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In the past, you probably handled lots of projects on your own. But in today’s project culture organizations, you will be asked to work on a project team. And if

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 prove you work well in a team environment, you will be asked to head a project.

Here are ten project management tips: to help you put together and run a su

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

Examples of combination products may in

cessful project team for your organization.

1. Analyze the kinds of skill members you will need before you begin to assemble the team. Don’t make judgments unti

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

l you have considered all the tasks before the team.

2. Choose people for the project not because they have time available or you will comfortable working with

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

hem but because they have the right skills. Get their supervisors’ support by either personally asking for their support or having your boss or the project’s spo

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

Combination pro

sor request these individual’s cooperation.

3. Prepare a skills inventory matrix. The x-axis would identify the individuals you have chosen while the y-axis wou

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

ld list responsibilities. Make sure you’ve covered all the talent needs the project will have.

4. Keep the team’s mission upfront from the first day. Members sh

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

uld be clear about the project’s mission when they agree to work on the project. You may adapt the mission as you proceed, but you need to be sure that everyone

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

s in agreement with the mission through the life of the project, and any changes to the mission are acceptable to the project’s sponsor.

5. Build a team communi

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

cation plan. Besides meeting ground rules, which should be set at the first meeting, you want to establish communication channels among team members so there can

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

be an exchange of information in a timely and accurate way. If you plan to use reports — either in print or online — define the content, level of detail, and for

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

Following aspects would a

at for the reports. If you plan to use meetings, agree upfront how often they will be held and where, when they will be scheduled, and who will be responsible fo

dd to the challenges in developing combination products:

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

r agendas, minutes, and other logistics.

6. Besides a group communication plan, mee

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

with each team member to devise a strategy to ensure that information does not fall through a crack. It’s amazing how feathers can be ruffled when they get acci

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

entally left out of the loop on key information.

7. During meetings, ask questions to clarify or gather information on topics. Encourage probing and constructiv

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

e questions. Members shouldn’t be embarrassed to say, I didn’t understand. Would you please say that in another way so that I can understand?

8. Learn to read b

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

Professional from academic institutions, pharmaceutical industries, health care indust

tween the lines. The message isn’t only what the person may be saying. Listen for intent. Is a team member forewarning you about a problem? Perhaps he or she is

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

xpressing frustration about either a project task or the project process.

9. Build and maintain reliability by being consistent in what you ask for and what you

.

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

do. Follow through on commitments, and be clear about how decisions will be made.

10. Be flexible. As project manager, you have the formal authority that comes

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

Companies that provide selfless information through particip

with the position. That doesn’t mean you should dominate the group. Rather, rely on interpersonal skills to get others to cooperate toward achieving common goals

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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