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 
Quote:”
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 …”
And
“… 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

Wuuuuuu
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.

The Golden Award

Porridge
Well George … Does everything have a day?
Even porridge?

Seems so … October 10 th 
http://www.worldporridgeday.com/
I must remember that for next year George

I might  even have a chance to win a golden spurtle award … To tell the truth George I had not previously heard of the golden spurtle either.

Sounds even better than the golden toilet-brush award I won a few years ago.  Spoiled me.  Ever since … Well I am not nearly so excited about cleaning toilets anymore.

Spurtle-operator … Sounds almost impressive … What if I were to spread the word that I have recently become a spurtle operator? And if I were to win the spurtle award? Would I receive cards of congratulations do you suppose … Things like “so excited  for you … You must be so proud of your attainement … You see how things get better if you learn to keep your mouth shut … Didn’t I tell you things would pick up if you tried to be a bit more positive?”

Something like that … Do you suppose George? Or would it be the usual polite blank stare of utter boredom.  Would comments on this new occupation be ignored outright because nobody really honestly gives a tinker’s darn what you are doing these days.

That is … Unless it is a professional international fund-raiser where you get to wear the same t-shirt as everyone else and everybody has so much fun walking or running together to raise money to send to the charity of the day.
I say professional because such charity-events are very professional and well-planned even though they may take advantage of an army of unpaid volunteers. But guess what George? Somewhere in the charitable organizations there are often people being paid large salaries. Then there are the free trips.  These days George it is the professional charities that bring in the real money, especially if you can score a couple of lucrative board positions.

You want me to name them, give you particulars about which charities … You want documented proof? Not a report George! You don’t expect a report! Without paying me? Surely you do not expect me to work for nothing?  Hmmm no George … No board either … sorry George … Not available … I’ll be too busy operating my new spurtle promotion enterprise.

Black Friday

Is it really true George?
 … What they say about Black Friday … For instance … Everything I do from now until … Until when George? … That is the part I don’t get …
Anyway it seems that the results of my labours … My endeavours … My hard work … It is mine! All mine! I needn’t pay any taxes from now until whenever. Is that it?

Well George, I really don’t understand the whole concept.

Thick? No George. I simply don’t see how it can possibly make any difference to me. Here I am an elder artist and writer … One whose art and writings have no monetary value … Well if they did then I’d be making a living … Wouldn’t I George?  … As I was saying …

Can we get back to this George? I am busy at the moment … Trying to determine how I am going to spend my salary this month … Well I think you call it salary … Although to tell the truth George I am not sure … Is under $150 a week enough to consider a salary. Well George what I am talking about is my Elder Security check George.  

Well … Not exactly … No George I don’t know what it is called officially these days … Used to be called the Old Age Pension … Or am I getting that wrong … Well yes George I am happy to receive the check every month.  It is an affirmation that I did my time and now am able to lay back and enjoy the fruits of my labours.

Labour? Do you think George that being a housewife is not labour? 

Well yes … Labour of love … That too … 

I’m thinking about a vacuum this month George.  Well no not that one … It would take months of pension checks to pay for George. Yes George … I agree with you that I should be supporting by local business community by buying the more expensive vacuum cleaner from the local small business owner.  But look at it from the perspective of my not having any money to spend on anything else for the next several months.  

And don’t forget George! Christmas is less than a month away.  Well it is after all the short period of time that holds small local business together.  If they can make enough money  at Christmas then they are able to pay the banks the interest due on the money they have to borrow in order to stay in business for the rest of the years. 

The whole thing is a mystery to me too George.  I guess it is something best left to Economists and Accountants … Oh yes Bankers too … And yes George … Insurance Agents.

So you see George although I don’t really get this Black Friday thing and cannot really tender intelligent comments on the pros and cons of the financial world … There is one thing you must know for sure George.
I  am happy to report that I receive money  from the Canadian Government.  Yes George … Every month.

That little check might seem insignificant to you but it is mine and a lot more than I received during the years of being a stay-at-home mom when the family allowance didn’t cover the cost of … Well George let’s not talk about that right now.

Let’s just say I am appreciative. Yes … The check … That lovely little 500 $ plus a few dollars and a few cents  … Every month George … 

Yes … That lovely little greyish-brownish envelope … Is that what is meant  by a plain brown envelope George … With the  return address Matane Quebec, G4W 4N5

I love my little check from the Government of Canada. 

And the Sign Said

What George?
What word? Hearing is not quite what it once was as you know.

Quit? Is that it? What kind of an attitude is that George? You know I will not give up … Not as long as … Well never mind … 

You too George? And I considered you such a perfectly loyal magpie … Are magpies known for loyalty George? So why are you not going to share … Tell me what you saw back there?

You are very quiet George. Cat get your tongue?

So are you going to share or do I have to beat it out of you! What did the sign say?

Talk don’t fight? That’s it? Nothing more profound than that?

Oh! I see … Errrrr rather I understand … Well sort of …
You think we need better commmunication  do you George? And how do you propose we tackle that one?

OK … Well you can’t say I have not tried.

Well George … Again this morning I was booted out of a site … Accused of vile deeds … I am innocent George …

Doesn’t matter where … False accusations  … I did no wrong … Doing my Elder Duty is what I was trying to do George … Trying to post this notice that might help people in NYC

http://www.nyc.gov/html/oem/downloads/pdf/communication_board.pdf

You know George … This communication idea might be bigger than you think.

Yes of course I realize that you are a thinking entity. I’ve been told I have the same flaw. 

Yes George. Let’s talk.

Internationional Day of the Child

Today is International Childrens Day … So … Does anyone know?
November is a special day dedicated by the UN to remind us about the 
UN Declaration on the Rights of the Child and the UN Convention on the Rights of the Child. 

http://www.unicef.ca/en/take-action/article/celebrate-national-child-day-2012

Thinking about being a kid … Getting a vaccination … Ouch … 
Is it something parents still do … Get kids vaccinated? 

George … Does anyone ever ask questions about vaccinations?

You know … Questions … Like … Where do vaccinations come from?
Who authorizes … Who pays … Who gets paid … Who does research … Who conducts trials … Who participates … Who wins … Who loses … Who invests … Who oversees … Who condones … Who condemns … Who verifies … Who reports? 

Kenya? What about Kenya?

Canada Standard Sizes

Canada Standard Sizes
I am not insinuating anything George.  It really has nothing to do with me if so many people wear the same shoe size.  
The way things are going George, one of these days there won’t be a factory on this planet producing a sensible pair of good-quality shoes. So we won’t really need to worry anymore about shoe sizes.  Will we George?