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E-Folder - Negotiation - Planning For A Successful Outcome
In any kind of negotiation the planning stage is probably the most important. Too often we go in badly prepared and end up giving concessions that reduce the overall profitability of the final deal. The importance of planning is in having a very clear idea before entering int
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
o the negotiation i.e.
What are my objectives?
What does the other side wish to achieve?
What information will influence the final outcome of the negotiation?
What concessions can I make?
How am I going to achieve my objectives?
What part will other people p
What are my objectives?
What does the other side wish to achieve?
What information will influence the final outcome of the negotiation?
What concessions can I make?
How am I going to achieve my objectives?
What part will other people p
; 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
lay in the negotiation?
Generally, the more time that is spent in planning and preparing for the negotiation, the more beneficial will be the final outcome.
Objectives:
Before entering into the negotiation, you need to have a clear idea of your objectives and tr
Generally, the more time that is spent in planning and preparing for the negotiation, the more beneficial will be the final outcome.
Objectives:
Before entering into the negotiation, you need to have a clear idea of your objectives and tr
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
y to work out those of the other side. Ask yourself the following questions:
What exactly do I wish to achieve from this negotiation?
Which of my objectives:
- Must I achieve?
- Do I intend to achieve?
- Would I like to achieve?
What options or alternatives would
What exactly do I wish to achieve from this negotiation?
Which of my objectives:
- Must I achieve?
- Do I intend to achieve?
- Would I like to achieve?
What options or alternatives would
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
be acceptable to me?
What are the other sides. objectives?
How does the other side see the negotiation?
Information:
It has often been said that information is power. In any negotiation, there will be four types of information that is important to the final out
What are the other sides. objectives?
How does the other side see the negotiation?
Information:
It has often been said that information is power. In any negotiation, there will be four types of information that is important to the final out
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
come.
What information do I have that the other side has also?
What information do I have that the other side does not have?
What information do I need to have before negotiating with the other side?
What information does the other side need before it can negotiat
What information do I have that the other side has also?
What information do I have that the other side does not have?
What information do I need to have before negotiating with the other side?
What information does the other side need before it can negotiat
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
e with me?
This can be particularly important when negotiating with people who concentrate on price issues.
What other things are important to this person?
What pressures does he have on him to conclude the deal?
How well is his company doing at the moment?
How
This can be particularly important when negotiating with people who concentrate on price issues.
What other things are important to this person?
What pressures does he have on him to conclude the deal?
How well is his company doing at the moment?
How
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
important is it that he deals with my company? etc.
The early phases of negotiation consist of both sides finding out more information before talking about a specific deal or set of alternatives. For example, if you find out the other side has a time deadline that only
The early phases of negotiation consist of both sides finding out more information before talking about a specific deal or set of alternatives. For example, if you find out the other side has a time deadline that only
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
your company can meet, it may give you
the chance to negotiate on more favourable price. If you know that the other side
has recently expanded their production capacity, you may be able to negotiate more
favourable terms in return for a commitment to buy certain volumes
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
over an agreed
time period.
By spending time as part of your preparation in listing what you already know and what you need to know, you will give yourself a better chance to negotiate well on your companys behalf.
Concessions :
Negotiation is a process of b
By spending time as part of your preparation in listing what you already know and what you need to know, you will give yourself a better chance to negotiate well on your companys behalf.
Concessions :
Negotiation is a process of b
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rgaining by which agreement is reached between two
or more parties. It is rare in negotiation for agreement to be reached immediately or
for each side to have identical objectives. More often than not, agreements have to
be worked out where concessions are given and rec
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
eived and this is the area where
the profitability of the final outcome will be decided.
When preparing for negotiation, it is advisable to write down a realistic assessment of how you perceive the final outcome. Find out the limits of your authority within the negotia
When preparing for negotiation, it is advisable to write down a realistic assessment of how you perceive the final outcome. Find out the limits of your authority within the negotia
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
tion and decide what you are willing and able to concede in order to
arrive at an agreement, which satisfies all parties.
Concessions have two elements; cost and value. It is possible during negotiations to concede issues that have little cost to you but have great value
Concessions have two elements; cost and value. It is possible during negotiations to concede issues that have little cost to you but have great value
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
to the other side. This
is the best type of concession to make. Avoid, however, conceding on issues that
have a high cost to you irrespective of their value to the other side.
When preparing for negotiations, ask yourself the following questions:
What is the b
When preparing for negotiations, ask yourself the following questions:
What is the b
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
est deal I could realistically achieve in this negotiation?
What is the likely outcome of the negotiation?
What is the limit of my authority?
At which point should I walk away?
What concessions are available to me?
What is the cost of each concession and what v
What is the likely outcome of the negotiation?
What is the limit of my authority?
At which point should I walk away?
What concessions are available to me?
What is the cost of each concession and what v
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
alue does each have to either side?
Strategy:
Planning your strategy is important in negotiation. Once you know your objectives, you need to work out how you are going to achieve them. It is also useful to try and see the negotiation from the other side and try a
Strategy:
Planning your strategy is important in negotiation. Once you know your objectives, you need to work out how you are going to achieve them. It is also useful to try and see the negotiation from the other side and try a
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
nd work out what their strategy will
be.
During the negotiation there will be opportunities to use various tactics and you need to decide which of these you feel comfortable with and at the same time recognise the tactics being used by the other side. Ask yourself the fo
During the negotiation there will be opportunities to use various tactics and you need to decide which of these you feel comfortable with and at the same time recognise the tactics being used by the other side. Ask yourself the fo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
llowing questions:
How am I going to achieve my objectives in this negotiation?
What is the strategy of the other side likely to be?
What tactics should I use within the negotiation?
What tactics are the other side likely to use?
And Finally - Tasks :
If
How am I going to achieve my objectives in this negotiation?
What is the strategy of the other side likely to be?
What tactics should I use within the negotiation?
What tactics are the other side likely to use?
And Finally - Tasks :
If
.
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
you go into negotiation with a colleague or colleagues, you need to decide during
the preparation phase:
What role will each team member take in the negotiation?
How can we work together in the most effective way?
Some teams of negotiators appoint team leaders, note
What role will each team member take in the negotiation?
How can we work together in the most effective way?
Some teams of negotiators appoint team leaders, note
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
takers, observers and
specialists, each with their own clearly defined authority and roles to perform.
Having a clear understanding of roles within the negotiation will make the team
approach much more effective.
Copyright © 2007 Jonathan Farrington. All rights reserve
Copyright © 2007 Jonathan Farrington. All rights reserve
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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