Useful Advices - Business

ISO 27001 calls for controls to be implemented on removable media to stop una

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

uthorised access and transmission of data. It is not unknown for a disgrun

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

Examples of combination products may in

tled employee to download data containing commercial information onto some fo

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

m of portable memory device just before leaving employment. This can be sens

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

itive information such as customer information, product information, designs

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

Combination pro

r drawings.

The compromise of these documents can be very damaging for the e

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

mployer. It does not matter that the employee has signed a confidentiality a

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

reement because the damage is already done.

Sensible employers who wish to p

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

revent data downloads can stop any transfer of data from a USB port or other

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

evice by incorporating this into the Computer Group Policy, installed from t

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

he network during boot up, thus disabling the USB port for this purpose; the

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

Following aspects would a

port can still be used for necessary functions, such as a keyboard or a mouse

dd to the challenges in developing combination products:

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

A less effective method would be to have a 'No USB memory stick' condition

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

in the Employee's terms and conditions, but this does need to be policed on a

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

regular basis.

I am constantly surprised that companies that are normally ca

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

reful with computer data have no firm policy on removable or portable memory

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

Professional from academic institutions, pharmaceutical industries, health care indust

evices.

I have spoken here about USB sticks but this applies equally to SD c

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

ards, iPods, etc. The relatively large capacity of these devices, often giga

.

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

ytes in size, does mean that a considerable amount of data can be downloaded.

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

Companies that provide selfless information through particip

Security of data must be extended to include portable memory devices.

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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Useful Advices - Memory Sticks - Sd Cards and Other Removable Media

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