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Digg It - Sarbanes-Oxley Compliance - Making Your Company More Accessible
The U.S. federal Sarbanes-Oxley Act was created to protect investors by improving the 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
ccuracy and reliability of corporate disclosures. The act covers issues such as establi
; 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
shing a public company accounting oversight board, auditor independence, corporate resp
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
onsibility and enhanced financial disclosure. The act came after a series of financial
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
scandals, including those affecting Enron and WorldCom.
Sarbanes-Oxley compliance may
Sarbanes-Oxley compliance may
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
be difficult for your company to adhere to at first, but in the long run it can be bene
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
ficial for you and your employees. Sarbanes-Oxley compliance will make your company’s f
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
nances more transparent and easier to navigate, as well as easier to tell when things a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
re not right.
In order to achieve Sarbanes-Oxley compliance a company must have a syst
In order to achieve Sarbanes-Oxley compliance a company must have a syst
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
em where information is accessible and manageable. Often times companies lose track of
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
important information and may be unaware of its whereabouts. This information is very i
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
mportant and may be contained in documents that have been lost in email or even inside
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
the hard drives of company equipment. In order to solve this problem a company must hav
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
e a system to manage this information to pass along in these corporate disclosures.
No
No
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
a problem, there is now an answers on how to maintain every document created by worker
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
s. NextPage has created a solution that will manage documents and allow a company to kn
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
ow exactly where information is stored, when it is changed, and its location at any tim
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e. With the help of this software every company will be able to meet the Sarbanes-Oxley
.
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
compliance in passing over correct information at the times that is needed. Whether a
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
company chooses to pass along the correct information is a completely different problem
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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