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Being able to review another persons work is one of those extremely valuable skills that someone shooting for any kind of leadership position needs to master. It can be a very challenging and intimidating task, but it doesn

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

't have to be this way. Below I've outlined some basic tips that will help you to not only be up to the task, but excel at it as well.

To note: The kind of review that I will be referencing for this article is what I call

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

Examples of combination products may in

n In-Depth Review. That means that it is for both content as well as your basic grammar and spelling.

Be familiar with the subject matter - This may seem like a no-brainer

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

if you're doing a content review, however you might be surprised how often this is not the case. If you're not familiar enough with the subject to make a good review, let them know. The last thing you want to do is make t

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

eir work worse after they incorporate your comments. One of the worst outcomes of this is that one of your comments could make their work actually incorrect, which can cascade into a bunch of different issues.

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

Combination pro

ong>Have a template for your comments - Many a time I've had someone return my work to me with their comments scattered all over the document, making me search through the document to find out what they said.

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

This is a very time consuming process, and it also leaves room to miss a comment, especially if it's a large document. Don't get me wrong, it's ok to make inline comments, however you should also mark where these comments

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

are in a predefined template. This template is usually pretty basic, a simple example would contain the name of the reviewer, date of the review, work being reviewed, and then for each comment there would be a reference num

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

ber, location, and description.

Be descriptive - If you're going to make a comment, make sure you explain exactly what you are trying to get at. It doesn't have to be a thesis, but writing

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

own "Wrong" won't cut it and only leads to you having to explain each comment. A few short sentences should usually be sufficient to explain yourself. They should contain what you are referencing, and how you think it need

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

to be changed. If you need more than that, it's probably just better to note your comment and talk to them about it.

Be constructive with your criticism - This goes hand-in-hand with the p

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

Following aspects would a

oint above. If you think something needs rework, don't put "This sucks, get rid of all of it then play in traffic". While it may be true that they need to do a lot of work, instead of pure negative criticism suggest a way

dd to the challenges in developing combination products:

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

n which it can be improved.

Be objective - This might be the most important piece of advice I can give you. Lot's of times at work we are asked to review the work of someone who we might no

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

t necessarily like or respect. This should NOT be brought into play when you actually do their review. Remember, you are reviewing their work, not them personally. Even though you may not like them, their work could be im

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

ortant to your project. Making it worse or not helping to improve that product will do you no good in the long run.

Make sure you have the latest version - This is a two way street. While

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

t is the other persons responsibility to make sure you have the latest and greatest copy of their work to review, it will be your time that is wasted if you review the wrong copy. Before you start reviewing, do a final chec

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

Professional from academic institutions, pharmaceutical industries, health care indust

k with them to make sure you have the correct copy.

Set aside conference time - Make sure that you are prepared to take some time out and answer questions about your review. I've never had

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

review where either I wasn't asked questions or asked questions myself. Know this is going to happen, and try to plan accordingly. A good idea if you are pressed for time during the day is to schedule a time to go over th

.

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

e review, and make sure that they have all their questions ready for you when you meet.

I can't stress this enough: Being able to effectively and thoroughly review someone else’

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

Companies that provide selfless information through particip

work is one of the most important skills you can develop in today's workplace. Leading others is one of the major milestones in most people's careers, and in order to do that you need to be able to review what they produce

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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Mary complained to HR and she was sent to a different office for 'better' training. She was unable to learn anything there, also. Her career in the travel industry was short, but expensive. Basically, she should never have been hired. Mary was very personable and she was probably hired on a 'gut feeling' that she would do well.

A Counsel Interview is a practical approach to dealing with staff problems - and all such situations. Issues rarely solve themselves and therefore it is essential that managers recognise that a problem exists and then solves it as rapidly as possible, because an unhappy employee will not be working at optimum performance levels.

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