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E-Folder - To Whom Do You Think You're Writing?
When writing business documents—letters, memos, reports, even emails—one thing to keep in mind is that it is NEVER about you, the writer. It is ALWAYS about
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
your reader: who are they, what do they already know about the subject matter, and what do they need or want to know? Always write from the reader’s point
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
f view.
Who is your reader?
Who is your reader?
- Are they male or female?
- What is their age?
While too much focus on gender and age can
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
lead to stereotyping, it is important to understand that basic differences exist in the way men and women and people of different generations communicate. F
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
r example, men are usually more direct, while most women like to first build rapport. Regarding age, today’s workplace may have at least three generations o
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
employees: Radio-Agers (born between 1922 and 1945); Baby Boomers (1947-1964); Generation X (1965-1980). Generation Y (1981- 2000) haven’t been in the work
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
orce very long, so they may or may not need be considered. Generally speaking, Radio-Agers have a strong work ethic, lead by directives and communicate form
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
lly, via memos. Baby Boomers like to work hard and play hard, prefer a consensual leadership style and in-person communication. Generation X are self-relian
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
, challenge others (i.e., ask why), and want immediate communication.
- Where are they in the company hierarchy (job ti
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
le, department)?
What is their educational background?
What do they know?
What do they know?
- Do they know less, as much, or more than you abo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t this subject?
What do they think they know?
Are they familiar with industry jargon and acronyms?
What do they need
What do they need
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
want to know?
- How interested are they in reading this information?
- What is important to them?
- Do they need to respond to or a
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
t upon the information? If so, do you need to give them direction?
Always write from the reader’s point of view.
Always write from the reader’s point of view.
- Use language that i
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
meaningful to your reader.
Avoid jargon (industry-specific terminology) unless you’re sure they understand it.
Anticipate questions or
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
bjections and address them in the document. Don’t wait for the reader to come to you after they’ve read it.
You’re probably wondering what you
You’re probably wondering what you
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
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
hould do if you’re writing to several people—different generations, male and female, at different levels of the company hierarchy, with various educational
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ackgrounds and subject knowledge. In these situations, it’s best to target the middle of the road: relay enough information in easily understood language so
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
that the least knowledgeable reader is brought up-to-speed, without talking down to them or insulting the intelligence of the more knowledgeable reader. If
.
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
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
ou use jargon, acronyms or abbreviations, define them the first time you use them. Ask yourself how you would relay this information if you were talking to
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ach person individually. Then put yourself in the reader’s place: ask yourself, “If I were this person, how would I want this information communicated to me
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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