Advice You - Business

It is said that “it’s not what you know, but who you know that counts”. I believe that “it is what you know that will give your head start, who you know that will get you g

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

oing, who knows you (and your products or services) that will help you succeed, but what you do with your knowledge and relationships that will make you succeed.”

So, stop

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

Examples of combination products may in

thinking that you can do it all. You can’t. There are not enough hours in the day for you to do everything. Stop thinking that you are irreplaceable or that no one can do

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

nearly as good a job as you. After all, we are all mortal. As an over-achieving, overly energetic, obsessive-compulsive, competitive, I gotta-do-it-all, supermom-sister-wif

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

e-daughter-cousin-friend-colleague…I learned the hard way that it’s time to stop the madness.

Just like women do, I used to think that I have to do everything that has my

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

Combination pro

name on it because it’s a reflection of me. Even in the process of being everyone’s “go-to-woman” I knew I was abusing my body, mind, heart, soul and family, but I still di

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

d not slow down. I set such high goals for myself, that while others admired my above-average status, I still fought for the outstanding, superb, nearly perfect grade. The

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

odd thing is that I was never disappointed if I was in 2nd place or got a “B” because I always knew it was my best. Yet, I never took the opportunity to relish in my good w

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

ork, fortune, or success, because I’d be on the next 1, 2, 3 or even 4 other projects that already started.

Finally, I got a very harsh lesson in life. I got into a car ac

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

cident; I was forced to stay home away from work. I couldn’t use the computer, watch TV, listen to a radio, or even lift my babies. Basically, I was helpless. I was forced

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

to slow down and see my life flash in front of me. I immediately became humbled by the many blessings God gave me, particularly my roles as wife, mother, daughter, sister,

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

Following aspects would a

and friend. I quickly learned that life outside of God and family kept moving along without me, and nothing stopped for me, or because of me.

Praise to God, I had this lif

dd to the challenges in developing combination products:

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

e-changing lesson. As women, we need to slow down and appreciate our blessings. At EmpowerWomenNow.com I continuously praise and empower women to put themselves first and a

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

ccept the here and now.

I also learned that good things come to those who work smart, and wisely, but most of all are cordial and kind. My selfless gift of giving was payi

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

ng off. Power people (in my personal, professional, and social life) allowed me the break I needed. These power people allowed me to appreciate all the hard work and effort

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

s I put into everything I do…or did. Since I always treated my relationships with the utmost trust, honor, and respect; this was given back to me 10 times over. I gained tr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ue loyalty from clients, and my family and friends helped me and my family through my helplessness and much, much more.

These power people make up my power network, and th

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

ey allowed me to see myself in a beautiful light. By fostering good will in others, I was rewarded more than what I thought I gave. Yet, in reality, I gave so much of mysel

.

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

f through the power of networking (strictly being myself) that they gave me back exactly what I needed: patience, understanding, loyalty and love. In turn, they all told me

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

Companies that provide selfless information through particip

that “I deserve it”. The pains of my body are almost minuscule to the fortune I gained—which is my life, and the true power of a power network.

(c) 2005 Ponn M. Sabra, MP

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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Shipping containers are basically used for temporary storage of goods while it is being transported from one place to another. These containers are made out of different materials and are designed differently to fit different usages. These come in different sizes and weights as well.

Lean manufacturing is a management philosophy that aims to get the right products to the right place at the right time and in the right quantity. Lean manufacturing focuses on the reduction of the wastes that decrease efficiency and increase costs. These wastes include over-production, waiting time, processing, inventory, transportation, motion, and scrap. Lean manufacturing has been made popular by Japanese companies who have used these very effectively.

The Delaware Division of Corporations is the state government arm that takes care of matters pertaining to the incorporation of businesses in the state of Delaware. The Division of Corporations also assists in filing corporate, Delaware uniform commercial code, and tax documents. The Division has a list of prominent government officials, starting with the Secretary of State, who are available to answer questions and hear comments.

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