Advice You - Business

As both an active project manager and a project management trainer, people often ask me what are the fundamental aspects to successful project management. Whilst there have been many great books written on the subject, I always summarise what I believe to be the best practices at the heart of good project management.

Define the scope and objectives

For any project to be successful you need to understand what the project is supposed to achieve. Suppos

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

e your boss asks you to organise a campaign to get the employees to donate blood. Is the aim of this to get as much blood donated to the local blood bank? Or, is it to raise the profile of the company in the local community? Deciding what the real objective is will help you to determine how you go about planning and managing the project.

The project manager also needs to define the scope of the project. Is the organisation of transport to take staff to the blood bank w

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

Examples of combination products may in

ithin the scope of the project? Or, should staff make their own way there? Deciding which activities are within the scope or out of scope of the project has a big impact on the amount of work which needs to be performed during the project.

An understanding of who are the stakeholders is also crucial if you are going to enlist their support and understand what each person expects to be delivered from the project. Once you've defined the scope and objectives, you w

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

ll need to get the stakeholders to review them and agree to them as well as agreeing who should be on the list of stakeholders.

Define the deliverables

To achieve the desired outcome from the project, you must define what things (or products) are to be delivered by the end of the project. If your project is an advertising campaign for a new chocolate bar, then one of the deliverables might be the artwork for a newspaper advert. So, you need to decid

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

e what tangible things are to be delivered and document in enough detail what these things are. At the end of the day, someone will end up doing the work to produce the deliverable, so it needs to be clearly and unambiguously described.

Once you have defined the deliverables, you will need to have the key stakeholders review the work and get them to agree that this accurately and unambiguously reflects what they expect to be delivered from the project. Once they have a

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

Combination pro

reed, you can begin to plan the project. Not defining the deliverables in enough detail or clarity is often a reason why projects go wrong.

Project planning

This is the time when you define how you will achieve the desired outcome of the project embodied within the objectives and definition of deliverables. Planning requires that the project manager decides which people, resources and budget are required to complete the project. You will need to deci

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

de if you will break up your project into manageable phases, decide which products will be delivered in each phase, and decide the composition of your project team. Since you have already defined the deliverables, you must decide what activities are required to produce each deliverable.

You can use techniques such as Work Breakdown Structures (WBS) to help you to achieve this. You will need to estimate the time and effort required to complete each ctivity, dependenci

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

s between related activities and decide on a realistic schedule to complete the activities. It's always a good idea to involve the project team in estimating how long the activities will take since they will be the ones actually doing the work. Capture all of this into the project plan document. You also need to get the key stakeholders to review and agree to this plan.

When developing the project plan, a project manager is often under pressure to produce a plan which

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

meets the (unrealistic) expectations of some of the stakeholders. It is important here that the project manager comes up with a realistic schedule - one which he/she thinks is realistic to achieve. You will be doing nobody a favour if you succumb to pressure and agree to deliver the project in a totally unrealistic schedule.

Communication

Even the best made project plans are useless unless they have been communicated effectively to the project team. E

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

eryone on the team needs to know exactly what is expected of them, what their responsibilities are, and what they are accountable for. I once worked on a project where the project manager sat in his office surrounded by big colour print outs of his latest plans. The problem was, nobody on his team knew what the tasks and milestones were because he hadn't shared the plan with them. Needless to say the project hit all kinds of problems with people going off and doing the

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

activities which they deemed important rather than doing the activities assigned by the project manager.

Tracking and reporting project progress

Once your project is underway and you have an agreed plan, you will need to constantly monitor the actual progress of the project against the planned progress. To do this, you will need to get reports of progress from the project team members who are actually doing the work. You will need to record any variat

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

Following aspects would a

ions between the actual and planned cost, schedule and scope. You will need to report any variations to your manager and key stakeholders and take corrective actions if the variations get too large.

There are lots of ways in which you can adjust the plan in order to get the project back on track (rearrange the order of tasks, assign tasks in parallel if the variation is small, or add more staff to the project or reduce the scope if the variation is very large).

All pr

dd to the challenges in developing combination products:

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

jects require the project manager to constantly juggle three things: cost, scope and schedule. If the project manager increases one of these, then one of the other elements will inevitably need to be changed as well. So, for a project which is running behind schedule to recover so it can be delivered to it's original planned schedule, the budget might be increased by employing more staff (although this invariably never achieves the desired result of reducing the time le

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

ft to complete the project), or the scope will need to be reduced. It is the juggling of these three elements - known as the project triangle - that typically causes a project manager to tear their hair out in frustration!

Change management

All projects change in some way. Often, a key stakeholder in the middle of a project will change their mind about what the project needs to deliver. On projects of longer duration, the business environment has oft

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

n changed since the start of the project, so assumptions made at the beginning of the project may no longer be valid. This often results in the scope or deliverables of the project needing to be changed. If a project manager simply accepted all of these changes into the project, the project would inevitably be delivered late (and perhaps would never ever be completed) and would inevitably go over budget.

By managing changes, the project manager can make decisions abou

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

t whether or not to incorporate the changes immediately or in the future, or to reject them. This increases the chances of project success because the project manager controls how the changes are incorporated, can allocate resources accordingly and can plan when and how the changes are made. Not managing changes effectively is often cited as a major reason why projects fail.

Risk management

Risks are any events which can adversely affect the successfu

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

Professional from academic institutions, pharmaceutical industries, health care indust

outcome of the project. I've worked on projects where some of the risks have included: staff lacking the technical skills to perform the work properly, hardware not being delivered on time, the control room being at risk of flooding in a major thunderstorm and many others. Risks will vary from project to project but it is important to identify the main risks to a project as soon as possible and to plan the actions necessary to avoid the risk, or, if the risk cannot b

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

e avoided, to at least mitigate the risk in order to lessen its impact if it does occur. This is what is known as risk management.

Do you manage all risks? No, because there could be too many to manage, and not all risks have the same impact. So a simple way is to identify as many risks as you can, work out how likely each risk is to occur on a scale of 1 to 3 (3 being the worst), estimate its impact on the project on a scale of 1 to 3 (3 being the worst), then multipl

.

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

the two numbers together. The result is the risk weighting. A high risk weighting is the most severe risk. Just manage the top ten risks i.e. the ones with the highest risk weighting. Constantly review the risks and constantly be on the lookout for new risks since they have a habit of jumping up at unforeseen moments.

Not managing risks effectively is also often cited as a major reason why projects fail.

Summary

So, in a nutshell, these best practic

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

Companies that provide selfless information through particip

es are the main things that I would expect all project managers to do. They are applicable on all projects big or small. Project management is not rocket science. Applying best practices on your project cannot guarantee that your project comes in under budget, on time and exceeds all the expectations of the stakeholders, but applying them will certainly give you a much better chance of delivering your project successfully than if you don't apply them on your project

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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While most physicians are able to carry out routine diagnostic checks of patients and suggest suitable treatments, there are times when either the unavailability of a physician or the lack of medical infrastructural facilities requires a patient to seek instant care elsewhere. If the problem is not so serious as to call for immediate hospitalization and intensive or advanced medical supervision, an urgent care clinic can be an effective option. Similar to a hospital but not as comprehensive as to include all forms of treatment, especially during moments requiring critical care, an urgent care clinic is able to provide treatment, especially at times when a physician's clinic is closed for the day.

Customer Service is important in all businesses especially service businesses, because that is what you are selling services. If you come to a person's house or business to do a remodel or retrofit or merely some easy tenant improvements then you must give good customer service.

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