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Advice Pool - Project Lifecycle Processes - Phase 3 Delivery Phase
The purpose of the Delivery phase to design, develop, test, implement and hand o
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
ver the solution identified in Phase 2, the Feasibility Study Phase.
Key Players
Key Players
; 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
> - The key players within the Delivery Phase are:
- the Business Sponsor
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
who is responsible for providing overall direction of the project and for ensur
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 that periodic reviews or health checks are performed;
the Sponsor's Represe
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ntative who is responsible for representing the Business Sponsor on day
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
-to-day matters and issues;
the Project Mana
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
ger who is responsible for managing this phase of the project, includin
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
controlling, monitoring, reviewing and reporting;
the
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
g>Stakeholders who are responsible for confirming the correct i
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nterpretation of the Users requirements;
Process Description & Recommendation
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
s
- The Project Manager must:
- Create and continuously update the Proj
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
ct Management Plan;Implement best-practice project controls; Continuously monito
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
r and control the project;Continuously review the project deliverables;
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
- The Business Sponsor should ensure that towards the end of each Stage, or at least every
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
3 months, a review or health check is performed to:
- Confirm that the project remains
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
in accordance with the corporate business objectives, and that it continues to meet a real busine
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ss need; Check performance against previously agreed success criteria; Confirm
.
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
that forecasts of benefits to be delivered remain valid; Confirm that the Phase is compl
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
ete and that the project team is adequately prepared to proceed to the next Phase;
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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