Digg It - Business

DISCUSSION METHODS: There are two basic types of discussion methods; the conference method and the workshop method. The conferenc

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

e method involves meetings of staff members, usually from the same organization, and is convened to pass on information, communic

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

Examples of combination products may in

te management policies or decisions, or to solve organizational problems. These meetings are usually held for only one or two day

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

, and generally consist of large discussion groups. The workshop method, on the other hand, is usually utilized when there are pa

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

rticipants from a range of companies meeting for periods of longer than two days, for the purpose of devoting their attention to

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

Combination pro

specific problem or shared interest. The discussion groups tend to be small, and techniques such as role playing, case study, cr

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

tical incident are commonly used.

GROUP DISCUSSION GUIDELINES: 1. Planning and Preparation. Research and prepare your lesson pla

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

ns beforehand, just as you would for a lecture. Identify your objectives, and check for the availability of materials and trainin

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

rooms. 2. Opening the Session. A good beginning, with opening comments carefully made and discussion objectives clearly defined,

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

will eliminate misunderstanding and lay the groundwork for the session. 3. Presenting the Topic. Specifically define the purpose

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

f the discussion. State the problem with the use of visual aids, then identify its importance for the participants. 4. Conducting

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

Following aspects would a

the Discussion. During the course of the discussion, the trainer should try to encourage full trainee participation, and the gre

dd to the challenges in developing combination products:

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

test possible self-expression from each individual. It is helpful to ask pertinent, leading questions, as well as to give occasio

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

al summaries. You must listen carefully and attentively, for even a small lapse in attention may allow the conversation to move i

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

n the wrong direction. 5. Summarize the Discussion. At the end of the discussion, restate highlights that occurred during the co

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

rse of the session. Paraphrase any conclusions.

TRAINING THROUGH GROUP DISCUSSIONS: In the end, the only certain way to learn th

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

Professional from academic institutions, pharmaceutical industries, health care indust

art of handling discussions is to try them for yourself — see what works and what doesn’t, what seems to encourage new ideas and

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

behavioral change and what serves only to use up your valuable time and that of trainees. The best guide for the beginner is to

.

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

imply watch and listen, observe common rules of courtesy in speaking, and avoid an obviously manipulative role when you are influ

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

Companies that provide selfless information through particip

ncing the course of the discussion. Once you have mastered the technique, you may find that you never want to use a lecture again

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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/24010/diggit-Group-Discussion-Guidelines.html">Group Discussion Guidelines</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/24010/diggit-Group-Discussion-Guidelines.html]Group Discussion Guidelines[/url]

We are all creatures of habit, whether we like it or not. Even though our habits often keep us in our comfort zone instead of reaching our goals, habits per se are not necessarily bad. Without habits, we would have to make conscious decisions at every turn.

Many budding entrepreneurs are not aware of the importance of location when setting up a business. Rather in an online business many are confused or not aware that information is the key factor of success.

Some of America's greatest inventions came from African American invention - but you may not know that.

Tags

Links

Digg It - Group Discussion Guidelines

Related Articles: