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Just Answers - Mine Your Life Experience
Few speakers know this. Fewer act on it. They want to know you. They want to know what makes you tick. What makes you so smart.
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
How you got to be up here at the head of the room.
What matters to you. Why it matters. What deep beliefs you cherish. What crucibl
What matters to you. Why it matters. What deep beliefs you cherish. What crucibl
; 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
s you’ve endured. How you survived. The lessons you learned. How they can steer clear of such crucibles while learning these life le
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
sons from you.
The challenges you've faced. How you overcame these challenges. Your strategies and tactics. The pratfalls and pitfa
The challenges you've faced. How you overcame these challenges. Your strategies and tactics. The pratfalls and pitfa
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ls you’ve endured. They long to laugh with you as you recount the red-faced moments of your life.
Your survival strategies, how you f
Your survival strategies, how you f
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nally got it together
and how they can get theirs together too. How you healed yourself from life’s wounds. How you shield yourself
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
rom the malevolent forces abiding on this planet. How they can do so, too.
Your principles, your North Star, how you decide what you
Your principles, your North Star, how you decide what you
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
ill and will not do as you move through this one-way ticket to life.
And where you got those principles and why you made them yours.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
hey might even welcome a word or two from your mouth regarding ideal principles they might engage and live by.
Your values and where t
Your values and where t
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
ey came from. Why they are your values and how clinging to these values adds value to your personal life experience. And what exactly
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
are ideal values anyway and what makes them ideal.
Your standards, and how they became your standards. The rationale for your standar
Your standards, and how they became your standards. The rationale for your standar
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
s. And the significance of setting standards for yourself. And what are desirable standards and who says so.
The crucial questions
The crucial questions
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
f your life and how you choose to respond to them. This leads to the crucial questions of all lives and the outcomes of different resp
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
nses.
Your purpose in doing what you do. And what makes purpose so important and why.
Your philosophy (You didn’t think I’d miss th
Your purpose in doing what you do. And what makes purpose so important and why.
Your philosophy (You didn’t think I’d miss th
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
t one did you?).
And from whence it came. And why it matters.
OK, OK, I know what you’re thinking. What happened to my topic, Burt,
OK, OK, I know what you’re thinking. What happened to my topic, Burt,
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
what happened to why the client pays me to be here?
You deliver your topic insights 100%. All the rest is the counterpoint. It’s t
You deliver your topic insights 100%. All the rest is the counterpoint. It’s t
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
e obligato. It’s the white space. Master speakers deliver a cornucopia of this relief in between the lines.
This means you actually
This means you actually
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
eliver 2 programs in 1: The program they pay you for and the program sharing the essential you. All of the second program is shared a
.
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
asides, off the cuff words, counterpoint, obligato, and white space.
Finally, you don’t have to do this all in one program. You shar
Finally, you don’t have to do this all in one program. You shar
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 here, some there. Some now, some the next time. What matters most: Be the authentic you as you reveal yourself to each audience
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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