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Allow time for set-up and rehearsal and allow time between sessions to re-set meeting rooms. Book all meeting rooms in 24 ho

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

ur time blocks. Verify when presenters will arrive and if they need rehearsal time before their scheduled start time.

1. S

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

Examples of combination products may in

ating Plan. Are the tables and chairs arranged in the correct manner for the meeting format? Is the size of the room adequa

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

e for the number of people who will be in attendance? Are there removable walls and is the room sound proof from adjacent ro

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

ms and the foyer? Movable walls are not usually soundproof. A soundproof solution is to run two parallel air walls to create

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

Combination pro

a narrow corridor between them

2. Location of additional chairs. Check that extra chairs are available and easily accessib

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

e.

3. Room Temperature Locate the room climate controls (air conditioning/heating). Start with the room cooler than usual

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

, the room will warm-up with more people in the space and once the doors are closed.

4. Teleprompter, translation equipment

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

and Audio-Visual Make sure that all of the equipment needed for the meeting is on-site and ready to go.( Hand-held microphon

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

with stand, lavaliere microphones, white board with markers or projector and screen with laser pointer)

Check power capabil

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

ty and power outlets. Are electrical outlets available for plugging in laptop computers? Is there telephone connectivity an

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

Following aspects would a

is it needed? Internet connectivity? Wireless facility?

5. Podium with light and riser. Check to make sure that these

dd to the challenges in developing combination products:

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

items are available if requested by the speaker or facilitator.

6. Presentation table with water pitcher, drinking glasses,

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

encils and note pads.

7. Decorations that reinforce the meeting theme and color scheme. Check that all decorations conform

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

to fire regulations.

8. Floral arrangements and plants.

9. Signage Check the location of signage – is it clear and visib

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

e?

10. Tape recorder if an audio recording is being made and operator. Depending at the length of the presentation make su

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

Professional from academic institutions, pharmaceutical industries, health care indust

e there are adequate supplies/audio tapes to accommodate.

11. Lighting e.g., over head, obscured, variable beam, spotlight

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

, strobe lights, special effects, lights with dimmer switches

12. Position of light switches

13. Is there closed circuit

.

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

V ? Is the security adequate?

14. Radio and TV broadcasting, Videotaping?

15. Wheelchair access and space allotment on a

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

Companies that provide selfless information through particip

sle

Careful planning makes for flawless execution and a chance for attendees to get the most out of the sessions they attend

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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