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Managing a project can be daunting. Whether planning your wedding, developing a new website or building your dream house by the sea, you need to employ project management techniques to help you succeed. I'll summarise the top 7 best practices at the heart of good project management which can help

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

you to achieve project success.

Define the scope and objectives

Firstly, understand the project objectives. Suppose your boss asks you to organise a blood donor campaign, is the objective to get as much blood donated as possible? Or, is it to raise the local company profile? Dec

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

Examples of combination products may in

ding the real objectives will help you plan the project.

Scope defines the boundary of the project. Is the organisation of transport to take staff to the blood bank within scope? Or, should staff make their own way there? Deciding what's in or out of scope will determine the amount of work which

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

needs performing.

Understand who the stakeholders are, what they expect to be delivered and enlist their support. Once you've defined the scope and objectives, get the stakeholders to review and agree to them.

Define the deliverables

You must define what will be delivered by th

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

project. If your project is an advertising campaign for a new chocolate bar, then one deliverable might be the artwork for an advertisement. So, decide what tangible things will be delivered and document them in enough detail to enable someone else to produce them correctly and effectively.

Key

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

Combination pro

takeholders must review the definition of deliverables and must agree they accurately reflect what must be delivered.

Project planning

Planning requires that the project manager decides which people, resources and budget are required to complete the project.

You must define wha

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

activities are required to produce the deliverables using techniques such as Work Breakdown Structures. You must estimate the time and effort required for each activity, dependencies between activities and decide a realistic schedule to complete them. Involve the project team in estimating how lo

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

g activities will take. Set milestones which indicate critical dates during the project. Write this into the project plan. Get the key stakeholders to review and agree to the plan.

Communication

Project plans are useless unless they've been communicated effectively to the projec

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

team. Every team member needs to know their responsibilities. I once worked on a project where the project manager sat in his office surrounded by huge paper schedules. The problem was, nobody on his team knew what the tasks and milestones were because he hadn't shared the plan with them. The pro

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

ect hit all kinds of problems with people doing 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 you must monitor and compare the actual progress with th

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

planned progress. You will need progress reports from project team members. You should record variations between the actual and planned cost, schedule and scope. You should report variations to your manager and key stakeholders and take corrective actions if variations get too large.

You can adj

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

Following aspects would a

ust the plan in many ways to get the project back on track but you will always end up juggling cost, scope and schedule. If the project manager changes one of these, then one or both of the other elements will inevitably need changing. It is juggling these three elements - known as the project tr

dd to the challenges in developing combination products:

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

angle - that typically causes a project manager the most headaches!

Change management

Stakeholders often change their mind about what must be delivered. Sometimes the business environment changes after the project starts, so assumptions made at the beginning of the project may n

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

longer be valid. This often means the scope or deliverables of the project need changing. If a project manager accepted all changes into the project, the project would inevitably go over budget, be late and might never be completed.

By managing changes, the project manager can make decisions abo

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

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 m

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

naging changes effectively is often a reason why projects fail.

Risk management

Risks are events which can adversely affect the successful outcome of the project. I've worked on projects where risks have included: staff lacking the technical skills to perform the work, hardware

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

Professional from academic institutions, pharmaceutical industries, health care indust

ot being delivered on time, the control room at risk of flooding and many others. Risks will vary for each project but the main risks to a project must be identified as soon as possible. Plans must be made to avoid the risk, or, if the risk cannot be avoided, to mitigate the risk to lessen its imp

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

ct if it occurs. This is known as risk management.

You don't manage all risks because there could be too many and not all risks have the same impact. So, identify all risks, estimate the likelihood of each risk occurring (1 = not likely, 2 = maybe likely, 3 = very likely). Estimate its impact on

.

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

he project (1 - low, 2 - medium, 3 - high), then multiply the two numbers together to give the risk factor. High risk factors indicate the severest risks. Manage the ten with the highest risk factors. Constantly review risks and lookout for new ones since they have a habit of occurring at any mome

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

Companies that provide selfless information through particip

t.

Not managing risks effectively is a common reason why projects fail.

Summary

Following these best practices cannot guarantee a successful project but they will provide a better chance of success. Disregarding these best practices will almost certainly lead to project failure

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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Word-of-mouth advertising is one of the cheapest and most effective types of advertising your company can invest in, but how do we generate this elusive type of advertising? Most experts in the area will say, “Get out and ‘network’.” So we go to a Chamber of Commerce meeting with dozens or even hundreds of other people trying to promote their company or service, and we attempt to promote our company or service as well. Very few people come to these meetings to buy things. The odds seem to be stacked against from the beginning, so is it any wonder why most of us come back from these meetings thinking that we just wasted an hour or two?

Although we are primarily dealing with brands and their optimization, it is important to clarify that brands do not necessarily exist in all markets. Even if brands exist in the legal sense they do not always play a role in the buying decision process of consumers. Other factors may be more important.

Think you have gone as far as you can in your present job? Instead of looking around for a similar position in another company, you may want to strike out on your own as a consultant. With a greater...

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