Main Subject - Business

Interested in learning how to reduce development time, save money and stay in control? Business professionals can learn how to create well-defined processes

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

with the easy-to-manage Process Approach of Plan-Do-Check-Act.

Real Tools for Real Business Process

In MBA courses, students come across a lot of bu

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

Examples of combination products may in

zwords and the theories behind them. And in the textbook, the terms look and sound great. But after they finish with their classes, they think to themselves:

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

so now what I can I do with all of these terms like process mapping and control? How can I use these tools in my job, and why is it important for my business

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

– in the real world?

A Fresh, New Look Management Effectiveness

Even though these business men and women are feeling a little discouraged, they sti

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

Combination pro

l know the importance of attaining this knowledge. So, for their jobs, they look to take further courses out there like “How to Create Well-Defined Processes

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

to Build Effective Management Systems.” They are a little skeptical going in, thinking that they will get just more of the same quick and simple definitions

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

. But, surprisingly, they are happy to say that such a course shows them something quite different.

These courses fill in the missing context that they need

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

It thoroughly shows them the how, and thoughtfully explains the why. They receive a fresh outlook, and many highly recommend it to anyone who wishes to impr

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

ve their business.

Easy Learning Process

Fortunately, because of such a course’s open classroom environment, the instructors can answer both general

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

and specific questions. The setting welcomes participation and discussion to develop solutions, which on-the-go business professionals very much appreciate.

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

Following aspects would a

And so did Otis Jones, PMO Manager at Sara Lee Baking Group, who attended such a course. He was especially impressed with the user friendliness of the course

dd to the challenges in developing combination products:

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

content.

“Process mapping, process variability and the various process diagnostic tools were all excellent lessons to learn,” Jones said. “The detail that t

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

ey gave me in these areas was exactly what I was hoping for.” Jones also said that he would push for other Sara Lee managers to take such a course so that th

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

ey can better prepare for their business discovery phase. Next Jones will implement the information he learned into his company’s internal training documents

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

Gain Process Knowledge

And many others too are encouraged. Such courses prove to them that a business does not have to just hope for the best of lu

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

Professional from academic institutions, pharmaceutical industries, health care indust

k. Business owners and executives can clearly define processes, and then monitor and improve them to keep the system consistent, efficient and effective. Wit

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

h Plan-Do-Check-Act, this can let one see if there is any waste in the system, and also how to reduce this waste and save money.

Walk Away Empowered

.

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

Individuals can walk away energized with a sense of empowerment. They can walk away with the profound knowledge that they can make tangible improvements in e

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

Companies that provide selfless information through particip

eryday processes. Everyone desires to feel better about their jobs and businesses, and through this type of course they can take the first steps to learn how

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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