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Has it ever happened that you ask someone, what seems to be a simple question, and they don’t seem to be able to give you a straight answer?

Do you won

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

der if you are not communicating clearly?

There are a number of factors that can have an impact on the person you asked the question of. Once you have

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

Examples of combination products may in

determined that the question was not unreasonable, was understandable and you are clear on what your goal is in seeking the answer, it’s time to conside

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

other conditions the recipient of the question may be facing to determine how you can get the answer you need.

For example, I asked a producer for a d

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

ate that the commercials we were working on would be ready. His response was 3 emails. The first said that he just received the information last night a

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

Combination pro

5pm. The second, the order was not in yet. The third, they’ll be ready middle of next week. None of those answers was what I required to be confident

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

in telling the client when he could hear his commercials.

1. When you require a specific answer, provide specific parameters in the question, and be op

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

n to negotiate terms.

2. Ask if there is anything you can do to make it easier for them to give you an answer.

3. Give as much information as possible

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

without adding unnecessary information. Maybe the most they can decide on at that time is "when" they can give you an answer, so give them that opportu

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

ity. i.e. I need an answer by Date.

4. If your question has more than one part break it up into individual questions.

5. Listen more closely to what t

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

he person you are speaking to is saying. Ask a question rather than jumping in with a comment or getting right back to your own agenda.

6. Ask for feed

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

Following aspects would a

back in the conversation.

7. If it’s an email communication ….sometimes email just won’t do it…pick up the phone and talk.

8. Don’t rush them…plan suf

dd to the challenges in developing combination products:

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

icient time so they don’t feel pressured.

9. Ask yourself if you are putting up any barriers? Does the person feel there is a right and wrong answer an

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

d they are going to be judged for giving the wrong one? Do they feel you are trying to control them or set their schedule? Although your intent may not

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

e any of these, is it possible that they might construe it that way?

10. Ask for their help. Someone who feels as if they are more alright, more knowle

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

dgeable, more in control about whatever it is than you are, is more likely to rise to occasion to prove that you were right to ask them for help.

11. I

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

Professional from academic institutions, pharmaceutical industries, health care indust

they respond in an emotional manner, acknowledge that you understand that they could feel that way. It doesn’t mean that you agree or that you would ac

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

t the same way in that situation. It does mean that you heard what they said and aren’t judging them for it.

12. Show genuine appreciation for what the

.

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

know, who they are and/or what they can do, make them feel included in the process.

13. Finally, if none of those things work, just state the facts an

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

Companies that provide selfless information through particip

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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One of the big mistakes systems make is to assume that anyone can be a mentor. WRONG! This mentality often is the same mentality that causes systems to move good technical staff into management positions and then wonder why the new manager is failing. Technical knowledge does not presume possessing the knowledge and skills to be an effective mentor.

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A student's portfolio is a collection of accomplishments, reflecting his or her performance and interest levels. Portfolios serve as evaluators of personal strengths and weaknesses of the students and illustrate work progress. Student portfolios can include a record of comments to support cooperative teaming. A video recording of students speaking French in the classroom can be shared and used to evaluate conversational skills.

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