Your Space - Self Improvement

Wouldn’t it be nice to live your life effortlessly and with ease with few, if any problems showing up on your radar screen? Would you like to learn how to enter the “probl

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

em free zone”, a place where you have plenty of time and energy to do what you really want without being constantly bogged down with sticky problems to fix? Thought you mi

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

Examples of combination products may in

ht be interested!

I daresay it is possible to experience the problem free zone. Really! And, no you, won’t have to isolate yourself from humanity so you can create more

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

armony and synchronicity in your life.

At a coaching conference held in Indianapolis several years ago, I heard Thomas Leonard, founder of the coaching industry make a bol

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

assertion. Thomas said, we, alone are responsible for the majority of problems we experience in our lives. Wow! He also coached us to take responsibility for our lives

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

Combination pro

nd adopt new strategies to eliminate and/or significantly reduce the number of frustrating, time consuming problems that were shoeing up in our daily lives. If you dramati

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

ally reduce the number of problems in your life, you auto automatically give yourself a reserve of energy, which you use towards those activities that inspire, motivate and

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

give you joy. For me this idea of living in the problem free zone was an absolute revelation! I was on the edge of my seat as I listened intently to learn this skill set.

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

I couldn’t wait to free myself and my clients from the tyranny of constant problem solving. Here’s what I have come to discover after learning this life changing notion:

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

First, in order to reduce or eliminate problems I your life, you must be willing to change and have an open-mind. Are you willing to take a good look at what habits you ha

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

e that actually create static for yourself? Here are three main ways that we create problems for ourselves:

A) Need for Control- Are you in the habit of forcing certain

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

Following aspects would a

utcomes? Do things have to be your way? Issues of gridlock and ongoing power struggles with others are probably your experience. Do you notice that you tend to the same

dd to the challenges in developing combination products:

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

ind of problems over and over again? There’s a reason for that!

B) Self Sabotage- Because of lack of confidence and self-doubts we may stall on taking action OR inadvert

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

ntly make mistakes that keep us occupied rather that accomplishing the actual goal. You may feel like you are spinning your wheels. Sound familiar?

C)Expecting the Worst

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

Do you think that life is hard? No pain, no gain? These beliefs are actually quite pervasive is our culture. Collectively we tell each other and ourselves that say not

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

ing is easy. This negative philosophy actually becomes a self-fulfilling prophecy. Your expectation of difficulty will be there every time, guaranteed. If your expectati

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

Professional from academic institutions, pharmaceutical industries, health care indust

n is that something is going to be hard to accomplish and that there will be lots of obstacles to achieving the goal. Trust me, it will be exactly that!

So let’s turn all

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

this negativity around, shall we? We live in an incredible time in history. We have access to so many types of resources from all around the globe. The truth is that for

.

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

most problems there are solutions. The Internet has contributed hugely in this regard. If you want fewer problems, then first make the assertion,I am a solution magnet! A

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

Companies that provide selfless information through particip

opt the mindset from here on out that any problem you have is masquerading as an opportunity for you to learn and grow. The solutions are readily available to you,I promise

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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