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It used to be that only the largest multi-nationals needed a Compliance Officer. Today most practices, regardless of size, would be wise to charge someone within their organisation with the responsibility of keeping abreast and managing the compliance process.

Take as an

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

example European employment law that has been introduced over the last few years that has changed the face of European businesses. Small businesses in particular are finding that a casual and informal approach to employment issues can now result in statutory fines that have no b

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

Examples of combination products may in

aring on the financial health of the individual company and could, without as much as a by your leave, directly result in the demise of a company.

Small to medium businesses do not often have the luxury of employing a full time Compliance Officer and although larger organ

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

isations can afford a dedicated person they are finding that with compliance issues mushrooming the Compliance Officer now has a team, a department and if not already, how long before compliance becomes a division?

Regardless of size, the first step in compliance for any

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

organisation requires them to identify the areas of compliance that are applicable to them. Rules and regulations are being introduced monthly on a local, regional, national and international level, covering everything from data protection and freedom of information, anti-money

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

Combination pro

aundering to environmental waste control, race relations to health and safety; with ignorance being no defence there is a requirement on the individual businesses to know their responsibilities, and fines for those that wait to be told.

Having identified the areas of com

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

pliance the company then needs to understand what they need to do to ensure they comply. It is becoming conceivable that with the shear volume of compliancy issues that companies who can show a good faith effort in complying will, even when they fall short, reduce the risks of f

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

nes.

Having identified and understood the compliance issues the Compliance Officer needs to define and implement policy and disseminate the information throughout the organisation.

It is important for the Compliance Officer that they do not inadvertently become the

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

company's patsy. Senior managers are not averse to ignoring the internal memos they receive advising them of their responsibilities. Compliance Officers need to deliver their messages up and down the corporate food chain and record that their advice and directives have been rec

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

ived and more importantly understood.

The Compliance Officer has to avoid becoming the company scapegoat. This won't happen by itself, a sales team that has a long history of success though a relaxed attitude to selling is not going to willingly adopt new, and what they w

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

ll see as restrictive, practices without a fight. 'I didn't get the memo', 'I didn't understand it', 'I thought it meant something else', 'I thought these were only guidelines' are likely to be stock replies, along with the one or two old timers that didn't think compliance issu

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

Following aspects would a

es applied to them. It used to be a safe bet to blame IT, blame Compliance is rapidly taking its place.

One valuable tool in the Compliance Officer's tool box is the online survey and questionnaire.

The online survey can deliver a message internally to the individu

dd to the challenges in developing combination products:

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

l; it can be informative like a memo and educational by referencing detailed policy. Importantly it can become a valuable self registering record that confirms that the information has been properly disseminated and understood.

A single survey question can achieve all the

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

se objectives at the same time.

Take an example:-

Are you aware that section 45 of the Companies (Auditing and Accounting) Act 2003 imposes an obligation on directors of certain companies to prepare statements on their company's compliance with its relevant obli

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

ations?
(Click here for a summary of Company's Policy on Compliance Reporting Obligations)

Yes
No

For those Directors that have not read the policy the survey will give an opportunity to view the company's policy online (using an embedded live HTML link)

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

Should Directors answer 'No' the Compliance Officer knows who to target.

The survey also records the manager's response and shifts the responsibility away from the Compliance Officer to the individual manager where the responsibility needs rest for a company to meet its

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

Professional from academic institutions, pharmaceutical industries, health care indust

compliance obligations.

Using an online website such http://www.surveygalaxy.com where multiple surveys can be managed, easily modified, updated and re-issued on a periodic basis across an organisation online surve

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

s can be the Compliance Officer's killer application.

Through the regular use of online surveys the Compliance Officer will be in the driving seat, leading and not chasing compliance issues, not only circulating the information on a one to one basis but also monitoring an

.

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

d recording the level of awareness throughout the organisation.

The Compliance Officer's role is a difficult one, like a parent keeping a wayward child on the straight and narrow, most employers, let alone their employees, often do not fully understand the true consequenc

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

Companies that provide selfless information through particip

of their, often innocent, minor discretions. Assigning a Compliance Officer is a start but enabling them to fulfil their remit will be the difference between a company being fully compliant and one that risks suffering the consequences for having let compliance take a back seat

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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Sit down and think long and hard about the problems people in society face. Think about the problems our communities as a whole face, and try and determine what the probable causes of these are.

Those who love to write and have a head for running a business should seriously give it a thought. Running a print newsletter can be fun and can also rake in the money, if that is what you love to do.

A recent “New Employer/Employee Equation” survey by Harris Interactive, Inc. conducted for Age Wave, took a broad look at the American workforce and found some less-than-encouraging attitudes towards work.

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