Main Subject - Business

I had an e-mail from Karon of Wollongong, Australia who finally plucked up the courage to ask her employer for some outside professional development training to be attended in working hours. Here is what she had to sa

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

y.

Encouraged by your newsletter I thought I would check if my company was willing to pay for training in company time so that I could advance my career within the company.

I enjoy my job and I know they value my ex

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

Examples of combination products may in

pertise, but they had never thought of staff development and although surprised by my request, and my sales pitch as to how it can benefit them, they said yes. That was the beginning of a nightmare. I knew I wanted

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

to do Project Management, but had no idea how to look for an accredited course, if possible.

I tried the Universities and TAFE colleges. None offered courses specifically dealing with Project Management, so I turned

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

to the Internet. It soon became apparent that you needed to belong to an Industry Association or Professional Organization to find relevant training in business hours.

One Industry Training company was prepared to t

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

Combination pro

ake me if they could not fill places with members. It was also costly - $6,000 just for a two day course! There was a possibility of a Project Management course starting the following month, but I wouldn’t expect my

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

company to pay for what I thought was an outrageous cost.

I turned to a friend, Margo, because I couldn’t take up any more time looking around. She got back to me and said. “ I have Googled and Yahooed, and I could

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

only come up with Distance Learning.” This sounded ok because I could take time off work to complete my assignments, which was an alternative option. She said she wanted to know what I thought about it before she wen

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

t any further. “Sounds ok, but how do you know if the company is credible” I asked? ” I don’t know, I will have to find out,” she stated officiously.

I didn’t hear from her for about 2 weeks and I was really busy du

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

ring this period. Ironically I was in the middle of managing a project that was outside my division and area of expertise, and I felt very much out of my depth, but still coping.

The Project Manager, who had impleme

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

nted and started the project, was very qualified and experienced. I was told, with a grin, that he had caught the mumps. My boss thought I could step in and handle it because of my interest in Project Management, and

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

Following aspects would a

it was a good career opportunity for me.

I was beginning to think the whole idea was a disaster. I couldn’t even find a course on Project Management and here I was being thrown into the deep end.

Then Margot got b

dd to the challenges in developing combination products:

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

ack to me and said that only one Distance Learning Programmes had the course I wanted but they were only offered once a year and it the next one was booked out. Now that distance learning held no further options, my

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

friend tenaciously pursued the task she was given and eventually found a course. She rang back and said she had found one appropriate course and asked me if I wanted a holiday. She just said wait for the brochure, i

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

t is in the mail.

The brochure showed the 5 day course was being held on the Gold Coast in Queensland, Australia. I thought the price was reasonable, compared to what I had seen locally, and it was off season so 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

accommodation and meals package was quite reasonable, but still $5,000 I sighed, and put it back in my in box.

My manager, who rarely ventures into my work area, passed by and saw it. “Oh you have found a course ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve you?” he asked. “Yeah right, I could do with the holiday” I said. I nearly fell on the floor when he said, “let me take it away and I will make some enquiries.”

He came back in the afternoon and had spoken to pe

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

ople within the industry and he was told the training was excellent and coincidently was highly credible within our own industry. “You can’t miss this,” he said. “book yourself in.” My mind was racing – kids - husba

.

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

nd - meals, and who would drive the kids to school etc. I rang my husband and he said “great, don’t worry darling, we will work it out."

The biggest hurdle in this professional development idea is finding an appropri

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

Companies that provide selfless information through particip

ate course at the right price. Margot said she came up with some interesting courses from Distance Learning packages. They are worth having a look at.

The moral of this story is, if you want to something, always ask

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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Gaining new business is not easy when you go it alone, but when you team up with others as alliances or power teams, you have a bigger advantage.

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