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Advice You - Turtles Deliver the Internal Mail
The Corporate Events Manager at a leading high tech firm r
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
equested one of my demonstration videos.
I sent it prompt
I sent it prompt
; 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
ly by Federal Express. Later, I checked the FedEx website
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
(www.fedex.com) to track progress. The site provides insta
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
taneous information, telling me my package was delivered a
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 9:27 am the very next day. Two days later I sent an e-ma
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
il to the manager, asking for her feedback on the video.
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
‘I haven’t received it yet,’ she wrote back. ‘We have Turt
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e Mail inside this company. I should get your package by 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
he end of the week.’
Amazing! Federal Express picks up, d
Amazing! Federal Express picks up, d
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
elivers and tracks packages at warp speed…but inside this
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
Fortune 500 company, the mailroom can’t route an express p
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
ckage to the right desk within 48 hours!
Key Learning Poi
Key Learning Poi
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
nt
From satellites to sanitation, the need for speed appl
From satellites to sanitation, the need for speed appl
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
ies. What's the slowest part of your organization? Check i
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
t out, then speed it up!
Action Steps
Audit internal res
Action Steps
Audit internal res
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
onse times throughout your organization. How long does it
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
take to route a package, reply to an e-mail, return a voic
.
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
e mail message? Identify bottlenecks that slow you down. D
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
evelop ways to speed things up and implement the solutions
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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