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Could the Crusades have been launched and the soldiers armed and fed without effective project management? Could the Great Wall have been built with ingenious natural materials and a t

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

eam of millions over a span of a thousand years without project management? It is possible to say that the concept pf project management has been around since the beginning of history

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

Examples of combination products may in

. It has enabled leaders to plan bold and massive projects and manage funding, materials and labor within a designated time frame. What leaders from the distant past managed to accompl

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

ish is amazing and without the project management tools available today.

During the industrial revolution business and industry grew and expanded rapidly across continents. With the c

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

oming of automation, everything was done on a larger scale. The ability to manage projects in the way of budgets, supplies and labor at various or secondary locations was crucial and m

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

Combination pro

otivated the investigation of new ideas to streamline methods.

The Father of Scientific Management

In America in the early 1900’s a pioneering scientist named Frederick Taylor tested

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

his theories on worker productivity by creating a methodology for the measuring and performance of certain tasks by workers in steel mills. He was interested in discovering new and be

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

tter ways for workers to perform a job rather that by simply insisting that they work harder and longer. Taylor died in Philadelphia and the inscription on his tomb stone assures his p

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

lace in history: "the father of scientific management."

Taylor’s friend, Henry Gantt was the first to design charts and diagrams to document and measure the processes involved in Navy

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

ship building during WWI. By charting and analyzing each step in the ship building process he was able to see the big picture and an extract information about the relationships betwee

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

n functions. The Gantt chart became an important tool for project management and has been used for the last 100 years.

Another Milestone

In the 1950’s when the U.S. government discov

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

Following aspects would a

ered that the Russians were developing missile technology it became crucial that the “missile gap” be filled. Since the safety of the nation was at stake, the U.S. Navy wanted to build

dd to the challenges in developing combination products:

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

a system of their own immediately. To manage the building program Willard Fazar’s PERT (Program Evaluation and Review Technique) was used. PERT uses critical path methodology to contr

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

ol projects that involve massive tasks and logistics. PERT is still the standard for all Navy projects today.

Tools for Project Management

Project management in its present state is

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

a highly structured process. It involves initiating, planning, execution, monitoring, controlling and completing a plan or project as specified. It involves expertise in estimating cos

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

ts and resources, procurement of resources and supplies, organizing teams and work loads, directing and assigning roles, status reporting to upper management, risk assessment, time man

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

Professional from academic institutions, pharmaceutical industries, health care indust

agement and communication at all levels.

The expansion of businesses worldwide has helped fuel the need for better project management tools. New and more sophisticated tools to accomp

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

lish complicated project management functions have come on the market in the form of web based project management software.

Because it is web based this type of software allows teams

.

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

to communicate in real time in the office or off-site, virtually from anywhere in the world. Many programs have feature rich options and are customizable and flexible enough to meet so

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

Companies that provide selfless information through particip

phisticated project management requirements.

Project management software is probably the single most important tool a project manager will use to keep the project on track and on time

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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Digg It - Bits and Pieces: How Project Management Developed

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