Digg It - Business

One of the most powerful leadership tools available is the ability to facilitate a meeting or a work session. Too often, these gatherin

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

gs are a disorganized jumble of unprocessed ideas that leave participants frustrated and feeling that “nothing much got accomplished”.

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

Examples of combination products may in

Effective facilitation is simple. With a bit of practice, anyone can learn how to do it. There are 10 key steps to becoming a master f

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

cilitator:

1.Prepare in advance. Put yourself in the role of a participant and think through the logical elements that 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

come together in order to achieve the desired outcome.

2.Define the meeting objective. Finish the sentence: ‘the purpose of thi

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

Combination pro

s meeting is….”. Make sure that you and everyone else is clear what the expected meeting outcomes are.

3.Set your time parameters.<

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

b> A startling amount can be accomplished in an hour if you know that’s the time frame. Pay attention to the clock.

4.Define a set

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

of questions that lead logically to the desired outcome. As you’re preparing the questions, work your way through the possible answ

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

ers. This will help you define the next question.

5.Record feedback. Use a flipchart, digital projector or some other public re

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

ording device so participants can see, discuss and revisit their answers. While modern technology is great, flipcharts have a significa

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

nt advantage in keeping the process leader front and center, and in control of the meeting.

6.Keep the process moving. Don’t dw

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

Following aspects would a

ell on any topic for too long. Frequently, the best thinking comes fast and early – belaboring an issue is seldom worth the loss of mom

dd to the challenges in developing combination products:

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

ntum.

7.Get contribution from everyone. Don’t let participants hang back in the weeds and don’t let any one person dominate.

8

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

.Listen hard. Don’t be afraid to recast a participant’s perspective in simple terms that everyone understands. This will make yo

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

u a hero. Be respectful of the participant and their input and insure you’ve recast their thoughts accurately.

9.Learn some simple

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

voting techniques. Sometimes it’s necessary to prioritize ideas or action plans. Getting participants to do their own prioritizatio

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

Professional from academic institutions, pharmaceutical industries, health care indust

n, then capturing their ranking and adding up their votes is a simple, effective way to get group consensus.

10.End by summarizing

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

agreements, next steps and who’s responsible. That way, things will get done and no one will leave the meeting feeling that your me

.

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

ting or work session was a waste of time.

Effective facilitation significantly increases the value of group meetings. It saves time a

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

Companies that provide selfless information through particip

nd increases the quality of output. With some logical thinking, preparation and practice, anyone can become a great meeting facilitator

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

Digg It - Make Every Meeting Productive: Become a Great Facilitator

Related Articles: