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Your Space - The Courage To Change
Autumn - crisp, cool nights and warming days; vibrant reds, yellows, orange and rust; a hot cup of tea and a cozy fire; a good book and the call of Canadian geese. These are autumn changes and they fill me with peace and joy. As Henry David Thoreau said, “Only that day dawns to which we are awake.” Wake up and look around you. We are in the mi
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
dst of change.
As I venture forth in Vermont during this time of year, I am amazed at the power of nature. It has the ability to heal, to rest and rejuvenate, to burst forth with new growth and to change its colors. It is the circle of life. I ponder my own circle of life. What changes have I made and do I have to courage to change some mo
As I venture forth in Vermont during this time of year, I am amazed at the power of nature. It has the ability to heal, to rest and rejuvenate, to burst forth with new growth and to change its colors. It is the circle of life. I ponder my own circle of life. What changes have I made and do I have to courage to change some mo
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
e?
Life is a journey, a journey to be enjoyed and I am going to embark on a journey right now. Do you have the courage to come along? I hope so and I hope this journey will be a catalyst of change for you and for me.
The journey of change… Let’s park the car and get out and walk. The sun is bright and warming
Life is a journey, a journey to be enjoyed and I am going to embark on a journey right now. Do you have the courage to come along? I hope so and I hope this journey will be a catalyst of change for you and for me.
The journey of change… Let’s park the car and get out and walk. The sun is bright and warming
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the day nicely. The air is fresh. Put on your hiking boots, as the ground is uneven and slick with the morning dew. Grab your backpack and let’s go!
Choosing a path… Shall we go this way or that way? Shall we choose our own path or follow someone else’s footsteps? You decide. Some times it is easier to trave
Choosing a path… Shall we go this way or that way? Shall we choose our own path or follow someone else’s footsteps? You decide. Some times it is easier to trave
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
down a trail blazed and well worn. Other times it is best to choose a new direction. Let’s stop for a moment and think about what we are seeking. Do you want to climb the mountain and enjoy the autumn scenery from above? Or, do you want to tread the valley along the meandering stream. Are you looking for peace and solitude or do you need th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
company of fellow hikers? Do you have the courage to choose?
Enjoy the moments… As we tread along, we are conscious of where we place our feet. The pathway is uneven with rocks and exposed roots that might trip us if we were not attentive. Periodically we need to stop to take in the view. We need to experience
Enjoy the moments… As we tread along, we are conscious of where we place our feet. The pathway is uneven with rocks and exposed roots that might trip us if we were not attentive. Periodically we need to stop to take in the view. We need to experience
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
the harmony of nature around us. It is a simple pleasure to watch the chipmunks scurry among the rocks, or lose our thoughts at the edge of a waterfall, or breath in the pine grove scents.
Think for a moment about your own life and your side journeys along the way. Too often we are focused on where we are placing our feet and fail to recogn
Think for a moment about your own life and your side journeys along the way. Too often we are focused on where we are placing our feet and fail to recogn
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
ze the pleasure moments. Too often we are spending a great deal of time taking care of all our stuff, our successes, our choices from the past and forget to look around at life’s treasures of the moment. Too often we are going through each day doing things by rote without even thinking about why we are doing them. We keep repeating old habits,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
getting the same results. Too often we fail to take the time to nourish our soul. Too often we miss opportunities.
If we did not slow the pace we would have missed the small flowers cascading over the ledges. We would have missed the call of the birds high in the branches. We would have missed the brilliant autumn display. What was the p
If we did not slow the pace we would have missed the small flowers cascading over the ledges. We would have missed the call of the birds high in the branches. We would have missed the brilliant autumn display. What was the p
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
int of this journey? We need to remember that it is the process, not the destination that is important. Do you have the courage to slow down?
The simple life… As we journey along our chosen pathway, we begin to notice the tension deep within our bodies slowly dissipate. We relax and breathe deeply transferring o
The simple life… As we journey along our chosen pathway, we begin to notice the tension deep within our bodies slowly dissipate. We relax and breathe deeply transferring o
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ygen into our cells. We feel a sense of peace and our perception of our environment changes.
Think for a moment about your daily schedule, the rat race on the highways, the pressures of success. Feel your shoulders tightening and your breathing become shallow? Now come back to our autumn journey and relax. Life is simpler here.
