Digg It - Business

Okay, so you've figured out what kind of meeting is needed, you've planned well a

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

nd you have all the right materials. How about the meeting itself? How can you be

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

Examples of combination products may in

sure the meeting you've so carefully planned and prepared actually comes off as

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

expected?

The checklist below can help you through the process.

- Begin on time

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

, clearly stating the meeting objective and your intentions to stick to type, tim

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

Combination pro

e, topic, agenda

- Obtain agreement on the agenda items and times for each item

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

- Agenda changes must be consistent with meeting objective, type, time limits

-

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

Consider having a time keeper, rather than letting topics exceed time limits

- U

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

se action language to assign responsibilities -- What will be accomplished, who w

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

ill accomplish it, time frames and deliverables (when and how to be accomplished)

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

- Appoint a scribe to document meeting results

- Have a "parking lot" for topi

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

Following aspects would a

cs not on the agenda - at end of meeting - Review parking lot, decide resolution,

dd to the challenges in developing combination products:

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

assign follow-up, if appropriate

- Anyone who feels the process is not supporti

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

ng the objectives of the meeting should speak up and share this observation

- De

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

ide date and time for next meeting, if needed

- Debrief the meeting (should take

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

less than 5 minutes). Ask questions like Was the meeting necessary? Did the meet

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing begin and end on time? Was the agenda adhered to? Were participants objective

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

, and all viewpoints heard? Were outside interruptions avoided? Did all participa

.

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

nts have an opportunity to contribute? Were digressions and repetitions avoided?

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

Companies that provide selfless information through particip

Were win/win solutions achieved? Was feedback offered and accepted?

- End on tim

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/24784/diggit-Guidelines-For-Conducting-A-Good-Meeting.html">Guidelines For Conducting A Good Meeting</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/24784/diggit-Guidelines-For-Conducting-A-Good-Meeting.html]Guidelines For Conducting A Good Meeting[/url]

In the wake of globalization and increased business linkages, gift-giving has been moulded to suit the demands of a growth-oriented and competitive business atmosphere. MNCs, business houses with global links and export houses are the core contributors to the growth of this culture. Gifts can play a role in awarding of contracts, finalizing joint ventures and in wooing the right kind of VC. Goal-oriented gifting is a known phenomena in the Global Corporate World.

The highly successful Pineapple Dance Studios in London has been transformed from a privately owned dance studio to a to a Publicly Owned Corporation quoted on the London Stock Exchange.

Franchise company relations are critical to meet market demands and changes in customer or consumer buying behavior. Franchise relations between the franchisor and the franchised outlets or franchisees paramount to the success of the brand name.

Tags

Links

Digg It - Guidelines For Conducting A Good Meeting

Related Articles: