Main Subject - Business

You just recently found out that you have been selected by your company to be the Project Officer for an upcoming major project. This project will generate much success fo

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

r your business if it is executed properly. That is great but where do you even get started? Certainly, one of the most difficult parts about project management is just g

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

Examples of combination products may in

etting the darn thing underway. Procrastination, difficulty in finding the right organizational structure and obtaining relief from your other job functions can be major o

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

bstacles to successful project management. It is very common for one to falter at this initiation stage. With desperate frustration, some organizers will scratch developi

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

ng a plan of their own and instead move onto a plan that will likely be doomed from the outset. This article will help you avoid this by giving you some tips that should b

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

Combination pro

e considered when beginning this new project management venture.

Your first step for successful project management will be to define your project objectives and constraint

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

s. This essentially creates a blueprint on how you intend to approach this project and helps to figure what resources will be needed. Your project objectives and constrai

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

nts must be crystal clear so everyone involved in the project fully understands what is trying to be accomplished. This should also help them understand how the success or

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

failure of the project will be measured. The objectives that you define will include numerous different areas of the project. For example, these may include time objecti

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

ves, technical objectives and budgetary objectives. Project constraints may include time, technology, personnel, budgetary and cultural. You will then want to develop you

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

project's strategy that will determine how these objectives will be attained.

The next step in project management is to identify all of the project stakeholders. These a

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

Following aspects would a

re the people that will make or break the project or have the most to gain or lose from it. One of top stakeholders in this project is the company or firm that you are wor

dd to the challenges in developing combination products:

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

king for. Are these project objectives and strategies consistent with the mission and goals of the firm? This project needs to fit appropriately with the other aspects of

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

the firm as well. Without this cohesiveness, the project is not likely to get off the ground due to a lack of support from the project manager's superiors and other stake

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

holders.

Successful project management will also require you to perform a SWOT analysis. A SWOT analysis will determine the project strengths, weaknesses, opportunities a

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

nd threats. All projects involve some element of risk so it is essential to evaluate any threats that may potentially appear later on as obstacles. Doing this will help t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he project team prepare to handle these obstacles and minimize their influence. While evaluating your opportunities will likely reveal your initial project objectives, you

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

also may find that secondary beneficial opportunities exist that the group was unable to pinpoint the first time around.

Getting started with any project is unquestionabl

.

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 one of the most difficult parts of project management. Once the project gets underway, the momentum will help carry you through. Defining your project objectives, the s

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

Companies that provide selfless information through particip

trategy to achieve these objectives, identifying your stakeholders and performing a SWOT analysis will help you build this needed momentum for successful project management

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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