Subjects - Business

When asked what part of their job they find a major time waster, many will answer loud and clear... MEETINGS. In a recent survey of business leaders, ninety percent of the responden

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

ts attributed the failure of meetings to a lack of advanced planning and organization. And, over three-fourths, indicated that they received no formal training on how to conduct a

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

Examples of combination products may in

eeting. The following four strategies can help improve the quality of your meetings.

Plan in advance.
First use these fundamental questions to lay the foundati

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

on for a productive meeting. These questions address the who, the what, and most important, the why issues. What is the goal of the meeting? Is it primarily for the dissemination

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

nd exchange of information or is it for such activities as priority setting, brainstorming, decision-making or problem-solving? What specific issues need to be addressed? Who reall

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

Combination pro

y needs to attend? And who needs just to be informed?

Set a clear and goal-oriented agenda.
A well thought-out, written agenda provides the structure for conducting

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

meeting that is worth attending - one that justifies the investment of time and energy. The well-drafted agenda should include, at a minimum, the following information: Date, time

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

(beginning and ending), place, purpose, who will be attending, and specific agenda items.

As an agenda item “budget report” is not specific enough. Is the objective to just present

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

the annual budget (an announcement) or to obtain input from the participants (a discussion) or to vote (make a decision)? In addition to a list of topics, an effective agenda shoul

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

d identify the individuals responsible for each item and a realistic time estimate.

Realistic means thinking through ahead of time who’s attending, how the conversation might flow,

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

hat problems might occur, etc. Do not try to accomplish more than is possible in the time available. Err on the side of finishing early rather than running over. Lack of a well-pr

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

Following aspects would a

epared agenda (or failure to use one well, if it exists) contributes to the common complaint that meetings are a waste of time.

Select a facilitator.
Each meeting sho

dd to the challenges in developing combination products:

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

ld have a facilitator, or meeting leader, who is responsible for keeping the meeting focused and moving forward. A good facilitator must control but not dominate; permit discussion,

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

but not let the meeting get out of hand; reach decisions, but never ride rough shod; be objective but not impersonal.

Depending on the kind of meeting and outcomes desired, the mee

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

ing facilitator can be a team member, project leader or president of the organization. At times, however, it may be necessary to bring in a professional facilitator. This person’s

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

role is to assist the group in speeding up the decision-making process, or in dealing with unavoidable conflict, or in thinking more clearly about a very complex problem.

Keep a

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

Professional from academic institutions, pharmaceutical industries, health care indust

eeting record.
Someone should be assigned to record the key information and outcomes of the meeting, that is, who is going to do what by when. This leads to greater accou

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

ntability. An evaluation of the meeting should be part of the record. It could be a simple, quick activity as asking everyone, at the end of the meeting, for a “plus” (what went w

.

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

ll) and “minus” (what could be improved). Ongoing evaluation leads to better and more productive meetings.

With advanced planning, careful preparation of an agenda and effective fac

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

Companies that provide selfless information through particip

ilitation, meetings can be a valuable activity that can lead to better business decisions, greater teamwork, and quicker problem-solving. Make sure you are making your meetings work

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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If you have been hunting for businesses for sale, you have probably noticed that there are more restaurants for sale than any other business. Why are restaurants one of the most popular businesses on sale? It may be because there is a big market for restaurants. Or it may that these restaurants are being sold by their owners because they are not bringing in enough money to stay afloat. Actually, both reasons are right.

Have you ever noticed how untrusting people are? What is the cause of all this? Is it the media scaring people into believing that everyone is a scam artist? Is it the government causing mistrust amongst the masses to further propel law enforcement agencies, which in turn make more rules and regulations to control? Is it the Internet where everyone runs around using a false “pen name” as they practice deceit?

5s is another well known business process management principles and quality control certification and has got extensive support in the manufacturing sector. 5S works mostly towards removal of wasteful processes and products within an organization, and has been derived from the Japanese words seiri, seiton, seiso, seiketsu, and shitsuke.

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