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Others - One Year Later: Surviving the Katrina Anniversary
One year ago, your life was turned upside down by Hurricane Katrina.
Now, one year later, you are facing the first anniversary of the disaster. You may be feeling nervous that another hurricane may blow through. Emotions brought on by
Now, one year later, you are facing the first anniversary of the disaster. You may be feeling nervous that another hurricane may blow through. Emotions brought on by
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
your losses may be coming over you in waves. It’s possible that your discomfort has grown each day as the anniversary approached. This article provides you with some tips to help you understand what you are experiencing and help you f
; 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
el supported during your anniversary.
What’s Happening to You?
First, let me explain that what you are feeling is documented and happens to many people who have been through a trauma or loss—especially one of the magnitude that you’ve
What’s Happening to You?
First, let me explain that what you are feeling is documented and happens to many people who have been through a trauma or loss—especially one of the magnitude that you’ve
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
been through.
Sometimes when you are going through something you don’t understand, it helps to have a name for it. What you are experiencing is called an “anniversary reaction.”
An anniversary reaction occurs when unresolved feelings
Sometimes when you are going through something you don’t understand, it helps to have a name for it. What you are experiencing is called an “anniversary reaction.”
An anniversary reaction occurs when unresolved feelings
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
and sensations are triggered by the anniversary and circumstances that are similar to those of the original trauma. This reaction occurs because you didn’t have the opportunity to feel or process your emotions at the time of disaster. Y
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
u were focused on surviving and didn’t have the time, skills, or capacity to feel all of the losses at that time.
Over the last month, as the anniversary approached, you may have felt discomfort, anxiety, and uneasiness in a lot of dif
Over the last month, as the anniversary approached, you may have felt discomfort, anxiety, and uneasiness in a lot of dif
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
ferent ways – physically, emotionally, mentally, and spiritually -- in your relationships, in your work, in your family. Please know that these effects will begin to ease up as you pass the anniversary date.
Plan for the Anniversary
A
Plan for the Anniversary
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
you read this article, think about how you want to spend the anniversary. What will be best for you?
Do you want to be on your own?
With your community?
With your family?
Do you want to spend time at a remembrance?
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
What you want/need may be different from what others in your family or
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
social circle want to do. That’s okay. If you feel you must join in a family activity, set up some time for an activity of your own choosing. Whatever you do, have compassion for yourself and those you love.
On the Day of the Anniversa
On the Day of the Anniversa
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
y
The day has finally arrived. It’s possible you are feeling a bit nervous about how the day will unfold.
• Work your plan for the anniversary. Although you have a plan, it’s possible that your feelings about what you need may have ch
The day has finally arrived. It’s possible you are feeling a bit nervous about how the day will unfold.
• Work your plan for the anniversary. Although you have a plan, it’s possible that your feelings about what you need may have ch
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
anged. If your needs have changed, make any necessary adjustments. There is no “wrong” way to honor the day. What’s most important is that you take care of yourself.
• Share memories and stories of event and those lost. Whether you spe
• Share memories and stories of event and those lost. Whether you spe
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
d time alone or with others, you might want to share your memories. If you are with others, talk about your memories. If you are spending time alone, you might want to write down your thoughts.
• Find a ritual to acknowledge the trauma
• Find a ritual to acknowledge the trauma
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
and how it has affected you. Rituals such as lighting candles, singing with others, standing in a circle in prayer can bring you strength. If one of these options doesn’t feel right, consider doing something that helps others – give bl
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
od, volunteer, or donate.
• Create new memories. One of the most powerful things you can do right now is to create new memories, rituals, or traditions. This is a wonderful process to do as a family or with a good friend. Think about s
• Create new memories. One of the most powerful things you can do right now is to create new memories, rituals, or traditions. This is a wonderful process to do as a family or with a good friend. Think about s
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
mething you can do together to create a new touchstone for the day.
• Create a physical memorial. For some, having a physical symbol of the event is helpful. They find solace in being able to visit a memorial, plaque, status, or sculpt
• Create a physical memorial. For some, having a physical symbol of the event is helpful. They find solace in being able to visit a memorial, plaque, status, or sculpt
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
ure.
• Acknowledge how far you’ve come. Although it’s unlikely your life is put back together again, honor what has improved for you--even if the progress is slight or subtle. Notice your physical status, how you are feeling emotionall
• Acknowledge how far you’ve come. Although it’s unlikely your life is put back together again, honor what has improved for you--even if the progress is slight or subtle. Notice your physical status, how you are feeling emotionall
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
, how you are feeling mentally, and how you are doing spiritually.
• Take note of the positive things in your life. Notice anything that brings a smile to your face—a young child’s antics, a pet, a flower, a beautiful sunset. Shifting
• Take note of the positive things in your life. Notice anything that brings a smile to your face—a young child’s antics, a pet, a flower, a beautiful sunset. Shifting
.
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
at least some of your energy to the small gifts of life can lift your spirits.
• Search for the gifts in your situation. Although you’ve been through an incredibly difficult year, it’s likely that in reviewing your year you’ll discover
• Search for the gifts in your situation. Although you’ve been through an incredibly difficult year, it’s likely that in reviewing your year you’ll discover
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
some unexpected gifts. You may notice your own strengths, the fact that you survived your trial, ways you’ve changed, or relationships that have strengthened as a result of the event.
Copyright 2006 Transition Dynamics Enterprises, Inc
Copyright 2006 Transition Dynamics Enterprises, Inc
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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