Main Subject - Business

Tom stepped into the meeting room, but from his perspective it might as well have been a jail cell. He was a prisoner in his own work day. Why? The PowerPoint slide projected on the screen said it all. “

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

Welcome to our Refresher Training.” Refresher training might be needed for some people but Tom already knew all this material . . . but the training was mandatory. Besides, he had a desk full of more impor

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

Examples of combination products may in

tant work. He told himself how stupid this mandatory training policy was; that he hated to attend training on stuff he knew.

Mary’s supervisor asked her to attend the coaching skills training being provide

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

d by the company. The problem was that Mary wasn’t a coach. She wasn’t even a supervisor. She didn’t see any value in attending this workshop. All she could think about was, “What good is this going to b

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

e for me?”

Kat was really excited about the workshop session she had registered for. It was on a topic she was interested in and wanted to learn more about. She saw how mastering these skills would help h

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

Combination pro

r reach her goals. She arrived early and sat close to the front. The problem became clear very early on though. The material was too basic. She already knew this stuff! She was disappointed to say the l

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

east. She put out her own money and time for something that was going to waste both of those things.

I’m guessing you can relate to at least one, and perhaps all of the scenarios you’ve just read. These a

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

re just some of the common barriers that get in our way of being the most productive learners: we are forced to be there, we don’t see the learning as relevant or valuable, and we feel like we already know

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

the material.

While these barriers are real, there are things we can do to jump over or break through these barriers – to make the time invested in these situations more valuable and useful to us. Here are

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

three specific suggestions that will help you in each of these situations and many more.

1. Use the time to review and focus. So you don’t want to be there, or feel that you already know the materi

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

l. So what? You are there. So be there (and get over yourself)! Rather than having your own little pity party, or being cynical about the material and the experience, use the time to review what you know.

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

Following aspects would a

Use the time as an opportunity to do some thinking. Reflect on your experiences with these concepts. Think of ways you can improve on what you already know. You may become a valuable resource to other le

dd to the challenges in developing combination products:

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

arners, or you may learn something new through your reflection. The time is there, use it wisely. Even if what you learn is different than what others learn, you will have made good use of your time, impro

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

ved your mood and outlook, and taken something valuable from your time spent.

2. Look for the nugget. Everyone can learn something new. Maybe you do know much of the material being covered. If tha

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

t is the case, be a detective. Look for and uncover at least one nugget that you had forgotten, that you have stopped applying, or one twist on something you already know well. Often one well applied nugge

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

will “pay” for your time invested many times over. And without sleuthing, it is value you would never have received.

3. Be a beginner. Remember what it is like when you first learn something new?

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

Professional from academic institutions, pharmaceutical industries, health care indust

You are excited, interested and having fun. Once we think we know it all, we stop looking for any evidence to prove ourselves wrong. One of the best ways to remove all of these barriers is to come to any

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

learning situation as a beginner, by asking yourself, “What can I learn?” The Zen saying states it well, “In the beginner's mind there are many possibilities, in the experts mind there are few.” Give yours

.

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

elf more options. View the world from a possibility perspective. Come to the learning table as a beginner.

These three suggestions can have a major impact on the value you get from any learning experience

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

Companies that provide selfless information through particip

(classroom or otherwise). Once you know and apply these strategies these common barriers to your learning will be a thing of the past. And you’ll get more value out of all your future learning experiences

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.mainsubjects.org.ua/article/12636/mainsubjects-Getting-Past-Major-Learning-Barriers.html">Getting Past Major Learning Barriers</a>

BB link (for phorums):
[url=http://www.mainsubjects.org.ua/article/12636/mainsubjects-Getting-Past-Major-Learning-Barriers.html]Getting Past Major Learning Barriers[/url]

“Mommy, Mommy, Mommy! Am I stupid?” excitedly requested Christopher, nearly out of breath from the long run into the kitchen. She knew he had been playing with neighborhood children under a mighty pine tree in the side yard. Saddened by the question and realizing he had just been tormented by the others, she tenderly gave him a hug and lovingly told him, “No, Christopher, you are not stupid.” “Oh,” replied Christopher, with obvious disappointment in his tone.

Even though Fed Chairman Alan Greenspan has pronounced the recession over, many businesspeople are taking about one thing only: survival. They are hunkered down trying to weather the storm, but they're doing it at the expense of building their businesses. And I believe many companies are unwittingly sacrificing their future.

Tags

Links

Main Subject - Getting Past Major Learning Barriers

Related Articles: