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Main Subject - Beware the bcc: or Watch Your Back with E-mail
E-mail is a wonderful and inexpensive way of sending a postcard that anyone in the entire world can potentially read! Just about anyone with technical savvy could intercept it a
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
long its route over multiple servers. They could be nosey, officially spying, downright malicious, or just doing their jobs as managers.
- Rest assured there is only a small gu
- Rest assured there is only a small gu
; 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
rantee of privacy to e-mail, whether at home or at work. Unless you have permission from someone to encrypt an e-mail, and the tools to do it, a hacker can read anything you wri
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
te. E-mail can be intercepted by government officials, and most certainly, it can be monitored and read by your company’s IT department.
- Most of us who are computer-literate
- Most of us who are computer-literate
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ould not live without our e-mail now. Everything of importance in our lives is linked through it, from family and friends to our professional networks. Most of us also know that
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e-mail at the office has additional rules and restrictions that the prudent employee will adhere to without whining: no jokes, no love notes, no spam, no personal anything may
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
eem harsh, but their absence cuts the incidence of virus attacks to the minimum.
- Employers make back-up copies of everything every night, either locally, or on remote data st
- Employers make back-up copies of everything every night, either locally, or on remote data st
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
orage servers, or both. The process is an absolute must; it is critical to a business’s survival in the event of a disaster. Everything is backed up, including databases, docum
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nts, customer records, e-mails, and instant messaging systems. So be careful what you write, and where you send it. The results can be worse than being caught sailing paper airp
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
lanes across the room in school.
- One feature of e-mail that many users are not familiar with is the bcc – blind carbon copy (left over from typewriter days). bcc is no
- One feature of e-mail that many users are not familiar with is the bcc – blind carbon copy (left over from typewriter days). bcc is no
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
as innocuous as it seems. The sender selects bcc when he or she wants to surreptitiously send a copy of an e-mail message to someone, without any of the other recipients knowin
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
g about it.
- If you select Reply All, bcc recipients will usually show up, depending on the e-mail system you are using, and any Reply All monitoring plug-in you might have in
- If you select Reply All, bcc recipients will usually show up, depending on the e-mail system you are using, and any Reply All monitoring plug-in you might have in
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
talled. That is, unless the sender was savvy enough to lock down the e-mail. If it is thoroughly locked down, you won’t be able to reply to the sender. In fact, you won’t even b
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
e able to print out the e-mail for your own records.
- Locking down e-mail is an act of absolute control/confidentiality from someone who is typically quite angry, yet fears co
- Locking down e-mail is an act of absolute control/confidentiality from someone who is typically quite angry, yet fears co
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
sequences. It means that no one can respond, short of creating a separate e-mail, and even then, you won’t easily be able to defend yourself to everyone (cc and bcc) that the se
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
nder notified.
- Not that all is lost. There are ways of capturing the contents, which I will not list here. Heaven forbid that certain people should find out you’re not as dum
- Not that all is lost. There are ways of capturing the contents, which I will not list here. Heaven forbid that certain people should find out you’re not as dum
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
as they think you are. (You can always check out a few technical sites.) If you can’t get the e-mail through simple means, an attorney can go after it for you later on, if you
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
can provide the date, and who sent it at which company.
- In any event, make notes and keep them at home. Even truculent managers aren’t allowed to destroy employee records, so
- In any event, make notes and keep them at home. Even truculent managers aren’t allowed to destroy employee records, so
.
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
the e-mail itself will be there in the future, if you need it down the road. Of course, your attorney will have to get past the whole issue of confidential company records not b
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
eing released to anyone, but if your case is serious enough, pursue it. In the meantime, even quiet people can betray you, so watch your back with bcc.
© 2006 Shirley Ann Parke
© 2006 Shirley Ann Parke
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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