Useful Advices - Business

Minute taking has changed over the years. The requirements and expectations of the 21st century are very different from the expectations even 10, but certainly 20 and 30 years ago. Here are s

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

ome points for you to consider about minutes and taking minutes.

• Minutes are written for people who were at the meeting, not for people who were not! They are not designed to be a story to

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

Examples of combination products may in

tell everyone who was not at the meeting, what went on. It may be smart to publish the key decisions but that is all.

• Around 60% - 70% of the minute taker's work is done before the meeting

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

begins. Most but not all of this work is in the preparation of the agenda. The agenda is essentially the draft minutes! Most experienced minute takers know this.

• If the minute taker is to

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

do the job properly, then he or she must be involved in physically preparing the agenda. The Agenda is your secret weapon!

• Shorthand is not a necessary skill for a good minute taker. Peopl

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

Combination pro

e who take minutes using shorthand sometimes take very poor minutes. The reason is that they are trained to take verbatim minutes and taking verbatim minutes rarely makes good business sense

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

n today's world of work. Remember, meetings are not a court of law.

• Modern minute takers take the minutes directly onto a laptop computer, edit as they go, and then email them to the parti

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

cipants (often from the meeting room) so that the minutes are "at the participants' desks" often before they arrive themselves. Research shows that between 50% and 60% of experienced minute t

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

kers now take the minutes directly onto a computer.

• The last type of paper to take into a meeting for the minutes is an A4 pad or a shorthand notebook. You need to taking in pre-prepared b

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

lank "forms" which you complete as the meeting progresses.

• With a very small number of exceptions, recording the names of who said what and the details of the discussion which takes place

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

is no longer required in minutes. Generally, no-one is interested in who said what, they are interested in the outcome. Often it is the ego centred people or the manipulative people who want

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

Following aspects would a

their name recorded in the minutes – no-one else cares! There are obviously some legal situations where the names are required, but foe the majority of meetings, they are not required.

• Mod

dd to the challenges in developing combination products:

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

rn minutes are action oriented, and record issues and decisions and action only, not discussion.

• Many modern minutes are taken in a table format like a spreadsheet. Contact the author for

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

examples if you are not sure how these work.

• Using a tape recorder is counter-productive and creates far more work rather than saving work as well as some Freedom Of Information complicati

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

ns. Smart minute takers never tape their meetings. It creates far more work and frequently leads to unnecessary conflict when people say "I didn't say that" and the tape clearly captures them

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

saying it.

• Modern minute takers spend very little time "transcribing" their notes – the minutes are virtually finished as the meeting finishes because they take them efficiently as the m

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

Professional from academic institutions, pharmaceutical industries, health care indust

eting progresses.

• In every type of meeting, the minute taker has a crucial role to play and therefore needs to be an active, although perhaps relatively silent, participant. There will be

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

times when you must speak. To do this you must sit next to the person in the chair. (A chairperson who understands their own role and yours, will not let you sit anywhere else!)

Taking minu

.

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

es is a job which few people enjoy but it is usually because they think that taking the minutes involves them capturing every word that is said. Once you change your mindset to one that under

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

Companies that provide selfless information through particip

stands that the purpose of minutes is to capture the issues, the decisions and the major reasons, and then the action that is required, taking minutes becomes a lot easier – almost enjoyable

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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