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In order to attract the best and brightest of those newly qualified to take audit positions – both internal and external – companies are going to have to come up with more mon

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

ey. A major survey of HR professionals at the Big Four firms and recruitment firms states that salaries for entry level audit jobs will increase up to 25% ove

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

Examples of combination products may in

the next two to three years. All this has taken positions in audit out of the back office and made audit jobs some of the most hotly recruited positions out

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

here.

External auditors are charged with looking over the accounts and business dealings of firms to which they are contracted and ensuring that their practices meet all the

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

egal compliance standards. They check that the financial accounts present a ‘true and reasonable’ picture of the firm’s position, and show the profit or loss for the year. Tho

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

Combination pro

e in internal audit jobs have the task of ensuring that their firm is in compliance with increasingly complex regulations and standards and makes recommendati

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

ns to the management on how it can increase its efficiency.

In either case, to become an auditor requires passing a series of examinations and some specialised training. As t

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

e complexities of the regulations increase, most industry experts believe that there will be more and more positions that require specialised training.

Entry into Auditing

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

There are a number of ways to enter the auditing field. Generally, entry requires some experience in accountancy and training with one of the accountancy bodies. The require

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

ents for entry for under 21s are two A levels/four H grades, plus three GCSEs/S grades (A-C/1-3) including English and Maths at either level, or equivalent qualifications. A d

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

gree is not always necessary, as there are several routes of entry into accountancy for both students and adults. These include:

• Taking a position as a trainee accountant w

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

Following aspects would a

th an accountancy firm and sitting the exams while working

• Training as an accounting technician with the Association of Accounting Technicians or the Association of Charter

dd to the challenges in developing combination products:

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

d Certified Accountants (ACCA) AAT or CAT qualifications lets you out of some papers in the professional accountancy exams.

• Completing the training scheme offered by the AA

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

or ACCA to qualify for membership as an accounting technician.

Training for Auditors
Those seeking an audit job will need to register with one of the chartered accounta

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

cy bodies in the UK, and complete a series of exams. There are six chartered bodies in the UK. They are:

• The Association of Chartered Certified Accountants (ACCA)

• The

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

nstitute of Chartered Accountants in England & Wales (ICAEW)

• The Institute of Chartered Accountants of Scotland (ICAS)

• The Institute of Chartered Accountants in Irelan

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

Professional from academic institutions, pharmaceutical industries, health care indust

(ICAI)

• The Chartered Institute of Public Finance and Accountancy (CIPFA)

• The Institute of Internal Auditors (for internal audit only).

Getting on in your Career

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

The opportunities for qualified auditors are growing by leaps and bounds. There are and will be opportunities both in private firms and within the government. There are

.

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

>audit jobs available in both external roles – working independently or with a firm of auditors – and internal ones. Some of the most exciting of those roles will lea

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

Companies that provide selfless information through particip

to senior management positions. Besides standard auditing, there will be increasing opportunities for specialised positions such as insolvency, taxation and forensic auditing

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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