Our jour
Think for a moment about your daily schedule, the rat race on the highways, the pressures of success. Feel your shoulders tightening and your breathing become shallow? Now come back to our autumn journey and relax. Life is simpler here.
Our jour
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ney continues and we travel through thick wooded areas. We are glad we took a few moments to put some items into our backpacks. It is time to pull out the sweatshirt. It provides shelter in the coolness of the forest.
A little farther along we begin to notice light filtering through the trees. We sit in a patch of sunlight savoring the wa
A little farther along we begin to notice light filtering through the trees. We sit in a patch of sunlight savoring the wa
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
mth. The sweatshirt is no longer needed. We reach into our backpack for water and a nourishing snack. We packed well. We have what we need; we need what we have.
A journey of choices and changes… As we walk along harmoniously with nature I would like to pose another question for you to ponder. What choices and
A journey of choices and changes… As we walk along harmoniously with nature I would like to pose another question for you to ponder. What choices and
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
what changes could you make that would free you from anxiety. Pick just one and try it out. Do not rush the process. Take it one step at a time.
When I am working with clients who have the massive goal of organizing their whole life, the first step is to understand that one small change yields huge benefits. After all, in the autumn the l
When I am working with clients who have the massive goal of organizing their whole life, the first step is to understand that one small change yields huge benefits. After all, in the autumn the l
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
aves start to change gradually – a spot of red here and there, a blend of yellow and orange amongst the green. Nature teaches us that gradual changes are the easiest to bear. Do you have the courage to make small changes?
Our autumn journey has come to an end. Your journey has just begun. Here are a few thoughts to take along with you.
Our autumn journey has come to an end. Your journey has just begun. Here are a few thoughts to take along with you.
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
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
. Take a friend along ~ It is much easier to share the burdens and more fun to share the joys. The beauty of a rainbow is more spectacular when someone shares it with us.
2. Organize your supplies ~ If the sun is shining you may not need the umbrella. But do remember to take the sweatshirt, water and nourishment. It is important to provide
2. Organize your supplies ~ If the sun is shining you may not need the umbrella. But do remember to take the sweatshirt, water and nourishment. It is important to provide
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
for your physical, emotional and mental needs.
3. Vary the pace ~ There is a time to hurry along and a time to slow down. Knowing when to stop is as important as when to begin.
4. Take along a map or ask for directions ~ You do not want to tackle an unknown trail without some guidance. Seek out tips on how to make your journey light
3. Vary the pace ~ There is a time to hurry along and a time to slow down. Knowing when to stop is as important as when to begin.
4. Take along a map or ask for directions ~ You do not want to tackle an unknown trail without some guidance. Seek out tips on how to make your journey light
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r and easier going.
5. Change gradually ~ Over the years we have accumulate a lot of stuff. Let go of one or two things at a time until you reach a place that is manageable.
6. Take a rest ~ Brief resting along the journey will recharge your battery as well as give you an opportunity to enjoy the immediate environment. While you are res
5. Change gradually ~ Over the years we have accumulate a lot of stuff. Let go of one or two things at a time until you reach a place that is manageable.
6. Take a rest ~ Brief resting along the journey will recharge your battery as well as give you an opportunity to enjoy the immediate environment. While you are res
.
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
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
ting contemplate what your life is all about. Gaze inward, for that is where all the answers lie.
7. Choose the simple life ~ Simple living is simply finding and keeping adequate space and time for yourself, for those you love, for the place you live and for the work you do.
8. Pack wisely ~ Do you have all you need? Do you need all you
7. Choose the simple life ~ Simple living is simply finding and keeping adequate space and time for yourself, for those you love, for the place you live and for the work you do.
8. Pack wisely ~ Do you have all you need? Do you need all you
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
have?
9. Keep your heart light ~ Learn the value of laughter. It makes a world of difference.
10. Do you have the courage to change?
If you are interest in more information on the attitudes of organizing, please contact me through my website ~ www.OrganizingResources.com.
9. Keep your heart light ~ Learn the value of laughter. It makes a world of difference.
10. Do you have the courage to change?
If you are interest in more information on the attitudes of organizing, please contact me through my website ~ www.OrganizingResources.com.
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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