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Developing a strong relationship with a person in your network is helpful to you and rewarding to that person. One method that accelerates how well you know that person is to nominate him for an award. There are plenty of opportunities to do so. Here in Tol

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

edo we have many award possibilities: 20 Under 40, The Milestones, Entrepreneur of the Year and The Athena Award to name just a few. Of course, you may be aware of industry awards or even company recognitions that will deliver the same powerful thrust.

Belo

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

Examples of combination products may in

I have listed seven steps to nominating someone for an award.

1. Read the nomination form completely to understand what is needed. Note the deadline. You will want to complete the entry at least four to five days prior to this date. Follow instructions to

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

the letter. Give as much information as possible but no more than allowed. If the form asks for the nomination to be no more than two pages in length, don’t give three. Having been on several judging committees for awards, I can tell you that I probably had

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

a bias towards the ones that stayed within the guidelines. Think of reading a hundred entries. Any extra was not a good thing!

2. Select the person to nominate. Put some thought into it. Match the person to the award. Tell him that you will be nominating

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

Combination pro

him and why you think he is a good candidate. That statement alone will strengthen an already robust relationship. This step is crucial to the success. It tells him of your interest and support, but you will also need information from your nominee to delive

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

a winning entry.

3. Be sure your nominee fits all the criteria for the honor. Is there a residency requirement? Should the person have lived in a certain area for a minimum period of time? Has he demonstrated the qualities that are a fit for the award?

4

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

. Answer the nomination questionnaire in a rough draft. Give very specific examples instead of generalities. For example, “He’s a wonderful person,” really doesn’t tell the selection committee very much. Instead, “He has helped five people to start successf

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

l businesses in our community, and because of his ongoing interest, all are continuing that success today,” gives an idea of the nominee’s accomplishment. Don’t be concerned about the length of your replies, editing will come later.

5. Ask your nominee for 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

put to the questionnaire. This will be in two forms. You’ll want his perceptions, but more important, you’ll want to find out the names of other people that you can contact for information. Using others’ observations and including their names and quotes in t

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

e nomination will add credibility and power to your words.

6. Now that you have your rough draft written, it is time to edit.

a. Is it the right length? If not, more than likely it is too long. Find the core pieces that must stay, find parts that can be sh

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

Following aspects would a

ortened and eliminate lesser narrative. If you must shorten a quote, do so carefully to keep the meaning intact. Get back to the person you quoted for permission to use the new version. Fine tune until it is the required length. b. Word process your nomina

dd to the challenges in developing combination products:

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

ion. The selection committee will have many to read and react to in a fairly short time period. Make it easy for them to clearly understand why your nominee should win. c. Send your final copy to the nominee to be sure that all facts are accurate. d. Read o

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

e last time. e. If appropriate, send via email or fax. I would also follow with a paper copy either by mail or hand delivery. Emails have been known to disappear into outer space!

7. What does not work?

a) Substituting a list or organizations the nominee

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

belongs to instead of providing an explanation of how he makes a contribution to those groups. Many people can be just an inactive member of an organization. A list really doesn’t tell the story.

b) Not answering all questions on the nomination form. That

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

ould indicate the person you’ve nominated is not really a fit for the honor.

c) Some awards have multiple categories. The Milestones award in Toledo is an example of this. Choose just one category and make the best nomination for that specific section. Sel

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

Professional from academic institutions, pharmaceutical industries, health care indust

cting two or three categories, hedging your bet, means most likely that your nomination efforts will be diluted. Concentrate on just one area.

d) Using too few or no other sources for information. Even if you know him well, one person cannot know everything

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

about another.

e) Only using copies of web pages as the nomination.

f) Sending copies of articles written by or about the person nominated. Instead, if the information is that important, use a small excerpt or quote from it.

g) Not including a summary sta

.

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

ement. A short sentence or two re-stating the main criteria and how your nominee meets these will help to “close the sale.”

Finally, remember the reasons for making the effort to compile this information. Yes, winning is fun, but the actual nomination proce

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

Companies that provide selfless information through particip

s will honor the person and will help your relationship level to increase. Additionally, if he doesn’t win this year, you can nominate him again next time. He might have been a very highly-rated, runner-up and will be looked at favorably the next time around

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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You may think that it would be wonderful to be in business with your spouse, but the truth is that when life partners become business partners unspoken assumptions can cause significant problems.

When you get an interview for a compliance job it’s important to think in advance about some of the questions that you may be asked. Some foresight about the topics you may be asked about can have a real impact on how likely you are to get the job.

Looking for a career booster? Try these 5 attitudes in the workplace and see how far it can propel your career.

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