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Thousands of teams are formed in businesses around the world each day. And most of those teams flounder unnecessarily for too long and some flounder forever). There is one simple practice that can improve the results of most any team, whet

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

her formed for a short project or as a new working unit. That practice is team chartering.

The team charter is a document that serves as both guidance and a roadmap for any team’s success. When used most effectively, this tool clarifies t

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

Examples of combination products may in

he purpose for the team's existence and documents the agreements amongst the team members.

Here are the seven reasons why a team chartering process will be of great benefit when forming any team.

1. Shows support and commitment. On

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

of the key components to an effective team charter is the identification of a team sponsor or a person outside of the team that can provide support and direction to the team. Many teams flounder because they don't have a “go to” person the

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

y can rely on when they get stuck or encounter obstacles. The team charter is one way for those sponsors to communicate their interest and support. The charter also provides the team with the assurance that such a person exists.

2. Set

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

Combination pro

s team direction. A good team charter will provide a team with the rationale and goals for the team. Often teams are formed without these ideas having been clearly defined. This is a problem not only for the creation of the team, but

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

akes the work of the team exceedingly difficult. How do you know what to do when you don't know the specific goals and objectives you are supposed to achieve? If I could have only one component to any team charter it would be a clear defin

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

ition of the direction, goals to be reached, and problems to be solved by the team.

3. Provides agreements and clarity. Charters provide more than just overall direction and alignment to the organization's overall purpose. The best

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

charters also provide a chance for the team itself to build agreements about how they will operate, make decisions, how often they will meet, and many other logistical issues.

4. Structures and ensures and effective planning process.
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
Too often in our fast-paced world, teams move too quickly to building a solution because they think that immediate action is required. With this perspective they spend too little time in planning for successful action. A team chartering
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
process, form, or checklist helps make sure a team plans successfully before moving forward. The time spent in planning initially will be repaid many times over during the life of the team - both in time saved and frustration avoided.

5. <
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

b>Identifies roles. Will the same person facilitate each meeting? Who is the team leader? Are there specific expectations of the team members? What roles will each individual will play? Does every team member understand why they're

dd to the challenges in developing combination products:

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

here and what expertise they can provide? A team chartering process can help answer all of these questions, and thereby help any team be more successful more quickly.

6. Outlines boundaries and scope. Often teams wonder what's insi

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

de of their control and what is actually expected of them. A good chartering process should help a team understand what their boundaries are what their limitations are what parts of the problem they are responsible for etc.

7. Sets reso

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

urces. Teams often wonder what about their level of authority. Can they hire consultants? Can they bring in outside experts? What is their budget? Can they bring in additional resources within the organization? A good chartering do

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

ument will help set both the resource requirements and levels of authority the team has to acquire more resources when needed.

8. Improves productivity, and the likelihood of successful outcome. Okay, so there are more than seven.

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

Professional from academic institutions, pharmaceutical industries, health care indust

All of the first seven benefits lead to this one - the ultimate benefit of all. Successfully chartering will improve the likelihood that the team will be less frustrated take less time and create greater results.

The importance of a team c

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

hartering process can’t be overstated. You'll notice that I have outlined the benefits and therefore implied many of the key components to a successful team charter. Remember that the form, format or template you use is less important than

.

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 time spent in conversation and dialogue to make sure what you document is realistic, and relevant. Remember too that you want to create something not as an exercise but as a living document for the team to use as both a guide and a road

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

Companies that provide selfless information through particip

map.

When you invest the time to do a team charter, you will truly help the team as a whole be more successful. And you will also be providing a highly valued structure to help individual team members be less frustrated and more productive

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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