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You’ve hung out your shingle and are ready for business. But what if something unforeseen were to occur? Is your business truly ready for all that being in business entails? It only takes one catastrophic event to adversely impact a once thriving business. Recent wo

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

rld events: 9/11 destruction of the World Trade Centers and the Pentagon, the tsunami in Asia, along with other natural disasters act as a constant reminder that being well-prepared is often our best line of defense.

What’s that, you say? Your business isn’t located in

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

Examples of combination products may in

a city likely to be a target of either natural or manmade disasters. This may well be the case, but this doesn’t take in account that inexplicable chemical spill or train derailment that can happen on your doorstep or public utility failures, such as electrical power ou

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

ages, brownouts or surges, which can unduly affect the daily operation of your business. Keep in mind, many nature disasters, such as blizzards, tornadoes and earthquakes, can strike with little or no advance warning.

So what’s a business owner to do? Well first, and

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

oremost, you make sure your business has an up-to-date disaster plan. It’s been reported that as many as forty percent of small businesses fail to open their doors again after a major disaster. Many of these businesses were simply unprepared for a disaster; they hadn’

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

Combination pro

taken the time to prepare a backup plan to better insure the livelihoods of their employees or the continued satisfaction of their customer base.

When you begin to develop your company’s disaster preparedness plan, three areas should be given special consideration: hu

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

an resources, physical resources, and business continuity. In devising a plan, as a business owner, you must carefully consider how a disaster might impact your employees, customers, the physical workplace itself, along with what procedures and policies would need to 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

in place to continue to conduct business if that disaster forces you to temporarily relocate to another site.

All Disaster Plans Should Consider the Following:

Human Resources

• Identify staff essential to your business keeping its doors open. Keep an updated list o

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

their contact information: phone numbers (home, work, pager, cell) and e-mail addresses that can be made available from several locations (home, Internet, etc.). This information should be readily available to key staff members.

• If your business has voice mail, sel

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

ct one remote number on which you can record messages to be accessed by employees in case of emergencies. Make sure that your phones can be programmed to forward calls from the main business line(s). This allows to you program the phones to ring at another site if you

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

annot access your business. Make this number available to all employees.

• Keep copies of personnel, payroll, payables and receivables, and other essential records at an off-site location.

• Leave copies of keys and alarm code(s) with a trusted employee or friend enc

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

Following aspects would a

se you cannot get to your office quickly after an emergency,

Physical Resources

• Install emergency lights that turn on with power failures. Relatively inexpensive, they can be purchased at electrical and hardware supply retailers. Back up computer data frequently;

dd to the challenges in developing combination products:

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

eep a copy of the tape off site.

• Use UL-listed surge protectors and battery backup systems to provide added protection for sensitive equipment and help prevent computer crashes if the power fails.

• Purchase a NOAA Weather Radio with a tone alert feature. Keep it o

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

and when the signal sounds, listen for information about severe weather and protective action to take.

• Stock emergency supplies, including: flashlights, batteries, First Aid kits, tools, and food and water to use during periods of unexpected confinement at your busi

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

ess.

• Install flexible connectors to appliances and equipment fueled by natural gas. Consider installing shutters to protect windows from damage caused by debris blown by hurricanes, tornados or severe storms.

• Install automatic fire sprinklers on each floor of the

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

usiness.

Business Continuity Resources

• Maintain a minimum supply of the goods, materials and equipment you would need for business continuity off-site.

• Be advised: most insurance policies do not cover earthquake and flood damage. Discuss business continuity insu

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

Professional from academic institutions, pharmaceutical industries, health care indust

ance with your agent to cover business interruption losses.

• Know how to contact law enforcement and local offices of the American Red Cross, Federal Emergency Management Agency and other agencies that can assist during a crisis.

• Devise an external/public emergency

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

communications plan that outlines how your business will communicate with the news media, customers, and vendors in the wake of a catastrophe.

• Contact vendors/suppliers to confirm their emergency response plan procedures. Line up alternate vendors for essential suppl

.

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

es and equipment. Have back-up equipment and know its availability during periods of crisis.

Your employees are just one in a line of several defense measures available to you. Everyone on your staff should be prepared for a disaster and know what to do if a disaster o

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

Companies that provide selfless information through particip

curs. Several organizations including the American Red Cross, Federal Emergency Management Agency (FEMA), the Institute for Business and Home Safety, and the Small Business Administration can provide you useful information about how to stay safe in instances of disaster

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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The town is geared towards the hosting of conferences since there are many held there at any given time. This has lead to Bournemouth being recognized as an important conference venue. Some of the most well known conferences to be held in the area include the annual conference of the Labour Party in 2003 as well as the annual conference for the Conservative party in 2006.

If you are looking for a career change that 'upsizes' your life then you need to be clear about who you are and what you stand for. It helps to have a great coach to work with at this point. Without a coach, you need to be asking yourself some searching questions about what you WANT to do, who you want to BE and what you want to HAVE.

Whilst some of the world's most successful corporations attribute their success to Lean Thinking – others who have attempted to emulate their success have been frustrated by a lack of progress. In this article we consider why 'going lean' is so difficult.

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