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Outsourcing dispute resolution services can save an organization time, stress, and money when the mediator is called in to help sort out a co-worker, senior team or other dispute before matters escalate, become entrenched, or lead to at

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

trition, grievances or litigation.

If a workplace dispute is complex or important enough that you'd like the assistance of a mediator, then you naturally want to make sure the mediator you hire is up to the job. Your selection should

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

Examples of combination products may in

e based on qualifications, experience, and good fit for your organization. You want a professional truly qualified for the job, one with whom you will feel comfortable and in whom you can have confidence.

The next time a workplace con

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

lict gets stuck and you want to bring in a third-party neutral who doesn't carry the baggage an insider does, use these questions to guide your selection of the best professional for the job:

How much mediation training and experien

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 do you have?

Mediator training programs range from the minimalist 28 hours to the more common 40 and up to, in a few instances, hundreds of hours. Look for a minimum of 40 hours of basic mediation training and 30 hours of cases,

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

Combination pro

and much more training and experience for complex conflict situations. While more training doesn't always mean a better mediator, consider this: Is only a work week's worth of preparation enough for you to choose professionals in most

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

ther fields? Be sure to ask, too, about the ways she continues to hone her skills and the number of continuing education hours she's obtained in the past year.

To what conflict resolution associations do you belong?

You're loo

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

ing for information that suggests the mediator is interested in continuing to develop his skills and knowledge. Membership in a state, regional or national conflict resolution association indicates that a mediator is professionally act

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

ve and may indicate that he's current on leading-edge research and practice through professional development and journals. Some associations have minimum membership standards, a measure of quality based on training and experience.

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

What is your approach to mediation and how will it serve my needs?

There are several different styles or approaches to mediation work (e.g., interest-based, evaluative, transformative, narrative), and most mediators align themselve

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

with an approach that meshes with their values, philosophy and beliefs about conflict and how people engage in it. Ask your prospective mediator to describe the mediation process she uses, why she uses that approach, and how it's bene

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

Following aspects would a

icial to clients. Which label your mediator puts on her approach is less important than her ability to clearly articulate why she works that way and how her style will serve you and your organization. No one style or approach is bette

dd to the challenges in developing combination products:

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

than another anymore than one kind of therapist is better than another. It's about fit with your organization's culture and the mediator's skill in applying that approach effectively.

What other credentials do you have that are be

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

neficial to this situation?

Look for a mediator whose background, prior work experience or cultural experience offers knowledge and insight that will add value to her work with you. Mediators come from all backgrounds imaginable--

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

ducators, attorneys, counselors, builders, nurses--and no one credential makes them a "better" mediator. But a mediator's background will probably inform her work and how she approaches it. And beware of assuming you need a mediator wh

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

knows your industry; while insider knowledge of an industry can help in some instances, it can also be a trap for the mediator. Mediators who know little about how things "should work" in your industry may be less likely to wear profes

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

Professional from academic institutions, pharmaceutical industries, health care indust

ional blinders that can get in their way of helping you.

What do you mean by "certified"?

Many mediators promote themselves as "certified mediators." In many instances, what they really mean is that they're "certificated"; they

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

took a training and got a certificate of attendance at the end. While there are a few certification programs, they tend to be state-based and very specific (such as certified marital mediators in New Hampshire). If the mediator says

.

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

e's certified, don't assume there's an oversight body, licensure, or any kind of admittance or minimum qualification. Always ask what it means in that instance.

Educating yourself about your prospective mediator increases the likelihoo

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

Companies that provide selfless information through particip

that your selection will be a wise one. It's generally a good idea to interview two to three mediators by telephone before making your decision. Your important or complex conflict situations deserve a skilled and talented professional

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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