Advice You - Business

1. Civil engineering, construction, petrochemical, mining, and quarrying

Projects in this category are those which spring to mind most readily whenever industr

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

ial projects are mentioned. Once common feature is that the fulfillment phase must be conducted on a site that is exposed to the elements, and usually remote fr

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

Examples of combination products may in

m the contractor’s main office.

These projects incur special risks and problems of organization. They often require massive capital investment, and they deserv

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

e (but do not always get) rigorous management of progress, finance, and quality.

For very large industrial projects the funding and resources needed are often

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

oo great for one contractor to risk or even find. The organization and communications are therefore likely to be complicated by the participation of many differ

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

Combination pro

ent specialists and contractors, with the main players possibly acting together as a consortium or joint venture company.

2. Manufacturing projects

Manufactur

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

ng projects aim to produce a piece of equipment or machinery, ship, aircraft, land vehicle or some other item of specially designed hardware. The finished produ

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

ct might be purpose-built for a single customer, or the project could be generated and funded from within a company for the design and development of a new prod

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

ct intended for subsequent manufacture and sale in quantity.

Manufacturing projects are usually conducted in a factory or other home-based environment, where t

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

he company should be able to exercise on-the-spot management and provide an optimum environment.

Of course, these ideal conditions do not always apply. Some ma

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

ufacturing projects can involve work away from the home base, for example in installation, commissioning and start-up, initial customer training and subsequent

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

Following aspects would a

ervice and maintenance. More difficult is the case of a complex product (such as an aircraft) that is developed and manufactured by a consortium of companies, v

dd to the challenges in developing combination products:

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

ery possibly overlapping international borders, with all the consequent problems of risk, contractual difficulties, communication, coordination, and control.

3

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

Management projects

This class of projects proves the point that every company, whatever its size, can expect to need project management expertise at least on

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

ce in its lifetime. These are the projects that arise when companies relocate their headquarters, develop and introduce a new computer system, launch a marketin

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

campaign, prepare for a trade exhibition, produce feasibility or other study report, restructure the organization, mount a stage show, or generally engage in a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ny operation that involves the management and coordination of activities to produce an end result that is not identifiable principally as an item of hardware or

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

construction.

Although management projects might not result in a visible, tangible creation, much often depends on their successful outcome. There are well-kno

.

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

wn cases, for instance, where failure to implement a new computer system correctly has caused serious operational breakdown and has exposed the managers respons

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

Companies that provide selfless information through particip

ble to public discredit. Effective project management is at least as important for these projects as it is for the largest construction or manufacturing project

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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