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If you receive a job offer from a Canadian company, your visa application process will be much easier!

I strongly recommend obtaining a job offer from a Canadian

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

company before submitting your visa application. If you can get this document, it will not only help you settle easier in Canada , but it will also increase your P

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

Examples of combination products may in

ss Mark assessment.

Let me explain the way a job offer will help you increase your Pass Mark assessment:

You will receive 10 points if:

- You have a permanent j

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

b offer in Canada . However, please note that this offer has to be confirmed by Human Resources and Skills Development Canada (HRSDC).

If you are already in Canad

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

(with a temporary work permit), and you decide to apply from within the country, you will also receive points in the following situations:

You will receive 10 po

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

Combination pro

ints if:

- Your temporary work permit was issued after receiving a confirmation of a job offer from Human Resources and Skills Development Canada ; - Your tempo

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

ary work permit was exempted from the requirement of a issued after receipt of a confirmation of your job offer from HRSDC (due to an international agreement).

Al

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

o if it represents a relevant benefit to Canada or its competitiveness (i.e. intra-company or post-graduate work respectively).

I recommend visiting the following

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

website for further information about the specific requirements for these situations: http://www.cic.gc.ca/english/skilled/qual-5-4.html

It is very important that

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

you understand this process, in case you are interested in using a Canadian job offer in your application.

First of all, what is The Department of Human Resource

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

and Skills Development (HRSD)?

This Department has a very specific objective: to ensure that all the Canadians have the right elements and tools to succeed in th

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

Following aspects would a

Canadian workplace.

To achieve this objective, one of the main duties of this Department is to make sure that all the foreign workers support the Canadian econom

dd to the challenges in developing combination products:

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

c growth. Foreign workers are very important for the Canadian economy!

For this reason, this Department is responsible of ensuring that the right Skilled Workers

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

are hired by the Canadian companies.

Let me explain what the Canadian companies have to do to make a permanent job offer to a Skilled Worker (I hope that is your

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

ase, you will earn 10 points!).

Basically the companies have to options:

1.They can submit an application for an HRSDC labour market opinion (normally called LMO

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

. This is one of the requirements that Citizenship and Immigration Canada (CIC) takes into consideration when they evaluate your visa application.

2.The companies

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

Professional from academic institutions, pharmaceutical industries, health care indust

can also submit an application for an HRSDC arranged employment opinion (normally called (AEO).

A positive AEO will also be extremely important when your visa is

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

processed. However, the AEO does not allow the person to work in Canada before the Permanent Residence visa is accepted and issued.

If you have already contacted

.

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

Canadian company, and they are interested in giving you a job offer, I suggest letting then know that the following two websites will be very useful.

- To apply

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

Companies that provide selfless information through particip

or the LMO : http://www.hrsdc.gc.ca/en/epb/lmd/fw/poWorkPerm.shtml

- To apply for the AEO: http://www.hrsdc.gc.ca/en/epb/lmd/fw/poArrEmp.shtml

See you in Canada

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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