Useful Advices - Business

An expense report is the statement covering all the expenses of official or personal travel of an employee that is to be submitted

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

to the employer for the purpose of reimbursement. Expense reports also serve the purpose of personal record of the expenses or fo

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

Examples of combination products may in

r accounting and tax payment preparation. The expenses generally include air/train fare, hotel accommodations, food expenditures a

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

nd other travel-related expenses. Often, the employees take too much time for the submission of expense report, but the process sh

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

uld be quick. The process of expense reporting can be made simple and quick only through automation with web-based expense report

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

Combination pro

management software like Expense Management Automation (EMA) and Ceridian Expense Manager.

With these programs, the employee subm

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

its the report online to the approval authority and faxes the receipts. Almost all the companies are following this method of auto

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

ation so that employees can avoid the errors involved in manual entry and submission of reports. The fast submission of expense re

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

port leads to quick reimbursement, which in turn provides visibility and control for the compliance of the standards of audit and

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

accounting. As it shortens the reimbursement cycle, employees’ motivation and thereby operational efficiency increases.

Every org

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

nization should have a standard format of employee expense report form that should be easy for employees to use. However, as per a

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

Following aspects would a

survey conducted by one popular Boston-based research organization, for every five dollars a company spends, one dollar is spent

dd to the challenges in developing combination products:

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

towards employee travel expenses. So the employee travel reimbursement expenditure occupies a vital role in the total expenses aft

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

er salaries. Thus, most of the companies are taking a hard look at employee travel expenses. They have begun to implement expense

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

eport management software for reducing and analyzing travel expenses so that they can make Memorandums of Understanding (MOUs) wit

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

h airline companies, hotels, etc. for availing them of discount prices.

Companies should insist on timely, accurate and honest ex

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

Professional from academic institutions, pharmaceutical industries, health care indust

pense reports. Every employee has to follow all the rules and regulations of the travel expense reimbursement policy of the organi

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

ation, while furnishing all the expense details of his travel along with documentation. After submission of the report, the employ

.

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

ee has to obtain approval from the concerned Approval Department of the company. Then only the Finance Department grants funds for

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

Companies that provide selfless information through particip

reimbursement. Also, it is the ethical responsibility of the employee to return the excess amount he has received to his employer

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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