Advice You - Business

Franchising companies must be very specific with regards to manager training and requiremen

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

ts for their franchised outlets. It is ultra-important to maintain consistency, quality an

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

Examples of combination products may in

customer service in a franchising company. The name brand depends on it.

It is for this

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

eason that I took the liberty of rewriting our franchise agreement and adding a clause to a

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

dress this issue. Below you will find what I came up with in regards to manager training r

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

Combination pro

quirements in our company;

4.2.3 Manager Training

Franchisor requires that Franchisee sub

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

it to Franchisor their proposed manager training program prior to their sending a new manag

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

r or crew leader to this training program. If the proposed manager training program is not

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

pproved in its original form Franchisee must modify it and resubmit a new manager training

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

roposal. This training is required of all managers, crew leaders and anyone who will be ope

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

ating the car wash trucks/units unsupervised. Franchisee will bear all costs of the propose

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

Following aspects would a

manager training, including a reasonable training fee at the then current rates.

Franchis

dd to the challenges in developing combination products:

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

r may evaluate any managers or crew leaders that Franchisee sends to their training and det

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

rmine for Franchisee if they are capable of operating a car wash truck in the Marketing Are

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

following Franchisor’s standards, specifications and procedures as outlined in the Confide

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

tial Operations Manual.

Franchisor may allow a manager or crew leader who has failed their

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

Professional from academic institutions, pharmaceutical industries, health care indust

training program a chance to retake the course one additional time.

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

S

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

nce this issue is so important to all franchising companies, it is recommended that if you

.

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

un a franchising company, you should talk to your franchising attorney and strategize how b

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

Companies that provide selfless information through particip

st to address this issue to protect your brand name. I hope you will 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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