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The purpose of the Feasibility Study phase is to confirm the business requirements and benefits of the project, identify and select the preferred or most advantageous solution and to pr

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

epare an Outline Schedule for the Delivery Stage.

Key Players - The key players within the Feasibility Study Phase are:

the Feasibility Study Manager/Project Manager <

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

Examples of combination products may in

/strong>who is responsible for managing the Feasibility Study Stage;
the Business Sponsor who is responsible for signing off the key deliverables;
the <

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

trong>Sponsor's Representative who is responsible for preparing the Full Business Case and representing the Business Sponsor on day-to-day issues an matters;

the Business Sponso

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

r's cost or profit center which is responsible for providing assistance in the production of the Full Business case and obtaining the necessary authorisation for the project to progress into De

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

Combination pro

ivery;Process Description & Recommendations

The Business Sponsor should appoint a Feasibility Study Manager/Project Manager;
The Feasibility S

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

tudy Manager/Project Manager should plan the Feasibility Study Stage in detail, including the production of a document entitled the Terms of Reference for the Requirements Definition Phase;

The

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

Feasibility Study Manager/Project Manager should create the working environment including any necessary office accommodation, project filing system and specific management procedures including time reco

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

ding management;

As the Feasibility Study Phase progresses, the Business Sponsor should collect the information required to develop the benefits within the business case;

The Feasibility

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

Study Manager/Project Manager should conduct the Requirements Definition and produce the Requirements Definition Report to include:

o The business objectives and strategy;
o Functio

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

al and generic requirements;

o Data models;

o Data flow diagrams;

o Recommendations;

The Feasibility Study Manager/Project Manager should review the project with the

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

Following aspects would a

Business Sponsor to revalidate its continued viability;

The Feasibility Study Manager/Project Manager should produce the Terms of Reference for the Feasibility Study;

The Feasibility St

dd to the challenges in developing combination products:

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

udy Manager/Project Manager should undertake the Feasibility Study and produce the Feasibility Study Report which should:

o Re-iterate the objectives and business requirements;

o Specify

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

the proposed solution;

o Include a comparative analysis between the proposed solution and other options which were considered;

The Sponsor's Representative, with assistance from Finance

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

personnel and the Project Manager, should prepare the Full Business case;

The Sponsor's Representative should issue the Full Business Case for review and agreement to:

o The Business

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

Sponsor;

o The appropriate management area;

o Information Technology representatives;

o Finance Division representatives;

o Stakeholders;

o Steering Committee mem

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

Professional from academic institutions, pharmaceutical industries, health care indust

bers, if appropriate;

The Finance Division, with assistance from the Business Sponsor should produce the Project Authorisation Form and obtain the requisite corporate authorisation;

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

>The Business Sponsor should send a copy of the Full Business Case and the signed Project Authorisation Form to the appropriate management area to obtain the required resources and confirm funding for t

.

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

e project;As in the Initiation Phase, The Business Sponsor should be responsible for continually monitoring the progress of the Feasibility Study Stage. If at any time he/she has doubts about

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

Companies that provide selfless information through particip

the benefits or risks of the project, or that it will support the real business needs, it is the responsibility of the Business Sponsor to reconsider the initiative and, if necessary, terminate the work

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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