Others - Writing and Speaking

1. Is the speaker's topic right for my audience?

2. Does the speaker have verifiable references?

3. Does the speaker have audio and/or video demonstration materials

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

? These materials should show you what the speaker is like in front of an audience. Caution: Don't get hung up on the topical information on the demo tape. Remember t

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

Examples of combination products may in

hat you are looking to see how the speaker or trainer works at the front of the room.

4. Does the speaker customize? To what level?

5. Is the speaker entertaining a

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

s well as informative?

6. Does the speaker do thorough pre- program research? Will the speaker be interviewing employees or members of the organization, or obtaining

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

information about the organization and industry to prepare for the presentation?

7. Does the speaker provide handout masters and/or finished handouts? Often your or

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

Combination pro

anization's name, logo, and particulars can be incorporated in the handout.

8. Does the speaker involve the audience? Depending on the type of presentation (is this

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 lecture or a training workshop?), the speaker should speak directly to the audience, andencourage questions.

9. Does the speaker use only clean and appropriate hum

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

or? Off-color, racial, ethnic, gender, or even slightly blue jokes or comments can turn your audience off in a heartbeat. Ask the speaker's references about this.

10

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

. Does the speaker accommodate hearing and sight impaired audience members (i.e., Handouts in Braille, audio tapes, etc.)?

11. Is the speaker accessible to all atten

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

dees before and after the event? Make sure the speaker is willing to arrive early and stay for a while after the event. The audience will want to shake hands, ask que

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

tions, get autographs, and ask about materials for sale. Tip: Always include a break after each speaker.

12. Does the speaker "hardsell" products from the platform?

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

Following aspects would a

13. Is the speaker's office responsive to requests for information? Will the speaker's bureau help you get answers to all of your questions?

14. Is the speaker easy

dd to the challenges in developing combination products:

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

to get along with (Determined from references and personal conversations)? Does he or she make stringent demands? Is he or she willing to make last-minute adjustment

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

s?

15. What is the speaker's fee?

16. Is the speaker's fee negotiable? If yes, what do you have of value to give in return for a fee reduction? Possibilities might

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

be a video tape master, list of attendees, testimonial letter, referrals, extra night accommodations, choice of time slot, choice of date, multiple performance contr

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

ct, extra publicity, spouse airfare and meals, products, or services.

17. Does the speaker offer any discounts on his or her fee (For certain geographical areas, res

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

Professional from academic institutions, pharmaceutical industries, health care indust

orts, time of year, non -profit organization)?

18. Can the speaker fill more than one slot which will save money on hiring another speaker and paying additional trav

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

el costs?

19. What are the payment terms of the speaker's contract? Typically, a 50 percent deposit is required to hold a speaker's date.

20. Can you arrange to pre

.

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

view the speaker at nearby functions to get a clear picture of the speaker's delivery, manner, language, and poise?

After all these questions have been answered to y

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

Companies that provide selfless information through particip

our satisfaction, the decision to hire or not should be much easier. Don't settle for someone who makes you uncomfortable--it's worth the time to do thorough research

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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