Answers - Business

Boring - that’s the last word we want to hear in our training evaluations! There can be 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

any reasons why our students feel that way. A common reason for boredom and confusion is

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

Examples of combination products may in

roviding too much information.

What factors contribute to this? Perhaps we want to show

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

that we understand the business. Maybe we want to give them a deeper picture in hopes tha

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

they will better comprehend the material we need them to understand. Sometimes, students

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

Combination pro

want more information than necessary and in answering their questions we actually bored

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

he others in the class. Too much detail may create confusion, boredom and may be a deterr

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

ent to learning.

Most trainers enjoy sharing knowledge with their students, and some tra

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

ners fall into the trap of getting so excited that they really want to share, share, and

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

share. Let’s face it - our students may not be as excited about the material as we are. T

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

o much detail may drive them to a point of pure frustration!

Avoid These Fatal Training

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

Following aspects would a

Errors:
• Going into too much detail with unnecessary information
• Sharing inf

dd to the challenges in developing combination products:

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

rmation that is off-topic or too difficult to understand

As you prepare for your

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

next training program, verify that you have a clear understanding of the material, your

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

tudents’ needs and the methods you will be using. Look at the material from their perspec

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 - what they already know, what they need to know, and what would just be a waste of

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

Professional from academic institutions, pharmaceutical industries, health care indust

heir time to know. The next step is selecting the most effective way to share the informa

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

tion with the group, which we will discuss in future posts regarding trainer training. D

.

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

not let distractions or questions take you off-course and avoid burying your students in

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

Companies that provide selfless information through particip

detail. Focusing on the necessary information is what will make you an effective trainer

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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Answers - Trainer Training: Details Getting In The Way

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