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Digg It - Business Continuity and Payment Systems
The Bank for International Settlements definition of a payment system states; “A payment system consists of a set of instruments, banking procedures and, typically, interbank funds transfer systems that ensure the circulation of money” (Fr
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
om “A glossary of terms used in payments and settlement systems”, Committee on Payment & Settlement Systems. BIS, Basel. March 2003).
Despite this we often associate the word “system” with only the technology; the bits and bites, the hard
Despite this we often associate the word “system” with only the technology; the bits and bites, the hard
; 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
are and the software. We tend to forget that there is a lot more that goes into making up a payment system.
A further problem is the user’s perspective, and in the case of a bank this is often from that banks own point of view – a view th
A further problem is the user’s perspective, and in the case of a bank this is often from that banks own point of view – a view th
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
at only concerns the bank itself. The outside world is seen as exogenous to the bank’s “system”. This is often the view taken when considering such critical issues as disaster recovery and business continuity planning. What is often overlo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ked is the big picture – the users, the clearing system and the settlement agent.
This total picture is something that was very clearly illustrated in the effect that the events of 9/11 had on the payments system in the United States gene
This total picture is something that was very clearly illustrated in the effect that the events of 9/11 had on the payments system in the United States gene
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ally, but more specifically in lower Manhattan. The aftermath of the 9/11 events clearly illustrated this - that disaster recovery and business continuity planning had been too focused on single localized events and assumed that all the ot
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
her system components would remain intact.
The major lessons learned were;
• Business continuity planning failed to take into account the possibility of wide-area disasters and for the major loss of or inaccessibility of critical staff.
The major lessons learned were;
• Business continuity planning failed to take into account the possibility of wide-area disasters and for the major loss of or inaccessibility of critical staff.
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
At many organizations contingency planning had generally concentrated on problems with a single building or system. Some firms maintained their backup facilities in nearby buildings, assuming that an “event” might debilitate or destroy a s
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ingle facility. Very few firms planned for an emergency that would disrupt whole business district or city. This led certain firms to loose access to both their main and backup facilities following 9/11 attacks. Generally firms had also no
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
considered the possibility that transportation of staff could be significantly disrupted and that their ability to move personnel to an alternative location would become extremely difficult or impossible.
• The market and geographical fo
• The market and geographical fo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
us intensified the effect of operational disruptions.
Those financial institutions that were significantly concentrated within the geographic area in New York City were most affected by the devastation at the World Trade Center. This was
Those financial institutions that were significantly concentrated within the geographic area in New York City were most affected by the devastation at the World Trade Center. This was
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
made worse by the fact that some had consolidated their staff in one or two locations for efficiency purposes. Certain critical market functions, especially in the clearing and settlement of funds, securities, and financial contracts, depe
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
d on a small number of specialist organizations each with their own operations in a concentrated area. There were major weaknesses in telecommunications capabilities because of these concentrations. Many firms believed they had full redund
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
ancy in their communications systems because they had arrangements with multiple telecommunications providers or because they had contracted for diverse routing, only to discover that all of the communication lines traveled through any of
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
everal single points of failure.
• There was a strong interdependence among financial system participants irrespective of where they were located
While financial institutions situated outside the New York City area were affected to a muc
• There was a strong interdependence among financial system participants irrespective of where they were located
While financial institutions situated outside the New York City area were affected to a muc
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
lesser degree than were those inside it, many felt the effects of the disaster. Most financial factors lost the ability to connect to banks, brokers and other organizations in lower Manhattan. This blocked their ability to conduct busines
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
s and establish whether transactions had been completed as anticipated. Some customers were affected by actions of institutions with which they did not even do business, when funds or securities could not be delivered due to operational pr
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
blems at other institutions. The suspension of all commercial flights had serious implications for the clearing of cheques.
In the post-9/11 world there is a clear understanding that the financial system has many components, and they all
In the post-9/11 world there is a clear understanding that the financial system has many components, and they all
.
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
have to work. It is the big picture, not the narrow “own” view that has to be planned for.
Business continuity planning needs to be made far more robust. Revised plans should include the ability for a rapid resumption of critical operatio
Business continuity planning needs to be made far more robust. Revised plans should include the ability for a rapid resumption of critical operatio
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
s following the loss or inaccessibility of staff in at least one major operating site; or following a wide-scale, regional disruption. It is vital that all critical internal and external continuity arrangements are effective and compatible
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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