Tags |
|
|
Links |
|
|
Useful Advices - Key Staff can and will Leave your Business, are you Prepared?
Very few businesses can claim to be prepared for the loss of key staff. Quite often it is an unexpected and unplanned for event th
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
at causes quite a bit of disruption to business as usual.
It is quite a gut wrenching experience to see someone you have worked w
It is quite a gut wrenching experience to see someone you have worked w
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ith over a period of time leaving your business. Even if the parting of ways is on good terms with a period of handover, you just
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
know that there is so much information walking out the door with your former employee and there is nothing you can do about it.
A
A
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 this is only just the beginning…
While labouring through a period of being understaffed and overworked you are then faced with
While labouring through a period of being understaffed and overworked you are then faced with
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the task of recruiting a new employee to fill the vacant position. This is followed by the inevitable probation and training peri
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
od where, hopefully the new recruit comes up to speed and is able to pick up where the former employee left off.
The problem is:
The problem is:
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
What exactly was it that the former employee really did? They always seemed to be busy and on the rare occasion that they were abs
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ent due to illness, there were those problems that arose that were only truly resolved when they returned and took control and ‘cl
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
eaned things up’.
There has to be a better way…
Fortunately quite a bit can be done to minimize the impact of situations like th
There has to be a better way…
Fortunately quite a bit can be done to minimize the impact of situations like th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is in our businesses. And like most truly worthwhile solutions the steps required to complete this part of your businesses develop
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ment do take some effort on your part.
There is an established path that you can follow to get your business in order and the ben
There is an established path that you can follow to get your business in order and the ben
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
efits to you and your people are much farther reaching than just minimizing the impact of key staff leaving you.
The following is
The following is
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
by no means a definitive list of what is required. But it does give you some idea of the steps required.
- Create a flexible for
- Create a flexible for
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ward thinking Organization Chart defining the positions you require in your business.
- Determine what the responsibilities
- Determine what the responsibilities
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
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
are for the positions in your business.
- Document key information that is critical to your business and make it available t
- Document key information that is critical to your business and make it available t
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
o your employees.
- Work with your people to define what it is they do, how they do it and most importantly how it could be
- Work with your people to define what it is they do, how they do it and most importantly how it could be
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
done better. Record, optimize then implement the business systems you have identified.
- Assign the business systems to the
- Assign the business systems to the
.
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
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
relevant positions and monitor their use.
By consistently following these steps for all positions in your business you will insul
By consistently following these steps for all positions in your business you will insul
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ate yourself from some of the problems that occur when key employees leave your business.
Copyright 2006 Business Systems Manager
Copyright 2006 Business Systems Manager
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.usefuladvices.org.ua/article/3635/usefuladvices-Key-Staff-can-and-will-Leave-your-Business-are-you-Prepared.html">Key Staff can and will Leave your Business, are you Prepared?</a>
BB link (for phorums):
[url=http://www.usefuladvices.org.ua/article/3635/usefuladvices-Key-Staff-can-and-will-Leave-your-Business-are-you-Prepared.html]Key Staff can and will Leave your Business, are you Prepared?[/url]
Related Articles:
7 Things Some People Don’t Want You to Know About Work At Home Property Scouts
Grassroots Leadership Principles – a Review of It's Your Ship
Bookmark it:
|