All posts by anayansigamboa

What Goes Around…Comes Around

In and Out of Love – Armin van Buuren feat. Sharon den Adel

Fine Without You -Armin van Buuren feat. Jennifer Rene

Tiesto – Love Comes Again

 

Ik ben met veel mensen geweest en op het einde realiseer je dat ‘te zijn’ alleen maar met één persoon kan gebeuren. Kerst, .. zomers, ontbijt
Ik doe het op mijn manier!

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

Yvonne Koelemeijer

Read All About It

Emeli Sandé – Read All About It

systemchange_noclimatechange

 

You’ve got the words to change a nation
But you’re biting your tongue
You’ve spent a life time stuck in silence
Afraid you’ll say something wrong
If no one ever hears it how we gonna learn your song?
So come on, come on
Come on, come on
You’ve got a heart as loud as lightning
So why let your voice be tamed?
Maybe we’re a little different
There’s no need to be ashamed
You’ve got the light to fight the shadows
So stop hiding it away
Come on, come on
I wanna sing, I wanna shout
I wanna scream ’til the words dry out
So put it in all of the papers,
I’m not afraid
They can read all about it
Read all about it, oh
Oh oh oh
Oh oh oh
Oh oh oh
Oh oh oh
Oh oh oh
Oh oh oh
At night we’re waking up the neighbors
While we sing away the blues
Making sure that we’re remembered, yeah
‘Cause we all matter too
If the truth has been forbidden
Then we’re breaking all the rules
So come on, come on
Come on, come on,
Let’s get the TV and the radio
To play our tune again
It’s ’bout time we got some airplay of our version of events
There’s no need to be afraid
I will sing with you my friend
Come on, come on
I wanna sing, I wanna shout
I wanna scream ’til the words dry out
So put it in all of the papers,
I’m not afraid
They can read all about it
Read all about it, oh
Oh oh oh
Oh oh oh
Oh oh oh
Oh oh oh
Oh oh oh
Oh oh oh
Yeah, we’re all wonderful, wonderful people
So when did we all get so fearful?
Now we’re finally finding our voices
So take a chance, come help me sing this
Yeah, we’re all wonderful, wonderful people
So when did we all get so fearful?
And now we’re finally finding our voices
Just take a chance, come help me sing this
I wanna sing, I wanna shout
I wanna scream ’til the words dry out
So put it in all of the papers,
I’m not afraid
They can read all about it
Read all about it, oh
Oh oh oh
Oh oh oh
Oh oh oh
Oh oh oh
Oh oh oh
Oh oh oh
I wanna sing, I wanna shout
I wanna scream ’til the words dry out
So put it in all of the papers,
I’m not afraid
They can read all about it
Read all about it, oh

 

System Change
System Change

 

 

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

Say Something

A Great Big World, Christina Aguilera

Say Something

 

 

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law). Yvonne Koelemeijer

Tribute to Evanescence (Music)

T E M P O Q U E N Ã O VO L T A A T R Á S

 

Evanescence @ Greek Theatre  15. Oktober 2017, 19:00
Evanescence @ Ryman Auditorium 25. Oktober 2017,  19:00

See you soon…

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

Remembering the Old Good Days (Music)

T E M P O Q U E N Ã O VO L T A A T R Á S

Edward Maya & Vika Jigulina – Stereo Love (Official Music Video)

When you gonna stop breaking my heart
I don’t wanna be another one
Paying for the things I never done

Don’t let go
Don’t let go
To my love

Can I get to your soul
Can you get to my thoughts
Can you promise we won’t let go
All the things that I need
All the things that you need
We can make it feel so real

Cause you can’t deny
You’ve blown my mind
When I touch your body
I feel I’m losing control

Cause you can’t deny
You’ve blown my mind
When I see you baby
I just don’t wanna let go

When you gonna stop breaking my heart
I don’t wanna be another one
Paying for the things I never done

Don’t let go
Don’t let go
To my love

I hate to see you cry
Your smile is a beautiful lie
I hate to see you cry
My love is dying inside

