Answers - Legal

For court matters involving real estate, business partnerships, Board of Directors, wrongful terminations, minority shareholder rights, and other related subject

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

s, finding the right expert court witness for the job is not always a simple process. There are many factors to consider. Here are some quick tips to narrow your

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

Examples of combination products may in

search for a dependable court witness in these fields.

The Right Qualifications

The term "expert" is crucial. Find a court witness with a s

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

lid background in the areas needed for the case. A qualified witness will usually be able to bring clear, concise information to the case. Check the witness' bac

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

ground as an expert to be sure he is qualified in the field. This will also help you discover his or her strengths and weaknesses, and to avoid major surprises a

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

Combination pro

t the last minute. For instance, both sides may have contacted the same court witness. Or, the expert may have already taken a view in a previous similar case, w

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

ich may be unhelpful in your client's case.

Also, ask to be sure the witness will accept instructions from both defendants and claimants. Many courts

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

o not favor one-sided experts, and will choose one with a reputation of being even-handed.

If the other side chooses their own expert court witness, b

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

sure your expert has similar qualifications so theirs doesn't appear to be "more qualified" than yours.

Get Clients Involved

Allow your 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

ients to meet the potential court witness before making a choice. Although the client will usually not be directly involved in the final decision, he or she may

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

till want to give input.

Choosing a Court Witness for Complex Cases

With complex cases, be sure the court witness you are considering is wi

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

Following aspects would a

ling to work closely with your team. Keep him informed of every development in the case, and involve him in important decisions that would benefit from his opini

dd to the challenges in developing combination products:

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

n. But even during a complex case, please do respect his privacy and independence.

Choosing the Same Court Witness Again

If you need to hir

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

e the same expert court witness you've used before, do another check on credentials. He could have even more beneficial credentials than before. Ask your colleag

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

es or counsel if anything has changed (for better or worse) in the expert's background.

Writing Skills

As courts move more toward the "writ

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

en report" than experts actually taking the witness stand, you'll need to be sure your expert has the correct skills to write a comprehensive report.

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

Professional from academic institutions, pharmaceutical industries, health care indust

ias and Conflict of Interest

Before hiring an expert court witness, be sure that he does not have a conflict of interest or any potential reasons to b

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

e biased in the case (past or present). Even if the expert is not biased, there may be things in his past that the other side could point out and weaken his infl

.

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

ence and evidence in the eyes of the court.

Most importantly, make sure the expert has a history of being balanced in every case. The expert court wi

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

Companies that provide selfless information through particip

ness in your case will be one of the major players, and could make the difference between winning and losing. Use the tips above to make an informed choice.

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.answers.org.ua/article/127696/answers-How-to-Choose-the-Right-Expert-Court-Witness.html">How to Choose the Right Expert Court Witness</a>

BB link (for phorums):
[url=http://www.answers.org.ua/article/127696/answers-How-to-Choose-the-Right-Expert-Court-Witness.html]How to Choose the Right Expert Court Witness[/url]

When aspiring entrepreneurs are seeking a product to create and market we strongly advise that they look around the house or garage. What is their true passion? What provides enjoyment, happiness and a feeling of contentment? When they scrap book, assemble model planes, play chess, golf, swim, or read, is there something that they often think would improve the experience. This is the surest way to discover potential opportunity in an area of great interest. You can invent that new product, and it will be rewarding to you and every user as your entrepreneurial career commences.

For many ordinary people, the Internet has opened up a whole new world of possibilities. Not only is it a place to meet new people, find some great information, entertain yourself, and do many other things, it has also become a place to do business.

Overdrafts agreements on bank accounts can be very onerous for the borrower if not used carefully. Though the bank may claim to offer free overdrafts, the “free” tag implies only that there won’t be any administrative or closing charges but there are still interests charged on the money borrowed.

Tags

Links

Answers - How to Choose the Right Expert Court Witness

Related Articles: