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You have probably been asked to serve on a committee or team. When possible it is important to choose those teams wisely. (There are times when your manager appoints you to

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

a team and you are not given a choice.) Being a team player can give you visibility and credibility but if you choose the wrong team or work with a less than productive gro

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

Examples of combination products may in

p you will lose the benefits. How do you decide which committee to serve on and then how do you make sure that team is very successful? Here are some ideas:

1.Critical

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

ath or Personal Passion – Be sure the goal of the team is directly connected to the bottom line of the firm or is a focus of your own personal passion. You will need to

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

have energy around the mission of the team and you will want the organization to be supportive of the findings of the team.

2. Appropriate work for a Team – Decide i

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

Combination pro

f the work can only be done by a team. If the work would be better accomplished by one or two people making a decision then don’t waste your time. You’ll be spinning your wh

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

els on something that could be done faster with fewer people involved.

3. Mission of the Team – Ask about the mission of the team and what outcomes are expected. Ge

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

clarification if you don’t understand it. The team can’t do its work if the mission isn’t clear.

4. Benefit – Look to see if being on this team will benefit you in

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

some way. Perhaps it will add a skill to your resume. It might be a visible team and add to your standing in the firm or community. It could put you in contact with someo

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

ne that you want to know better.

5. Expertise Needed – Be sure your expertise is required by the team. If you feel that there is a more qualified person, give the le

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

der the name of the person who you think has that expertise. If possible decline to work on teams that don’t seem to need your specific talent. This work should be a showcas

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

Following aspects would a

for what you are uniquely qualified to do.

6. Other Members – Ask about the other members and what skills they bring to the table. Discuss adding people who have s

dd to the challenges in developing combination products:

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

ills you see are missing.

7. Quiet Members – Notice who the quiet members of the team are. Help those people to be heard by asking them to repeat their comments or

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

by asking their opinions on something. Find ways to help them participate.

8. Stay on track and focused – The team needs to keep to its timeline and within its budg

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

t. Complete your own work in the agreed upon time frame and budget and help others to do the same. Offer support to anyone who may make the team miss a deadline.

9. Te

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

m Decisions – Make sure that everyone is comfortable with the decisions that are made each step of the way. Nothing is worse than completing the task and finding that s

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

Professional from academic institutions, pharmaceutical industries, health care indust

meone disagreed with something done in the very beginning of the work.

10. Ease tension – There are often tense situations that come from teamwork. Not everyone agr

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

ees all the time. Find ways to actively listen to someone else’s point of view. Help to restate it for the group if some people don’t understand it. Make sure everyone und

.

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

rstands all sides of the issue. Take a break when things get hot. Use humor to release tension.

Many of the ideas from this list are mentioned in the book How to Be a

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

Companies that provide selfless information through particip

tar at Work Robert E. Kelley. Kelley has done research on how star performers work. This book would be useful to associates in a law firm or employees in a corporation

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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I'd rather risk my ideas and try to build a partnership with someone that can potentially lead to the creation of something so great and amazing than to play-it-safe and keep the idea to myself and not do anything with it at all — there's no fun in that.

A great idea for a church fundraiser is putting together an annual 'Church Festival' where good food, carnival games, auctions, and family fun combine for a wonderful fundraising event. The idea is to attract a broad spectrum of the local population to your fundraiser by having something for everybody.

Every business should follow a proven selling process, consistently. It could be as simple as following my award winning triple decker peanut butter and jelly sandwich recipe.

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