I hate to see you cry
Your smile is a beautiful lie
I hate to see you cry
My love is dying inside

I can fix all those lies
Oh baby, baby I run, but I’m running to you
You won’t see me cry, I’m hiding inside
My heart is in pain, but I’m smiling for you
Oh baby I’ll try to make the things right
I need more than air when I’m not with you
Please don’t ask me why, just kiss me this time
My only dream is about you and I

Can I get to your soul
Can you get to my thoughts
Can you promise we won’t let go
All the things that I need
All the things that you need
We can make it feel so real

Cause you can’t deny
You’ve blown my mind
When I touch your body
I feel I’m losing control

Cause you can’t deny
You’ve blown my mind
When I see you baby
I just don’t wanna let go

When you gonna stop breaking my heart
I don’t wanna be another one
Paying for the things I never done

Don’t let go
Don’t let go
To my love

I hate to see you cry
Your smile is a beautiful lie
I hate to see you cry
My love is dying inside

I can fix all those lies
Oh baby, baby I run, but I’m running to you
You won’t see me cry, I’m hiding inside
My heart is in pain, but I’m smiling for you
Oh baby I’ll try to make the things right
I need more than air when I’m not with you
Please don’t ask me why, just kiss me this time
My only dream is about you and I

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

ICH is coming to Town – European Medicines Agency (EMA)

The International Conference on Harmonization (ICH)  is involved in promoting public health, improve efficiency of new drug development and registration process among other objectives. In order to accomplish this, ICH has developed and implemented harmonized guidelines and standards, also known as ICH6.

ICH Steps

Over 50 guidelines on technical requirements on:
Quality, Safety and Efficacy
Efficacy – 14 topics/17 guidelines
Safety – 8 topics/16 guidelines
Quality – 9 topics/23 guidelines

  • Maintenance of ICH Controlled Terminology Lists
  • Medical dictionary for adverse event reporting and coding
    of clinical trial data (MedDRA)
  • Electronic Standards for the Transfer of Regulatory
    Information
  • Common Technical Document (CTD & eCTD)

The European Medicines Agency (EMA) is a decentralised body of the EU. EMA is responsible for centralised procedure and co-ordination of EU network + plays a role in stimulating innovation and research in the pharmaceutical sector.

EMA is not an FDA for Europe

EMA responsibility does not include:

  • Evaluation of all medicines in the EU
  • Research/development of medicines
  • Clinical trial approval
  • Medical devices
  • EU healthcare policies
EMA Regulatory Process

 

 

Conclusion: ICH-GCP guidelines brought forth public awareness that there was a need to control and regulate clinical trials dealing with drugs and human subjects.

ICH main goal is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

Source:

Guidelines on good clinical practice (European Community and within the ICH regions)  – https://ec.europa.eu/

Presentation – ICH and EU regulatory – www.ema.europa.eu

 

Recommended Posts:

https://edcdeveloper.wordpress.com/2015/05/11/are-you-practicing-gcp/

https://edcdeveloper.wordpress.com/2011/11/17/21-cfr-part-11-cheat-sheet-for-the-edc-developer/

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

Motto of the Month

Das Leben ist zu kurz um daheim zu sitzen!

 

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

Both Miserable Apart

The judgement can be of second changes. Give a second chance to a ex-partner. It is a way to see things differently. For you to be able to do things differently.

An Awakening…

Maybe you need to behave differently in the way you treat your ex-partner. Maybe some of you may want to grant a second chance to your ex-partner. But it could also highlight you want a second chance with your ex-partner.

Release the package and be able to forgive.

Try to gain more insight or a fresh perspective.  They are choosing not to take any action. Your ex-partner may have gained a new perspective and there may be things about them or their personality, their ways or attitude are needed to be changed. They are choosing not to make any actions.

They are stubborn. Yvonne Koelemeijer

Justice Tarot Card
Justice Tarot Card

These events are been brought up by their own attitude.  It could be that they have gained a fresh perspective of what they want or do not want.  But at the moment, they are choosing not to act.

