Drugs RSVP

I checked my RSVP list George … You know the one that tells me what Topics I need to avoid in order not to be cosidered a social deviant … 

RSVP? … You know George … Religion, Sex, Politics …
V? Not sure about that one.

Anyway what I discovered is that nowhere do I find drugs on the RSVP list.
Drugs George … we can talk about drugs.
That’s what keeps the world together. 
How do I know? 
Well I suppose I must confess to my ignorance George.  It is really not something I know for sure.

I do not really know very much of anything for sure.  What I do is just poke around and eventually find a bit of information here and a bit of information there … Oh and from what I hear on the news … And why would I not believe what I hear?

So for the drugs I went to Duke University.
Nary a sign of drugs there.

Found a drug-related something called environmental monitoring in Toronto

And auditing … Even something here called Pharmaceutical Auditing … And what you can learn if you want to take a course 
regulatory requirements and quality standards as well as the ability to carry out in-depth audits of quality systems in the pharmaceutical industry.

four main components of the quality system: management controls, design controls, production and process controls, and corrective and preventive actions …”
“… how to plan, execute, report and close-down complicated and advance pharmaceutical, biopharmaceutical and supplier audits.”

Why would someone want to close-down an audit George … Am I wrong in thinking that an audit is something that keeps the world operating the way the world is supposed to operate?

Yes I am aware that a company usually gets a warning before auditors come in … That way they can clean up their act and keep everybody happy and nobody is the wiser … Isn’t that the way it works George?

But you know what … There really is a lot more to drugs than I ever realized … Something called “Pharmaceutical Regulatory Affairs
Hmmmmm … What do you think George?

Something along the lines of 
“rules and regulations affecting pharmaceutical, biological, natural health products and medical devices.”

Some real important sounding stuff too
“international food and drug laws, regulations and guidelines … regulatory submissions and requirements … intellectual properties … pharmaceutical drug development 

Non-clinical studies … regulatory filings … human clinical trials …

Hnnnn wonder what this is: “global submission in the CTD format”

Ah hhhh here it is George
marketing applications for drugs and biologics, known as the Common Technical Document (CTD) … finalized by the International Conference on Harmonization (ICH) in 2003.  Today the CTD format is highly recommended for marketing applications in the United States, and is mandatory in other regions, including Canada, Japan, and Europe.”

Wonder what that ICH means … No George not itch … Nothing to do with being itchy … Well … Unless you have an allergy I suppose …
Then again I suppose there are companies that might be itching to get a new product out as soon as possible … You know what they say George “time is money”
No George I don’t think it has anything to do with running a business from prison. … Then again …

hmmmm good place to go to get letters after your name … Sounds real professional … Well like in all these new careers
CMW – certified medical writing
DM – document management

Check this mouthful George
GRAC – global regulatory affairs compliance

Yep … Sure are one pile of new careers George … At least they might be careers …

FDA, CBER, IND, NDA, BLA, ANDA, ABLA …. No George … No idea what they mean … Sure sounds important though … Guess you need to be an insider to understand the arcane language.

Guess that’s enough drugs for today.


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