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Have you ever made a mistake in business? Perhaps something silly that has a consequence to your client … How do you ad

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

mit the error to your client and still come out looking good in their eyes?

I recently received a phone call from a busi

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

Examples of combination products may in

ess associate and good friend – let’s call him ‘John’. He is a Financial Planner, intelligent, very good at his job, very

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

conscientious and caring.

“Linda, I need your advice … I have done something really stupid” he says. John had met with

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

new clients, several days before, for their initial Financial Planning session. This session lasted 2-3 hours, mountains

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

Combination pro

f important information is gathered which allows John to start creating their Financial Road Map.

“The file is lost!” Jo

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

hn says. “I have turned the office upside down; I have checked with every planner in the company; searched my car, the bi

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

s, everywhere … 3 hours of work and important information is missing and I can’t progress work for the clients without

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

it. What should I do?”

It was time for John to learn how to eat Humble Pie …

HOW TO EAT HUMBLE PIE

Act Promptly The 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

oner you take action the better your clients will receive the news. It is tempting to wait in the hope the problem will m

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

gically disappear … 9 times out of 10 it doesn’t!

Be Honest Mistakes happen to everyone. Be totally honest with your cl

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

Following aspects would a

ients about what has happened and the consequence. Honesty breeds respect.

Have a Plan Have a plan to rectify the mista

dd to the challenges in developing combination products:

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

e before you speak to your clients. It affirms your professional integrity and helps them feel they are being looked afte

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

r.

Add Value This is a great time to offer a service or product to your client that provides added value. You made a m

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

stake; there is some cost or consequence for your client. Adding value is a sign of acknowledging the inconvenience cause

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

for your client.

Be Gracious Your client may be upset initially about the mistake. That is understandable … Accept th

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

Professional from academic institutions, pharmaceutical industries, health care indust

eir reactions graciously – they will pass.

So John went back to his new clients and ate Humble Pie. The new clients were

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

very understanding and scheduled a time to redo the 3 hours of work.

By eating Humble Pie John had shown his clients he

.

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

was honest and committed to doing a great job for them. John learnt that eating Humble Pie was not as hard as he expected

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

Companies that provide selfless information through particip

it to be.

48 hours later the file reappeared – the work didn’t have to be redone after all! Funny how the world works

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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Expense Report Management is the process of managing the entire procedure of filling, submitting, approval, reimbursement and analysis of travel-related expenses of employees. Thus, expense report management includes four activities namely reporting, reimbursement, compliance and analysis. Reporting includes the process of preparing the expense report form, its submission to the concerned approval authority and obtaining all the management approvals for claiming reimbursement. Generally, most companies provide an online facility to their employees for completing the expense report form.

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