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When you put the bid together, one of your most important pieces of documentation was the Project Management Plan. This document will be your

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

bible from now on, in particular the programme plan, which will take the form of a bar chart or similar and which you will probably want to pin

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

Examples of combination products may in

onto the wall of your office. This will show you the state of the project at a glance, including all the important dates and milestones, es

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

pecially payment milestones. If your plan was formulated using detailed activities for each milestone, you will need to check with the milesto

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

ne owners that these are still valid. If you didn’t use detailed activities, you might want to start now. I firmly believe that the secret of

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

Combination pro

successful Project Management is attention to detail. In a complex project, it is all too easy to lose track of some seemingly insignificant

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

little job or item which turns out to be vital to the conclusion of a milestone. Get your team to think of every tiny little thing that they w

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

ill need, especially for the early milestones and make sure that the plan is always up to date.

One of your early milestones will almost certa

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

inly be to formally issue all your other documents as well as the Project Management Plan, as these will have been at draft issue only for 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

bid. This means organising the review and signing off by senior personnel of your Quality Plan, Development Plan (if any), Sub-Contract Manage

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

ment Plan and Configuration Management Plan, to name but a few. These will then require delivery to and acceptance by, your customer.

Your Ri

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

Following aspects would a

sk Management Plan is another priority and will also need constant update and review. Make sure that your Risk Manager checks with all risk ow

dd to the challenges in developing combination products:

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

ners that they haven’t any new information which may affect the handling of an early risk. For example, say one of your risks was that one of

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

your software engineers would only be available to you part time because Project X was approaching a crucial milestone and might need extra res

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

ources. Your Technical Lead now tells you that Project X has achieved that milestone with no problems and won’t need your software engineer.

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

You can now knock that risk off your list, you don’t need to worry about it any more and you won’t need to put the fall back or mitigation plan

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

Professional from academic institutions, pharmaceutical industries, health care indust

s in place. Risk Management is a complex subject so we won’t delve into it further here, suffice to say, it is crucial to good project managem

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

ent.

Lastly, on the subject of plans, make sure that your Procurement Manager is monitoring the plans needed from your sub-contractors, if any

.

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

. These may be stand-alone plans for complex sub-contracts or may just be a contributory paragraph to some of your project plans. Either way,

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

Companies that provide selfless information through particip

they still need to be delivered in time for project management review and inclusion in the delivery of your document package to your customer.

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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