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Actual - 10 Tips on Preparing for the First Meeting With Your Attorney
When consulting a lawyer you need to keep in mind that fact that you will be paying for every minute of his or her time. So, i
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
t is important for you to prepare well for the first meeting. If you go well prepared and carry with you a file containing all
; 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
details of the case then you will be able to keep the meeting short and to the point.
1. Be prepared to be completely profes
1. Be prepared to be completely profes
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
sional and focused. Avoid outbursts of emotion or anger.
2. Make detailed notes and a list of points that you need to bring t
2. Make detailed notes and a list of points that you need to bring t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
o the lawyer’s attention.
3. Keep ready a page containing the names, addresses, and telephone numbers of every person connect
3. Keep ready a page containing the names, addresses, and telephone numbers of every person connect
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ed with the case including witnesses if any.
4. Make 2-3 sets of all relevant documents that play a role in the case.
5. Pre
4. Make 2-3 sets of all relevant documents that play a role in the case.
5. Pre
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
pare to relate the story clearly without getting facts mixed up.
6. Be honest and open and upfront about any facts even if th
6. Be honest and open and upfront about any facts even if th
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
y are negative or bad. In case you are in the wrong your lawyer must know about it if he is to represent you efficiently.
7.
7.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Take notes when your lawyer speaks and if there is anything you don’t understand ask for a clarification. And, ensure that you
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
can do all he asks you to.
8. Discuss clearly the steps the lawyer will take. And ask how you can help by doing research or
8. Discuss clearly the steps the lawyer will take. And ask how you can help by doing research or
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ground work.
9. Make an effort to clarify things like billing, rates, what is included and what would be billed over and abov
9. Make an effort to clarify things like billing, rates, what is included and what would be billed over and abov
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
e the agreed on rate.
10. Ask for an honest opinion on how the case is likely to fare in the courts. And
Ask the lawyer’s as
10. Ask for an honest opinion on how the case is likely to fare in the courts. And
Ask the lawyer’s as
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
sistant or secretary if you should send the case file a day or two before the meeting so that the lawyer can familiarize himse
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
lf with the case details. This way in the first meeting itself the lawyer will be able to ask for clarifications or details.
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
he first meeting should inspire confidence and establish a strong foundation on which to build an understanding relationship.
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
If a case is to progress well, you and the lawyer need to understand each other well and have a through understanding of what
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
is important to the case and what is not. The lawyer must:
• Be interested in the case to give his best shot.
• Be profe
• Be interested in the case to give his best shot.
• Be profe
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ssional and organised in his working systems.
• Be honest about the case and whether he has handles such matters previous
• Be honest about the case and whether he has handles such matters previous
.
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
ly.
You must present all facts clearly, not hide any wrongs on your part, be willing to understand how the law works and be p
You must present all facts clearly, not hide any wrongs on your part, be willing to understand how the law works and be p
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
repared to devote time to help the lawyer.
If the two can work in tandem then the case will progress smoothly without hitches
If the two can work in tandem then the case will progress smoothly without hitches
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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