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But even if you have had your employees screened prior to them joining your work force you should still remain vigilant. Research has shown that

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

certain behaviour patterns can indicate that an employee is no longer competent or may even have ulterior motives.

Look for changes in;

Persona

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

Examples of combination products may in

l Circumstances
For example has an employee had any major or unexplained changes in lifestyle or expenditure?

Attitude To Colleagues
H

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

ave relationships with their co-workers changed at all, particularly when someone gets promotion, do they appear to be getting stressed or short

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

empered?

Performance
Have they been under performing recently, are they continually being late or having unrealistic excuses for persistent

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

Combination pro

absenteeism, does their behaviour suggest problems with alcohol or drugs?

Extreme Viewpoints
Are they expressing racist, religious or othe

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

r prejudicial comments, are they becoming unpopular with their colleagues, do they appear to be bullying or threatening to others?

Unusual Inter

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

ests
Do they have hobbies or engage in activities that appear extreme or unusual, or express interests that are distasteful to the rest of t

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

e workforce?

Extended Working Hours
Do they seem to be working long hours and reluctant to accept help from their co-workers, are they beco

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

ming secretive about their particular tasks, do they appear reluctant to take holidays or other breaks?

Attitude To Security
Have they chan

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

ged their procedures or processes without any obvious reason for doing so, has their level of friendliness to security staff changed, do they avo

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

Following aspects would a

id getting to know other members of staff?

Colleague Relationships
Have there been noticeable changes in social habits, have they begun to

dd to the challenges in developing combination products:

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

ithdraw from any particular individuals or groups of people?

It is important for all organisations to be aware of the dangers from outsiders, bu

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

t the real damage is so often caused by the people who are actually working within them. Your company may have excellent physical security and ul

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

tra modern access control systems, however professional criminals and extremists wishing to infiltrate and harm your business (known as ‘insider

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

threats’) are utilising methods to circumvent existing security procedures including;

Recruiting and implanting a ‘sleeper’ into your organisati

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

Professional from academic institutions, pharmaceutical industries, health care indust

n, and then activating them only when a specific task is required.

Targeting an existing member of staff, particularly if they spot any vulnerab

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

ility or weakness, by offering cash for sensitive information, or by threats of physical violence if they don’t comply.

Gangs have often comprom

.

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

ised company employees through drugs, sexual favours and other unsavoury inducements. It is only through consistent and organised vigilance that

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

Companies that provide selfless information through particip

these threats can be countered by company security officers, and only if they are kept up to date with actions and reactions of company employees

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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