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E-Folder - It's a Lose-Lose-Lose Situation
One customer complained when served by a ‘Trainee’ at a five-star hotel. If
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
served by someone not entirely qualified, he wondered, should he pay a less-
; 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
han-qualified rate?
I think ‘Trainee’ badges are horrendous. They are frequ
I think ‘Trainee’ badges are horrendous. They are frequ
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ntly old and mangled, handed down from new staff to new staff for years.
Th
Th
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
new staff feel exposed and humiliated, as if they do not warrant a real nam
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
until they prove their mettle on the front line. The customer feels uncerta
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
n and wary, wondering if his requests for service will be understood and act
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
d upon correctly. And the manager is anxious, hoping a recycled plastic badg
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
will provide some defense or insurance from customer upsets and complaints.
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
Just the opposite often happens. The staff, manager and customer are all on
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
edge. It’s a ‘lose–lose–lose’ situation.
Instead, train your new staff to w
Instead, train your new staff to w
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
elcome customers with solid eye contact and a warm smile while saying:
‘Hel
‘Hel
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
o! It’s good to have you with us today, and my pleasure to serve you. I’m st
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
ll a bit new here so my colleague will be overseeing my work to be sure we 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
ke care of everything just the way you want it. Is that alright?’
Most cust
Most cust
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
mers would be surprised by such confidence from a new staff and are likely 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
respond, ‘That’s fine!’ And if the service is good, positive compliments wi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
l surely follow.
Key Learning Point
`Trainee' badges don't help; they only
Key Learning Point
`Trainee' badges don't help; they only
.
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
hurt and hinder.
Action Steps
Don't create anxiety with an old piece of pl
Action Steps
Don't create anxiety with an old piece of pl
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
stic. Instead, build confidence and goodwill with the right kind of training
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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