Advice You - Business

LESSON PLAN DEVELOPMENT: Lesson plans, believe it or not, are a lot like the maps you have in the back

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

seat of your car. They’re probably not covered with the ketchup and pencil marks that your maps are,

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

Examples of combination products may in

but they are directional guides. You need some way of checking to see if you are on the right road in

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

our classroom or on the highway. A lesson plan is really nothing more than a map of where you and your

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

students will be heading for the time you are together. To paraphrase the American Express Card comme

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

Combination pro

rcial, “Lesson plans -- don’t leave home without them.”

“DO I REALLY NEED A LESSON PLAN?” Yes, you do

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

An important part of the preparation for your session lies in your lesson planning efforts. There are

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

several good reasons for constructing a lesson plan for every session in which you are involved. Prop

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

erly outlined, a lesson plan will outline the priorities you want to cover in a logical and systematic

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

sequence. The plan will help you stay on the proper track and lead you to your stated objectives witho

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

ut time-consuming tangents and loss of momentum. 3. By staying with your game plan, you are better ass

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

Following aspects would a

ured of having your trainees attain the prescribed goals. With a well-constructed format, you’ll be se

dd to the challenges in developing combination products:

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

f-confident, knowing that you are prepared in advance. If your session is one that is repeated in othe

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

r groups, the preparation and planning you have undertaken can be easily used by another instructor in

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

your absence or by you for a different group of trainees.

FOLLOWING THE DEVELOPMENT PROCESS: An effe

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

tive lecture or training presentation is the result of a specific development process. The effort of p

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

Professional from academic institutions, pharmaceutical industries, health care indust

reparing your lesson is really only the beginning. Once the guidelines for presenting your material ha

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

ve been established, however, maximum impact can be achieved far more certainly and with far less anxi

.

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

ty for the instructor. You can be assured that there will be no waste of time in the classroom. Every

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

Companies that provide selfless information through particip

minute of the valuable time allotted for training will be used to the fullest by you and your trainees

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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