In the other hand, you are needing to take a time out. Like a force isolation.  To go within yourself and reflect.

They are not taking any action.

They are feeling worried, feeling anxious; going around and around their own head.

Their heads in the cloud.

We are miserable apart, both. We waste and fade away and torture ourselves in absence; but only to breath the same air.

Your ex-partner is looking back at the past. Remembering when things were feeling content and secure. They are not choosing to take any action.

No action = no emotionally fulfill. Lack of communication.

Neither of you are happy apart. If the communication line between you both, could become better, then you will both see how miserable you are by being apart.

Should I give a second change?

Miserable Apart

Sources:

Images courtesy of Google images.

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

USA Corporations Dead Policy: Got Drug Test?

The Pointlessness of the Workplace Drug Test in the USA

There’s very little evidence it’s worth the cost or hassle and yet, USA Corporations insist on drug testing their prospective employees prior to their start date.

After living and working in Europe and Latin America, I do not understand why US Citizens do not complain? Why not ask their government to place laws into place to prohibit this practice? I feel not only it is a violation of my body but my privacy. Mind you, I do not smoke or drink anything and more or less, I have been a healthy person since I can remember. I barely use the socialist health system that it is mandated upon me. I am forced to pay for mandatory insurance so someone else can afford it even though I do not use it and when I use it, I have to pay out of my pocket anyway, so what’s the point of mandatory insurance???

So back to the mandatory drug test. Many of us have been asked to pee into a cup. As a condition of employment, and with bills to pay, we head to the lab to deliver our samples. I can understand someone operating forklifts or driving 18-wheelers should be required to some type of testing, however, someone seating at an office desk, cannot cause any injury by smoking some legalized marijuana. I do not know the details in law in each of the states where marijuana now is legal. Do corporations ask for drug testing anyway? That should seen pointless and waste of time.

US worker drug testing

As the article posted on Slate.com -Why Do Employers Still Routinely Drug-Test Workers?, explained that ‘…some testing critics, such as Adam Moore of the University of Washington, have argued that it would make more sense to do regular testing of an employee’s actual, on-the-job state of mind, rather than his or her recent drug use. If a worker nods off all the time, or sits there in an unproductive daze, what’s the difference if his problem is caused by tested substances such as marijuana or heroin, as opposed to other, legal ones? (Remember the pilot who crashed into the USS Nimitz and kicked off the modern testing frenzy? The one doped up on cold medicine?) Drugs may not even be the central problem: An airline pilot who suffers from chronic and debilitating insomnia, for example, could be more dangerous than one who does whippets on the weekend…”

But what about The Netherlands, as I can remember, Dutch people probably smoke more marijuana and joint than any US worker could dream off. Yet, they go to work, go home and smoke a joint and back to work again. Do you hear about killings at the workplace in The Netherlands? Do you hear about any other workplace related problems in The Netherlands? Remember, The Netherlands has legalized most of the marijuana consumption. Tourists come to Amsterdam just to smoke a joint. You can smell marijuana from the moment you leave the airport so what makes an European worker different than a US worker?

The same corporations operating in Europe are also operating in the USA. Do these corporations ask EU workers to pee into a cup? The answer is NO.

Drug Testing t’s an American invention

HR, recruiters and those working on workplace policies. Stop wasting people’s time. Time is money so you should be able to pay for the time I spend going into a lab for non-sense drug test. Even better, send somebody from the lab (of course,they won’t come) to my house to get a pee sample.

Time is money. Do not waste my time. Drug testing is not an indicator of my past, present or future performance as an employee.

And one more statistics by ThinkProgress:

To that end, one simply tallies up the money spent on public screenings, and compares it to the money saved by cutting off drug-abusing applicants. An analysis of seven state testing programs by ThinkProgresssuggests that governments are in the red from testing.

Source:

Why Do Employers Still Routinely Drug-Test Workers?

The Pointlessness of the Workplace Drug Test

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

Top 3 Posts at (EDC Developer)

Fist, I would like to thank everyone who has read articles posted at {EDC} