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Cases - Expense Report Approval
An expense report is the statement listing all the travel expenses of an employee owing to a business visit or plea
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
sure visit. The employee has to fill up the standard expense report of his employer either online or manually and s
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ubmit it to the authorized Approval Department within a specified time period for claiming reimbursement. The emplo
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
yee has to furnish the signature of the authorized person who has approved his visit. He/she needs to submit all th
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e vouchers and bills of his expenses during his travel like air/train fare, hotel accommodations, transportation ex
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
penses, food expenditures and others. It is the responsibility of the employee to obtain the prior approval for his
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
visit from the appropriate authority. The appropriate authority differs from organization to organization, and it
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
will be decided by organization’s structure. The approval authority may sometimes be the immediate boss or departme
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ntal budget officer.
Once the employee gets the approval from the concerned authority, the company may give some a
Once the employee gets the approval from the concerned authority, the company may give some a
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
dvance amount for meeting substantially higher expenses like travel-fare, or provide an advance for hotel accommoda
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ions, etc. However, the employee should not use the advance amount given for travel fare for lodging, conference fe
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
e or for other expenses. He/she should the specified advance for the respective purpose only. The request for an ad
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
vance beyond a certain limit specified by the organization should be approved by the head of the branch, like a Vic
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
e-President. During his travel, the employee should not forget to collect bills for his expenses, however small the
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
y may be. He/she has to submit all the bills along with his expense report form to his employer.
After filling up
After filling up
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
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
the expense report, the employee has to forward the form to his immediate approval authority. The approval authorit
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
y will review the details of all the expenses furnished by the employee for reimbursement. He or she will verify th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e signatures of the traveler and the travel approval authority. Once every item mentioned in the report is set fort
.
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
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
h as per the organization’s guidelines, the approval authority signs the report along with all the necessary docume
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ntation and forwards it to the finance department, giving the green signal for the grant of funds for reimbursement
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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