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Advice You - Online Training on Autopilot Series... Persuasion Through Influence: PART 4 of 4
When you have the right systems in place, every element of your business and organization runs much more smoothly a
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
nd is much more effective.
I’m a believer in a systematic approach to everything. I define a “system” as a pro
I’m a believer in a systematic approach to everything. I define a “system” as a pro
; 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
vable, reliable method, tool or set of actions that provide me with a solution to a problem or job function.
O
O
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
course, every system I use, I’m able to adjust my level of input and “hands on” requirements as needed. There is
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
always a bit of tweaking involved to get them to do exactly what it is I need them to do, but when everything is ju
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t right – hallelujah!
When I can spend more time with my family and friends and know that my “system” is handling
When I can spend more time with my family and friends and know that my “system” is handling
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
things for me as well – then I have the perfect situation.
When incorporating a system to do work for you, whether
When incorporating a system to do work for you, whether
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
it’s to fill in a gap or take over a function – the system must be “flexible”. When I say flexible I really mean
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
o say that anything too “rigid” in life is not a good thing. Keeping a sense of flexibility, keeps you and your 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
ganization loose. If you need to make a few adjustments, then they need to be easy to do. If you need to make a c
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ange to your system and its like “reinventing the wheel” every time to do so – dump the system.
When you look for
When you look for
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
an online training system that can do right by you.. consider one that can automate as much as the administration a
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
s possible, as well as deliver your course material in a way that can engage your students.
When you influence you
When you influence you
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
employees using the power of automation and with rich-media, audio/video presentations that “engage the senses”, t
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
he information is recorded at a much faster and higher level and is continually reinforced (automatically) accordin
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
to your timing plan.
When you can train your employees on autopilot.. a trainer’s life becomes that much easier t
When you can train your employees on autopilot.. a trainer’s life becomes that much easier 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
o manage. When you can devote more of your time to the functions and goals that really matter to you, your empl
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
oyees and your organization.. you create more value for yourself and training as it relates to a core business func
.
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
ion.
Let’s face it, when budgets are tight – training seems to be the first thing to go or pay a price. By pu
Let’s face it, when budgets are tight – training seems to be the first thing to go or pay a price. By pu
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
tting systems in place and leveraging technology.. you position you and your department for success.
George Ritacc
George Ritacc
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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