Main Subject - Business

MAKING INFORMATIVE LESSON PLANS: --The performance objectives should answer this very basic question — what shoul

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

d the trainees be able to do at the end of the training period that they were was not able to do at the beginning

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

Examples of combination products may in

of it? --For evaluation procedures, how will the trainee’s accomplishment of performance objectives be demonstrat

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

ed or measured (written test, skill test, skill demonstration)? Evaluation procedures should provide documentatio

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

of the achievement of all performance objectives. --For equipment and supplies needed, what is available? What m

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

Combination pro

ust be used? What cannot be used? What unusual items will be needed? Any special student materials? Instructor ma

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

erials? Handouts? Lesson plan for the students? Manuals? Visual Aids? Props? --When entering space requirements c

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

alculate room size, number of rooms, seating requirements, seating arrangement, writing surface needs, and any sp

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

cial training environment needs.

PERFORMANCE OBJECTIVES: The cover sheet or legend for the lesson plan should in

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

clude perofrmance objectives. Any statement comprehensively describing the intended outcome and instructional int

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

nt should include the following: --a description of intended outcome in terms of student performance --a statemen

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

Following aspects would a

t of what learners must be able to do or perform when they demonstrate mastery of the objective --a description o

dd to the challenges in developing combination products:

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

relevant or important conditions under which the performance is expected to occur --a statement of the criteria

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

by which achievement will be judged --a measurement of how well must students perform for your satisfaction.

A

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

RITTEN LESSON PLAN: When you know what you are going to teach, who you are going to teach it to, what you will ne

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

ed to teach it, and what you want the student to know or do, you must put this all together into a written plan.

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

Professional from academic institutions, pharmaceutical industries, health care indust

ut stop and reflect for a minute -- How do we learn? The last time you learned something, what processes did you

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

go through, and in what order? You probably learned them in this general order: Opportunity and motivation to lea

.

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

n, step-by-step, practice or applied learning, measure against a standard, reflect upon the experience. Since the

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

Companies that provide selfless information through particip

se are the steps we follow to learn things naturally, the class (and the lesson plan) should reflect this process

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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When you have received the job offer and you think the package needs improving before you accept the position, what can you do?

When many companies go downhill, they never recover. Far too many of them continue to fall right into oblivion. They either go out of business or just become irrelevant companies. We saw this vividly in the 2001 bear market. The vast majority of the Internet companies were gone within a year.

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