

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

se title or lesson title should accurately reflect the content of the lesson or course and

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

be stated simply. --The length of time for the lesson should include time required for les

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

Professional from academic institutions, pharmaceutical industries, health care indust

on presentation and suggested time, date, and hour at which lesson delivery would be most

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

effective. --The target population entry shgould answer several questions. What skill leve

.

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

will the trainees have? Is the content appropriate for the audience? Will the audience be

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

Companies that provide selfless information through particip

homogeneous, or a “mixed” group of people with different backgrounds, ages, and job skills

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 You - Training / Presentations: How to Begin a Lesson Plan

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