Main Subject - Internet and Businesses Online

Effective information security within government Government departments can no longer afford to

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

sit back and allow security consultants to assess their risk levels. In addition to deploying sec

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

Examples of combination products may in

rity systems in order to ensure that the environment is secure, security consultants must also un

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

derstand what the bad guys (hackers) are doing, and test the systems on a regular basis, says Hug

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

Van Niekerk, specialized services director of Carrick Holdings. "Use the services of an ethical

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

Combination pro

acker, or get fresh eyes to test your system," he says.

Van Niekerk adds that organisations shou

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

ld also ensure that the solutions being deployed fit the risks that the organization faces so tha

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

they do not over-invest in systems, says. He advises that the CIO invite top technical staff to

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

the assessment meetings with potential security consultants, so that they can ask technical quest

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

ons as to the solutions that will be deployed. The information that comes out of the assessment

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

should be used to draw up a clear and clean service level agreement, he adds.

Haroon Meer, techn

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

Following aspects would a

ical director of Sensepost South Africa says while laying out the expectations in important in te

dd to the challenges in developing combination products:

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

ms of service level agreements, that the organization should not restrict the security company to

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

only use tactics that were previously agreed upon during the assessment stage. Max Melamed, info

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

mation security manager for Ernest and Young South Africa however cautions that organizations sho

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

ld not be too obsessed with detailed policy documents that outline information security measures.

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

Professional from academic institutions, pharmaceutical industries, health care indust

“Policies do not stop a hacker,” he says. The development of detailed policy documents also del

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

ys the implementation of security measures, he says. The human element should also be factored in

.

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

to information security measures that are taken, delegates.

"Government should do background che

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

Companies that provide selfless information through particip

ks in order to build a workforce that is not populated by white collar thieves," Van Niekerk says

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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