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LGV stands for “Large Goods Vehicle”. This type of driving requires a licensing process. This process requires a certain amount of training.The pro

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

cess of training to be an LGV driver is slightly different than that for becoming an HGV driver. Also, those who are interested in becoming an LGV

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

Examples of combination products may in

driver need to note that The series of steps to becoming an LGV driver starts before the training. The first step to becoming this type of driver i

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 to take a medical examination which would be provided by the potential driver’s doctor. The second step to receiving LGV training would be to hav

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

e a driver’s assessment. This usually means that a driver who holds a Category C license for driving a rigid truck would have their current driving

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

Combination pro

skills assessed.

The third step of LGV training would be to enroll in a one-day theory course. After this day is completed then the LGV written t

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

est would be taken. Then, if a person has not already done so they will need to train first to gain the Category C license.If a driver already has

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

experience driving the rigid truck for which a Category C license is needed that driver will be able to prepare to obtain the Category C+E license.

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

In either case, the driver must have spent some time on the road driving a Category C vehicle before moving up to the Category C+E type vehicles.

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

After the Category C assessment, training and testing is done then the trainee will be ready for the LGV training, which requires the LGV license.

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

This training includes an assessment of skills before the LGV license is issued. The minimum age for driving an LGV vehicle is age 21 (Category C+E

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

Following aspects would a

vehicle), and the minimum age for driving an HGV (Category C vehicle) is 18. The cost of LGV training and/or HGV training varies. The cost could r

dd to the challenges in developing combination products:

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

ange from ?600 to ?1,000 for each type of training. Those who are serious about receiving this type of vehicle training are advised to get as high

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

of a quality of training as affordable.

If finances are a problem often driver trainees are able to find financial aid through a variety of sourc

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

es. For example, some people may be able to take out a loan to finance this training, or some people may receive gifts from family members in orde

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

r to receive this training. Those who complete the LGV driver training are likely to earn more than those who have completed the HGV driver traini

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng. Some drivers will make up to ?35,000 a year driving while drivers of HGV may make at least a few thousand dollars or more less than that.In ord

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

er to be a successful LGV trainee and driver those who are working to become this type of driver need to remember a few important things. For one,

.

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

those who seek this type of work must not mind driving for hours at a time. Furthermore, they must be polite to customers that they serve at pick-u

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

Companies that provide selfless information through particip

ps and drop-offs.The position of an LGV driver is a very important one so those who are involved in this type of training must not take it lightly.

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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