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In the wake of most catastrophes, the media often concentrates on tragic personal stories: lost life, lost homes, lost belongings, lost pets. But what about lost busin

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

esses? Medical facilities, law offices, corporate and government organizations—none are immune to the costly effects of flood, fires or hurricanes. Patient histories,

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

client, vendor and employee files, financial records, contracts… Businesses depend on the reliability and accuracy of these accumulated records. How could any organiz

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ation hope to rebound if so much information is destroyed? The long-term security of business documentation is imperative to the success of any organization, large or

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

small.

A 2006 report by the Ponemon Institute, a privacy and information research firm, found that each individual compromised or lost record averages a cost of $182 t

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

o companies. According to the study, company costs for each of 31 separate incidents analyzed ranged from less than $1 million to upwards of $22 million. These are co

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

mprehensive costs, including legal, investigative, and administrative expenses, stock performance, customer defections, opportunity loss, and reputation management.

Ma

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

nagers and leaders still operating under the motto “it won’t happen to me,” take heed; “it” can happen to you. However, the damage done can be seriously minimized by t

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

aking proper precautions and establishing disaster recovery systems. Your records’ integrity is vital to your organization’s success, and addressing system vulnerabili

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

ties is imperative to data preservation. Duplicating records on-site is no guarantee of their safety, and businesses ignoring new disaster recovery solutions seriously

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

compromise their future operability.

Remote mirroring, a new trend in the realm of disaster recovery, provides real-time, off-site data storage. Updates made on the

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

server are simultaneously saved to the mirror box, which can be hundreds of miles from the primary location. Even if the main computer is submerged or fried, a high-qu

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ality mirroring box will preserve 100% of the information put into the computer until the moment of the disaster. Data mirroring can save solutions on a range of stora

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ge devices, and is designed to be scalable to your needs as they grow and change.

Looking to the future is key, and education is the first step toward effective disast

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

er recovery planning. Speaking to experts, discovering your vulnerabilities and researching the solutions to address them are necessities. Attending information and t

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

raining sessions taught by industry specialists is a great way to learn without throwing money away. For example, Acolyst, a solutions provider in Fredericksburg, VA h

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

olds free seminars jointly with technical experts from other industry leaders, including MiraLink and CA—major players in the realm of disaster recovery. Attendees at

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

such events get exposure to cutting-edge technologies and personal consultations in a no-pressure-to-purchase environment.

While every business venture is a risk, igno

.

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

ring the possibility of catastrophe is a gamble that no responsible leader will take. Avoiding disaster recovery decision-making will damage your organizations’ prospec

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ts. Why threaten the success of your organization, and the security of people who rely on you? Take the initiative and learn about disaster recovery options near you.

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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Using an online registration system to register attendees for your next event can significantly diminish your workload and increase attendance, but automated follow-up by email is essential for the success of your event.

When a product is first launched into a market a firm will have to decide what price to charge.

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