Digg It - Business

At first glance, this question may seem a little silly. Of course I know what my job is. But in my experienc

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, from both sides of the fence, many of us find out the hard way just what is expected of us. So here’s a b

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

Examples of combination products may in

lueprint for any new leader that wants to make sure they focus on the right areas.

First of all, refer to y

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

our written job description. Read it several times and make sure you understand each area. Make notes for th

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

areas that you need more clarification on. Make additions where you feel it is necessary.

Next, request re

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

Combination pro

gular one on one meetings with your manager. So often I hear about managers that never have the time or feel

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

it is necessary to meet. Don’t let your manager determine if this happens. Be proactive and ask for the tim

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

.

Once you have a regular time scheduled, sit down with your manager and discuss what she expects from you.

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

Be specific. What information do you need? When do you need it? How often? Hand her a copy of your job desc

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

ription and go over each area to make sure you are both reading it the same way. Clarify what types of situa

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

ions your manager would like to be updated on, such as staffing changes personnel issues.

During each one o

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

Following aspects would a

n one, make sure that you ask for feedback on your performance. Do not wait for your formal review to find o

dd to the challenges in developing combination products:

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

ut how she feels. A formal performance review is just that…..a review, not new information that you have nev

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

er discussed.

And finally, I always suggest that leaders share their list of expectations with their team m

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

mbers. Your team produces the results, so why not ensure that they feel a sense of contribution to your succ

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

ess. Make sure that you share any and all of the credit for your performance with your team. That’s feedback

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

Professional from academic institutions, pharmaceutical industries, health care indust

that will keep their performance high.

LeadershipMento

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

.net offers free and low-cost resources for new leaders that will ensure their success in the first few

.

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

years in their position. More details be found at ww

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

Companies that provide selfless information through particip

w.leadershipmentor.net or by email at kreg@endersongroup.com

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/22583/diggit-New-Leader--Do-You-Know-What-Your-Job-Is.html">New Leader - Do You Know What Your Job Is?</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/22583/diggit-New-Leader--Do-You-Know-What-Your-Job-Is.html]New Leader - Do You Know What Your Job Is?[/url]

We may not be aware of it but the simplest of materials we use for covering our food has been around for centuries.

One morning at breakfast, my four-year-old son made me realize that we often describe our businesses in terms of how we understand them, not in terms our audiences will relate to.

This article outlines seven essential steps to setting up a successful performance improvement initiative

Tags

Links

Digg It - New Leader - Do You Know What Your Job Is?

Related Articles: