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INTERNAL PUBLIC RELATIONS: Never overlook an opportunity to do internal public relations about your department and its offerings. A trai

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

ning department must, first and foremost, be visible in the organization it serves. Larry Lottier, Manager, Education of Dana Corporation

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

Examples of combination products may in

publishes a training department course catalog with faculty, course listings and course descriptions to publicize his department’s offeri

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

ngs. Gary Slobodian, Assistant Manager, Corporate Staff Development, of Great-West Life Assurance Company has found that getting training

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

on the agenda at national sales meetings increases his department’s visibility.

ACHIEVING CREDIBILITY: Make sure your department has cr

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

Combination pro

dibility within your organization. There are several ways to attain (and maintain) credibility. Your departmental plan of action must “…

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

support what the organization is trying to do, be integrated into it,” says Susan Warshauer, whose upcoming book, Inside Training and Dev

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

lopment, Creating Effective Programs, examines this. The trainings offered and the department’s overall philosophy must give tangible ans

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

wers to the needs expressed by senior management. Understanding that business plan — its goals, mission, ethics and company positioning i

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

essential to the training department being seen as “one of us” by the rest of management. To have this kind of personal credibility with

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

senior executives, a training manager must “speak the language of the suits.”

BENEFITS OF EXTERNAL RELATIONS: If you are considering us

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

Following aspects would a

ing outside consultants to supplement your in-house training staff, consider some of the benefits of external people that our experts ide

dd to the challenges in developing combination products:

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

tified: --Breadth of experience, have been inside several other organizations, more objectivity, wider range of solutions. (James Hayes)

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

--You can buy `being up to date’ with the latest technology; it costs to teach an internal person that. (Robin Grumman) --Sometimes outsi

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

e eyes see more. (Sharon Burns) --Technical experts can fill needs we can’t do in house. (Mary Belle GrosJacques) --You don’t need to pay

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

them benefits or keep them on staff. (Markus Zimmer).

DRAWBACKS OF EXTERNAL RELATIONS: If you are considering using outside consultants

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

Professional from academic institutions, pharmaceutical industries, health care indust

to supplement your in-house training staff, consider some of the drawbacks of external people that our experts identified: --They don’t

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

now the culture. (Barbara L. Thornton) --May not be available the next time you need them. (Ken Wessel)

--You never know what you’re goi

.

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

ng to get; there is an element of risk that you may not need with a first time program. (Susan Warshauer) --An internal person is hooked

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

Companies that provide selfless information through particip

nto the performance appraisal system at the company, and external person needs more supervision, more of a manager’s time. (Sharon Burns)

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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It's too easy to resign and then regret it. Use these clear tips from career and job search expert Denise Taylor to make sure you resign for the right reasons.

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More and more, management is realizing the competitive advantage that executive business coaching delivers both internally and externally. However, executive coaching is not the be all end all and requires other elements to be in place.

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