Advice You - Business

In a franchise in Company, training never stops. There is the initial training,

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

training the trainers and constant ongoing training. This must be done to ensu

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

Examples of combination products may in

re consistency, quality control and customer service.

Stands ongoing training n

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

ever stops in franchise companies, I decided to add an additional clause in our

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

franchising agreements to address this issue. Below is a copy of what I came up

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

Combination pro

with for my franchising company;

4.3 On-Going Training

Franchisee will be res

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

ponsible for all travel, food, lodging and other charges and expenses incurred b

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

y Franchisee, its trainees and its employees in connection with attendance at th

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

e training specified below, including any registration fee that may be charged b

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

y the Franchisor.

4.3.1 Specific Training

Franchisor may provide training on s

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

pecific, job-related issues for technicians, administrative staff, operations ma

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

Following aspects would a

nagers and sales and marketing personnel on an ongoing basis as Franchisor deems

dd to the challenges in developing combination products:

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

appropriate. Ongoing training classes will typically be one (1) or two (2) cale

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

ndar day sessions. Attendance requirements will be determined by the content of

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

the class.

---- ---- ---- ----

Every franchising company would be well advised

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

to address specific training, initial training and ongoing training in their ac

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

Professional from academic institutions, pharmaceutical industries, health care indust

tual franchise agreements. This way every franchise owner and outlet knows in a

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

dvance the requirements for training. Franchising companies should consult thei

.

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

r franchise attorney to make sure they are protected in the franchise agreement

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

Companies that provide selfless information through particip

to compel franchisees to participate in ongoing training. Consider this in 2006

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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Advice You - Ongoing Training Issues in Franchising Companies Addressed

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