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Advice You - Ten Things You Should Focus on to Transform Your Finance Function
1. Optimizing processes Documenting and standardizing processes to minimize exceptions
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
and improve efficiency. Staff should always be knowledgeable on these processes.
2. Control e
2. Control e
; 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
vironment A key finance function objective is protecting assets. Ensuring critical controls, p
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
licies and procedures are in place is crucial, while at the same time not creating bottlenecks in the o
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ganization.
3. Optimizing available technology Ensuring processes are appropriately e
3. Optimizing available technology Ensuring processes are appropriately e
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
abled by technology and new functionality is constantly incorporated into existing processes in a contr
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
lled manner. Staff must be knowledgeable on the technology.
4. Performance management
4. Performance management
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
>Another key objective of the finance function is creating value. This is possible through appropriate
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
eporting, information visibility and performance measurement systems for the organization.
5.
5.
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
ompliance Robust compliance as efficiently and cost effectively as possible. Identify all comp
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
iance and timing, assign responsibilities and providers and monitor.
6. Retaining staff
6. Retaining staff
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
g>Recruiting and training staff is expensive. Retaining staff is not as expensive. Identify your perfor
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
ers and make plans around each one.
7. Planning for the future Considering appropriat
7. Planning for the future Considering appropriat
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
strategies such as outsourcing or shared services to support process and technology requirements, as w
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
ell as more effectively serve the organization.
8. Managing working capital Monitorin
8. Managing working capital Monitorin
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
and managing working capital, especially payables, receivables and cash. Ensuring appropriate strategi
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
s are in place to minimize working capital with process, technology and controls.
9. Tax manag
9. Tax manag
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ment Monitoring all aspects of tax compliance and planning, using external providers efficient
.
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
y and effectively.
10. Reporting standards Following statutory reporting standards an
10. Reporting standards Following statutory reporting standards an
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
ensuring the organizations reputation is at all times protected with respect to reporting requirements
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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