E-Folder - Business

TABLE OF CONTENTS

1. The Security Consultant's Perspective...

2. The Insider Threat...

3. Threats by the Outsiders…

4. The Terrorist Threat...

5. Protective Measures...

1) Security Consultant's Perspective...

Traditional techniques at combating Workplace Violence pits the disgruntled employee ag

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

ainst the system and the potential victims in a waiting game. It seems that the “Inside Threat” is reduced to monitoring the known potential, the “Ticking Bomb”, while the unknown threats go unmonitored. Threats by "Outsiders" are just as common and equally violent. Complicating this challenge, we now

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

Examples of combination products may in

ust grapple with the threat of terrorism (political and domestic) in our workplaces. I am reminded of a quote by James Baldwin from his book, "The Price of the Ticket". "No one can possibly know what is about to happen: it is happening, each time, for the first time, for the only time”. Fighting the po

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

ential workplace threat requires a change in tactics and training techniques in order to be proactive.

2) The Insider Threat...

The “going postal” employee is as real in many workplaces as was the case of the rash of Postal Service incidents that gave rise to the phrase by the media. The difference b

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

tween the postal employee and the ConAgra Shooting, Kansas (July 2004), the DaimlerChrysler Shooting, Ohio (January 2005) and the Weequaic High School Shooting, Newark, NJ (July 2005) North Toledo was the lack of sensationalized media coverage. I have found that career employees who “go postal” did not

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

Combination pro

plan to do so over night, nor was he predisposed to kill employees. It was a series of gradual events in the employee’s life brought about by changes in personal relationships, a diagnosed medical condition perceived unjust or a caustic domestic situation gone awry given rise to violence aggression as

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

a form of retaliation at home and the workplace.

The environmental, societal factors and contributing events could not have been more apparent to the trained eye. Perpetrators of workplace violence are victims of their environment because they did not plan their rampage the first day hired. It was a g

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

adual process with changes which bought about behaviors, attitudes and methodical planning clearly evident by the employee’s daily interactions, physical appearance, verbal utterances and documented slips in performance and efficiency. Everybody can see the indicators in the aftermath but most do not u

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

derstand how to collaborate to prevent the "Ticking Bomb" from exploding before it is too late.

The Threat Assessment Process though intrusive in some quarters is an instrumental process worthy of attention. Subtle but contributory changes in an employee’s demeanor can be detected with early warning s

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

gns to provide assistance and intervention. This response unlike the threat posed by "The Outsider” is manageable (predictable)and preventable.

3) Threats By Outsider...

Confrontational crimes committed by “Outsiders” though unmanageable can be mitigated and somewhat preventable. Take the following i

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

cidents. A nurse who works at a hospital who tells a horrific story of being punched, kicked, scratched, bitten, nose and ribs broken, stabbed with a pen and suffered eye damage all as a nurse at the hospital are true incidents. He also testified that patients have assaulted his co-workers. This accoun

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

Following aspects would a

represents one of several hundred such incidents at hospitals in our Nation yearly. A storekeeper who confronted an armed robber was shot because he did not have enough money. You stop your car at a client’s business and exchange what you need between the car’s compartment and the trunk and return to

dd to the challenges in developing combination products:

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

iscover the trunk broken into and the goods stolen? How about the lurking perpetrator who finds the pleasure in attacking helpless victims between floors on the stairwell or on the elevator? But nothing is worst than the unsuspecting medical service provider who is confro nted by a client in his home o

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

the office helpless to defend himself without any insight into appropriate protective measures.

These are situational accounts of innocent employees, victims of their unique situations created by their workplace environments and the threats posed by "Outsiders".

4) The Terrorist Threat...

Though mu

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

h attention has been given the political terrorist, little is mentioned in the workplace about our homegrown terrorists. The political terrorist who assimilates into the fabric of America to await the “call to arms”, is much different than the “normal” employee who harbors outward political, social an

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

religious positions but, is protected by freedom of speech that permits the employee to maintain antithetical positions for the safety and security of the workplace. Our workplaces are full of ideologies that spawn terrorism; Para-military and militia groups, white supremacist groups, black hate grou

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

Professional from academic institutions, pharmaceutical industries, health care indust

s; those who believe in extreme defense of the unborn, even environmentalist who work on the fringes of the law have spawned eco-terrorists, defenders of animal rights have attacked furriers and researchers and religious sects have spawned “holy warriors” who attack commercial and cultural interest. Si

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

ilar to both of these groups they choose targets of value and opportunity. Unlike the “Insider” and the "Outsider", the criminal behaviors of the domestic terrorist advertise their moves and are predictable because they are known and apparent.

5) Proactive Measures...

In no particular order: Train y

.

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

ur leaders in Threat Assessment, Synchronize the security process with other departments, Structure personnel security procedures, Design a unique security policy, Plan and Test your emergency evacuation plans, implement strategy to prevent and interdict workplace violence by all, Limit & restrict acc

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

Companies that provide selfless information through particip

ss, Issue a suitable form of identification with photograph, Teach crime prevention and have desktop exercises and scenarios, test your crisis communications plan, run periodic background checks on all employees and establish a repoting policy to encourage early identification of potential perpetrators

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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