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Many Independent Financial Advisers (IFA’s) are considering CeMAP training as a way to increase their business profitability by adding to the

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

range of products that they are able to advise on. By undertaking the CeMAP training and becoming qualified, an Independent Financial Adviser can then offer mo

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

Examples of combination products may in

tgage advice as well as advising on the range of products in his or her current portfolio.

The CeMAP qualification recognises the training th

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

t the IFA has already undertaken by exempting a fully qualified IFA from the CeMAP 1 exam. In other words, if the IFA has already passed either CeFA 1 OR FPC 1

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

then they are exempt from having to sit the CeMAP 1 exam. This is obviously a major benefit for an IFA who is already qualified because he or she will not the

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

Combination pro

have to study the CeMAP training material for the Module 1 exam. This exemption is because the FPC 1 and CeFA 1 exams cover the same material as the CeMAP 1 e

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

am and so a duplicate test is not required.

In this situation the IFA would then study the CeMAP training material for the CeMAP 2 and 3 exam

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

s. As the CeMAP 2 and 3 exams are actually based on the same syllabus, this makes the conversion from IFA to mortgage adviser relatively straight forward. The

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

eMAP 2 / 3 syllabus looks at mortgage products, payment methods and the complete house purchase process and hence provides all of the information to ensure tha

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

the IFA is then fully equipped with the knowledge needed to give professional mortgage advice.

In the CeMAP exam process, the CeMAP 2 paper asks fact based q

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

estions on the syllabus, whereas the CeMAP 3 exam takes this knowledge and turns it into case studies that test not only the candidate’s knowledge but also the

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

Following aspects would a

interpretation of that knowledge into real world situations. This case study, or synoptic, exam format is a major strength of the CeMAP exam process ensuring

dd to the challenges in developing combination products:

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

hat the newly qualified mortgage advisers are able to apply their knowledge to the real world and not just recite facts.

Until 2005 there was something called

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

the CeMAP Bridge paper which provided a conversion for IFA’s into the mortgage industry, however this was scrapped in 2005 and consequently IF

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

A’s now have to undertake CeMAP training for Modules 2 and 3. This is a more comprehensive exam process and ensures a greater degree of uniformity across the m

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

rtgage industry.

One major benefit for IFA’s in undertaking CeMAP training and becoming mortgage advisers in addition to their current role,

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

Professional from academic institutions, pharmaceutical industries, health care indust

s that they gain extra product range which they can offer to their existing customers. This means that their existing client base is also a possible source of

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

additional business through the mortgage market. Having completed the CeMAP training, the IFA is then able to expand his or her business model to encompass the

.

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

increased product range. This can yield many benefits, not just for the business, but also for the clients who can now avail themselves of a more complete advi

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

Companies that provide selfless information through particip

ory service. For more information on flexible Home Study for CeMAP training then click on the link

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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