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Managing operational risks is a part of every business process. If we talk of banks, there are different ways to calculate the capital

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

charges arising out of operational risk. Let’s know them better.

Basic Indicator Approach: One of the ways is the Basic Indicator App

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

Examples of combination products may in

oach. Here, it is necessary for the banks to hold capital for operational risk. It is equal to the average calculated over a period of

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

hree years on a preset percentage of annual gross income that is positive. The percentage is usually 15.

This method does not call for

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

any particular criteria. However, banks adopting this method more or less abide by the Committee’s guidance on “Sound Practices for the

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

Combination pro

Management and Supervision of Operational Risk”. Its principles demand a practical approach in developing an environment that boasts o

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

appropriate risk management, constructive actions towards identifying, evaluating, supervising, and regulating the operational risk, a

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

d sufficient public disclosure.

Standardized Approach: This approach divides the activities of bank into eight business lines. Here,

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

he basic indicator is the gross income for each business line. It helps to know how big the operational risk is.

The summation of capi

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

tal charge is equal to a total of the regulatory capital charges for each business lines every year. It is calculated for a period of t

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

ree years. In case there is a negative capital charge in any of the year and in any business line, it may counteract positive capital c

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

Following aspects would a

arges for other business lines. In addition, there is no limit to it.

Advanced Measurement Approaches: The banks have to obtain a sup

dd to the challenges in developing combination products:

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

rvisory approval for using advanced measurement approaches. They have to prove that the method adopted by them is practical and effecti

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

ve. It is important that any method applied for measuring the operational risk must be in line with the standards and definition of ope

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

ation risk.

The following are the points on which the banks have to get the nod from the supervisor:
• The board of directors as

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

ell as the senior management is aggressively occupied with building the framework of operational risk management.
• The bank has a

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

Professional from academic institutions, pharmaceutical industries, health care indust

strong operational risk management system. It comprises of a separate operational risk management department that looks after the frame

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

work and the execution of the task.
• The bank has ample resources to apply advanced measurement approaches in all the chief busin

.

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

ss lines, the control areas, and the audit department.

The operational risk management strategies certainly influence the bank rat

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

Companies that provide selfless information through particip

ngs in the years ahead. Hence, it is important that the banks make an effort to adopt an effective operational risk management approach

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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The purpose of your promotions is to get more sales, not to soley enhance the image of you or your company. As a salesperson you must understand this right at the beginning or you will be wasting your's and every one else's time.

Why has selling become a dirty word? All the focus today seems to be on Advertising and Marketing, yet we still need to engage our customers in face-to-face persuasive conversation. Let’s take a look at the processes of selling and advertising and look at the links.

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