Main Subject - Business

Introduction

The purpose of this paper is to gain an understanding of project management and to give a brief overview of the methodology that underpins most formally run projects. Many organisations do not employ full time Project Managers and it is common to pull together a project team to address a specific need. While most people are not formally skilled in project methodology, taking a role in a project team can be an excellent learning opportunity and can enhance a person’s career profile.

What is a Project?

A project is a temporary and one-

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

time exercise which varies in duration. It is undertaken to address a specific need in an organisation, which may be to create a product or service or to change a business process. This is in direct contrast to how an organisation generally works on a permanent basis to produce their goods or services. For example the work of an organisation may be to manufacture trucks on a continual basis, therefore the work is considered functional as the organisation creates the same products or services over-and-over again and people hold their roles on a semi permanent basis.

What is

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

Examples of combination products may in

Project Management?

A project is generally initiated by a perceived need in an organisation. Being a one off undertaking, it will have a start and an end, constraints of budgets, time and resources and involves a purpose built team. Project teams are made up of many different team members, for example, end users/customers (of a product or service), representatives from Information Technology (IT), a project leader, business analysts, trainers, the project sponsor and other stakeholders.

Project management is the discipline of managing all the different resources and aspec

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

ts of the project in such a way that the resources will deliver all the output that is required to complete the project within the defined scope, time, and cost constraints. These are agreed upon in the project initiation stage and by the time the project begins all stakeholders and team members will have a clear understanding and acceptance of the process, methodology and expected outcomes. A good project manager utilises a formal process that can be audited and used as a blue print for the project, and this is achieved by employing a project management methodology.

Projec

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

Management Methodology

Generally, projects are split into three phases Initiation, Implementation and Closure. Each phase then has multiple checkpoints that must be met before the next phase begins. The degree to which a project is managed will depend on the size of the project. For a complex project in a large organisation that involves a number of people, resources, time and money, a more structured approach is needed, and there will be more steps built into each stage of the project to ensure that the project delivers the anticipated end result. For a simple project

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

Combination pro

in a small organisation, agreed milestones, a few checklists and someone to co-ordinate the project may be all that is required.

Initiating a Project

All projects start with an idea for a product, service, new capability or other desired outcome. The idea is communicated to the project sponsors (the people who will fund the project) using what is called either a mandate or project charter. The mandate is a document structured in a way that lays out a clear method for proposing a project and should result in a business case for the project. Once the business case h

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

as been approved a more detailed document is prepared that explains the project and it is known as the ‘The Project Definition Report’ (PD). The PD is not only used to provide detailed information on the project, but is the report on which an assessment is made as to whether the project should proceed or not. Some of the key areas it covers is the scope of the project, results of any feasibility studies, and what it is intended to deliver. As well this document will identify the key people involved, resources required, costs and expected duration as well as benefits to the business

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

A project usually has a goal (the big picture) and this has to then be broken down into objectives you can use to measure whether you have achieved your aims.

From this list you must then identify what is known as ‘Key Success Criteria’, and these are the objectives that are ‘key’ to the success or failure of the project – even if other objectives are met. These obviously vary from project to project. Once the project has been given the go ahead, then a contract document is drawn up and the project sponsor uses this to give formal agreement to funding the project and for the proje

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

t to begin. The initiation phase is then considered to be completed.

Implementing a Project

The implementation phase is about tracking and managing the project. The first thing that happens when the project begins is to use the Project Definition Report to create a project plan which defines how to perform what is detailed on the PD report. The PD is more of a summary of the project, so a detailed project plan must be created to fill in the fine detail of how the project will be run. The project plan is the central document that is used to manage the project fo

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

r its duration so getting agreement and acceptance from all of the team on aspects such as the project milestones, phases and tasks, as well as who is responsible for each task, associated timelines and what deadlines are to be met.

