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Main Subject - Management Accountability, A Guide To Making Major Changes At Large Companies
I was speaking to my brother Sam, a partner in a CPA firm, about a mutual client requesting a “what to
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
do” regarding profit missing… theft. I had delineated the obvious controls missing previously, settin
; 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
g up procedures to prevent further theft, but again, they requested “what to do”.
They wanted some ki
They wanted some ki
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nd of list or report. Beyond “fix it”, the client didn’t understand that the question was, in fact, 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
e problem.
Management of the troubled company never recognized the real problem (or if they did, they
Management of the troubled company never recognized the real problem (or if they did, they
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
either ignored it or didn’t know how to fix it). They believed that implementation answers lie in a b
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
ook…or worse…a report, not in a process of changing themselves!
I remember years ago reading a book b
I remember years ago reading a book b
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
y the name of “Reengineering the Corporation”. It was a case study, “how to” book on changing
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
process in a company. The book was immensely popular. However, within 2 years a second book came out
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
entitled “Reengineering Management”. Changing people and processes hadn’t worked as envisione
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
d because management hadn’t changed the way they see and act daily!
It’s been my experience throughou
It’s been my experience throughou
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
t my 30 plus years of working with management as a CPA Consultant is that nothing ever changes unless
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
senior management is held accountable for the changes.
Accountability by definition is:
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
>the state of “being obliged to account for one’s acts; being capable of being accounted/responsible”<
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
/blockquote>
The word “account” means to determine, reckon, or measure, thus management must be subje
The word “account” means to determine, reckon, or measure, thus management must be subje
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
ct to discipline - and reward - if what they do is done properly.
If management won’t do what’s neces
If management won’t do what’s neces
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
sary or isn’t held accountable nothing will be accomplished. Thus management must be changed physicall
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
y or by process in those circumstances… even the operational role of a privately held company owner.
.
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
Leadership of the company must have the continuing WILL to change and be better for their revenue grow
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
th, profit goals, customers, and retention of good and valued employees in order to assure that result
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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