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Process of Proactive Detection of Fraud
1. Build the Proper Team
Regard

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

less to the total size of the team, there should be at least three specific experts. The first is a domain expert that

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

Examples of combination products may in

has an inside perspective of the industry and the business. The second is a technology specialist that is familiar wit

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

h the system being used by the company. Lastly there needs to be someone familiar with fraud and the symptoms involved

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

with it.
2. Team Must Develop an Understanding of the Business
Similar to any audit plan

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

Combination pro

a fraud investigation must be customized to the particular company being observed. All business are different thus th

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

ey clearly have differing areas of potential fraud. After identifying the different functional business areas the team

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

should walk through, talk with employees, observe procedures, review documentation, and other learning the business pro

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

edures.
3. Perform a Risk Assessment
Based on the understanding gained about the differe

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

nt areas of business the team should then evaluate those high risk conditions. By understanding the common risks they

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

re able to identify those symptoms that would appear in a fraud scheme in that area. In this step it is important to c

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

Following aspects would a

ntinually brainstorm about how employees could potentially commit fraud given the current control system.

dd to the challenges in developing combination products:

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

g>4. Clearly Define the Targeted Fraud Symptoms & Search for Them
In order to proactively detect these

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

isks it is important to identify those symptoms that would most likely reveal a case of fraud. To read more about the

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

dentifying risks please see the article 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

ms_of_fraud">Fraud Symptoms While searching for the symptoms it is important to collect company data and compile a

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

Professional from academic institutions, pharmaceutical industries, health care indust

list of suspicious looking transactions.
5. Investigate High Risk Symptoms
The most effi

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

ient way to investigate these symptoms is the use of computer analysis. By looking into only those risks that can not

.

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

be explained by further analysis the team is able to save time and resources. The identification of abnormalities at t

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

Companies that provide selfless information through particip

is stage will require much scrutiny during investigation and will be an high risk area when performing the annual audit

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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