Some of the stages in implementing a project are quality control, progress control, change control and risk management. The first aspect we will discuss is risk management, as once you have planned the project it is important to assess any factors that could have an impact upon it. ‘Risk’ in this case is considered to be anything that c

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

uld negatively impact on the project meeting completion deadlines. For example losing team members due to illness or attrition, not having taken team members’ annual leave into consideration, the possibility of having to retrain new team members, equipment not being delivered on time or contractors going out of business. A risk log is used to record and grade risks and carries an associated action plan to minimise the identified risk. Issues management is an associated area and refers to concerns related to the project raised by any stakeholder. This phase also involves the Projec

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

Following aspects would a

Manager in quality control, whereby regular reviews are made in formalised meetings to ensure the ‘product’ that is being produced by the project is reviewed against specific pre-defined standards.

Progress Control is another responsibility of the Project Manager and is the monitoring of the project and the production of regular progress reports to communicate the progress of the project to all stakeholders of the project. As most projects do not go exactly to plan, the process of progress control is to keep an eye on the direction of the project

dd to the challenges in developing combination products:

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

and monitor the degree to which the plan is followed and take appropriate action if stages are deviating from the plan by employing regular project tracking. This is achieved by having regular checkpoints during the course of the project that will have been established in the project definition. These meetings may be weekly and are used to monitor and control all that is going on with the project as well as capture statistics from each project team member on actual start and finish dates for their allocated tasks as well as estimates for the next round of tasks.

By the nature of m

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

st projects never going exactly to plan, changes will need to be made to the length, direction and type of tasks carried out by the team. This has to be fully documented by the Project Manager in the form of ‘change control’. Change control involves the Project Manager in documenting requests for change, identifying the impact on the project if the change is to be implemented (e.g. will it affect the finish time of the project, will the project run over budget, are there enough resources) and then informing all stakeholders of the implications and alternatives that

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

he request for change has identified. The implementation phase ends once the project has achieved its goals and objectives as detailed by the key success criteria in the Project Definition Report.

Closing a Project

All projects are designed for a specific period of time and the process of project closure is an important aspect of project management. The purpose of a formal closedown to the project is to address all issues generated by the project, to release staff from the project and go through a ‘lessons learnt’ exercise. At this stage a formal acceptance from

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

the customer (the person for whom the process product has been created) is gained to indicate their sign-off on the project. This is generally done in the form of a customer acceptance form and is the formal acknowledgement from the customer that the project has ended. Once signed off, the project team is disbanded and no more work carried out. However the project team will come together for what is called a Project Review Meeting, to formally end the project and go over any outstanding issues such as ongoing maintenance, the closing of project files and conduct a team review of the

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

Professional from academic institutions, pharmaceutical industries, health care indust

project. As a result a Project Closure Report is created to formalise how successfully the project has achieved its objectives, and how well the project has performed against its original business case, the scope, project plan, budget and allocated timeframes.

The Project Manager may also create a process improvement document that reviews the processes used by the project (e.g. what did we do well, what mistakes did we make) so that the organisation can learn from this project and make further projects more successful. Because the project was run by a team of people who have spen

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

a lot of time involved in the success of a particular piece of work, that has taken them out of their usual day-to-day activities it is important to hold some type of social closing event. This might be a dinner, drinks or some type of group activity where everyone can be recognised and rewarded for their efforts.

What does it take to be a Good Project Manager?

Aside from understanding the methodology, there are other characteristics to keep in mind for successful project management. Given that any project is involved with a project team as well as the stakeholde

.

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

rs, a good Project Manager needs to have not only excellent time management skills but also good people skills such as:

Excellent communication skills.
The ability to be a team player.
Excellent interpersonal skills.
The ability to negotiate.

Experienced Project Managers believe there are two key factors in determining the success of a project: 1. Recruitment and selection of suitably qualified project members to relevant project positions is essential. Recruiting of project team members should be handled with the same discipli

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

Companies that provide selfless information through particip

e and rigour as the recruitment of new employees to fulfil the ongoing positions in the business. 2. A well documented methodology that is kept simple and easily adaptable to different sizes of projects is a critical foundation for ensuring project success. This documented methodology needs to be communicated to project team members as part of the initiation stage. This will ensure such things as everyone having a clear understanding of how to progress and what is expected at each stage and that the methodology is adapted to the specific needs of the project being undertaken

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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