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My students come in prepared. They know the drill. But, workshops that aren’t well organized often lose the interests of the artists they are trying to m

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

otivate. To run a workshop successfully, you have to be ready when the students come in your door.

Sometimes as artists we get so used to doing art for o

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

Examples of combination products may in

urselves that we forget how to teach it. I’ve sat in on some art workshops and watched the lesson just fall away because the artist, one of my former stud

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

ents, had forgotten how to express the art concept for the day’s lesson. That should never happen.

You might not have a great amount of time on your hand

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

s. But if you are running an art workshop, you should find the time to review what concept you are going to be getting across for the day. You already kn

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

Combination pro

ow the material. But, it’s in the back of your mind somewhere. All you have to do is review the material and get it all back to the forefront of your min

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

d.

It normally takes me about five minutes to go over everything that I’m going to be introducing to a certain class. Five minutes isn’t at all hard to f

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

nd. And yes, I still have to review my own material. That’s nothing to be ashamed of doing. If you don’t know those small details, you will fall flat on

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

your face. It’s not a major thing when all you are doing is refreshing.

But, introducing a concept only takes a few minutes anyway. After that, it’s ha

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

nds on experience. Other students can get involved in the learning process. You should encourage that. It gets them excited. They stay motivated. And

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

we all learn from teaching. Even if a student of mine only understands the material a little bit, through teaching all the details come together and my st

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

Following aspects would a

udents who are helping others reinforce what they have already learned.

That’s a positive force in my art workshops. Flexibility and adversity are the ke

dd to the challenges in developing combination products:

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

y. You are the facilitator who brings a new concept to the class. Then you allow your students to explore it for themselves. That’s the touch that invit

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

es participation and it never fails. My students are more prepared to deal with their students when they get the chance. They have already fielded questi

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

ns. They have already been introduced to misunderstandings and they’ve had to battle their way through them in order to help others to a greater understan

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

ding. That’s a lesson in itself.

Most of my adult students look forward to the day when they can run art workshops for themselves. The act of participat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion drives them forward. In my classroom, the get a dry run so to speak. They get to be the student and the teacher in the same period. The more they he

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

lp, the more they want to help. And the art workshop centers are exploding.

If you think you can’t handle an art workshop on your own, you should come an

.

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

d sit in one of mine. You’re always welcome. You’ll see how easy it is to introduce an art concept. Then, if you handle it correctly, you’ll see how eas

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

Companies that provide selfless information through particip

y it is to motivate students to help other students. The art produces itself. That art is the art of art workshops. Getting everyone involved is the key

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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