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People's views on business continuity planning vary from: "business..what?” "just common sense isn’t it?" "oh god where do we start!" So let’s bring these views into line with a simple l

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

ist of how business continuity planning can benefit your business:

# 1 Survival.

The harsh but simple fact is that there are a hundred and one things that can disrupt a business. A

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

Examples of combination products may in

well thought out, practical plan can mean the difference between coping with a disaster and going bust.

# 2 Revealing inefficiency.

A business under threat can be viewed like a patient on an

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

operating table. The priorities are clear; maintain the blood supply (like cash flow), oxygen (like communication links) and at all costs protect the vital organs (like the staff, or premises

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

.

Business continuity planning starts with a thorough analysis of the business to decide what parts are vital. Is that product or service really essential to what we do? Why do we need four o

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

Combination pro

those not two? When viewed like this the non-critical parts reveal themselves – all the procedures and resources that have appeared over the years but which aren’t really necessary.

# 3 Gain

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

ing the marketing edge.

Having a business continuity plan can give you the edge over your competitors. It shows your commitment to deliver no matter what happens.

Put yourself in your custom

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

r’s shoes - do you sign the contract with the business that has a business continuity plan? Or the one that doesn’t?

# 4 Boosting staff morale.

To find and keep excellent staff you need to i

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

spire confidence and maintain loyalty.

When something goes wrong they expect/demand the business to have a plan and to cope. In return they will give you their best efforts.

# 5 Keeping insu

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

rance premiums under control.

Insurance is an important aspect of addressing business risks but it costs. A robust business continuity plan will demonstrate your commitment to managing risks

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

nd your insurer should consider this when calculating how much your insurance premium will be.

# 6 Compliance.

The demand for business continuity plans is now rippling down from big business

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

Following aspects would a

to their smaller suppliers. In the UK one of the big supermarkets (Sainsburys) is starting to vet suppliers. Added to this legislation such as the UK's Civil Contingencies Act 2004 now require

dd to the challenges in developing combination products:

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

s category one responders (local councils, health authorities, police, fire etc) to ensure the business continuity arrangements of their suppliers.

# 7 Better communication.

A business conti

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

uity plan relies upon communication – being able to give the right person (who can fix the problem), the right info, at the right time. It’s also the ability to keep talking to customers, supp

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

iers and staff even if your office is a pile of rubble or just locked up and the key missing.

Normal, day to day business can surely benefit from better communication. Whether that's having a

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

wider range of tools at your disposal or becoming more disciplined at sending the right information to the right people.

# 8 Increased value.

A business that will cope with whatever is thro

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

Professional from academic institutions, pharmaceutical industries, health care indust

n at it is a more valuable and reliable investment than others. Ensure this is factored in when asking your bank manager for a loan, when selling some equity or dealing with the new owner when

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

you have decided to sell up and relax.

# 9 A negotiation tool.

Scientia potentia est - Knowledge is power. Understanding the principles of business continuity means you can spot wea

.

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

knesses in other businesses. If your main supplier is asking for a price increase ask about their business continuity plans. If you spot holes then ask why you should pay extra when there may

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

Companies that provide selfless information through particip

e more reliable suppliers out there.

# 10 Relaxation!

While other business people lie awake at night, you can rest easy knowing your business continuity plan is ready should the worst happen

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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