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Roles & responsibilities of a CPO
To advise, discuss, & implement effective safety procedures & ensure the protection of your client. It is my responsib

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

ility to make sure my client is safe.

Threat & risks assessment

To assess your surroundings & evaluate possible threats from suspicious individuals or

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

Examples of combination products may in

large groups, to plan ahead & make backup plans in case of an incident. (Escape routes)

Surveillance awareness
To observe & investigate a target throu

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

gh the use of CCTV, or first hand observations, use knowledge of body language, reactions, attitude & behaviour.

Operational planning
To make sure you

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

have the required operatives to cover the clients needs, ensure all CPO are fully briefed, to get a layout off the venue or route, equipment is working & av

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

Combination pro

ailable.

Law & legislation
I have the write to use reasonable force to protect myself or someone else if I feel myself or another’s life is in danger,

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

and will use reasonable force if necessary.

Interpersonal skills
Work as a team, communicate affectively on an even level, and listen to others to make

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

an informed decision.

Close protection teamwork
(TEAMWORK) is paramount as someone’s life may depend on it, as an individual we all have strengths & w

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

eaknesses, but if we work together the strength will be in the team.

Reconnaissance
To check out the area, route, venue, to gather intelligence & to ge

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

t a feel of the area & what plans to put in place.

Close protection foot techniques
Tripping, keeping a door closed, blocking,

Route selection
To

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

choose a route that is safe unobstructed & preferably planed, as to ensure the clients safety at all times.

Close protection vehicle techniques
To giv

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

Following aspects would a

e the client a safe means of escape into the vehicle, making sure the client does not get hurt due to our negligence, (hitting head on roof of car, door not

dd to the challenges in developing combination products:

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

opening quickly enough, making sure other doors are secured, and a safe speedy getaway.

Search procedures
have a whiteness, Make sure you have room to

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

move, make sure the person you are searching is not facing you, and start from the top moving down checking hats, shirt collar, under arms, wrists, pat down

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

pockets, belt, top of trousers, ankles & shoes or boots if necessary.

Incidents & dilemmas
There is always the possibility of something going wrong, i

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

f you have done all you can to prevent an incident & a dilemma still happens, then to be able to make reports, learn from the experience & use it to your adv

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

Professional from academic institutions, pharmaceutical industries, health care indust

antage, and try never to let it happen again.

Venue based security
Liaise with security remembering they will know more about the venue than yourself,

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

brief them on your priorities & that the client comes first in all matters.

Communication & conflicted management
Communication is of most importance,

.

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

if your colleagues do not know what you are doing you will be setup to fail, avoid confrontations at all costs; this will help you concentrate on your main o

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

Companies that provide selfless information through particip

bjective which is your client, if it looks like your client may get involved diplomatically or forcefully if necessary remove him-her from the situation ASAP

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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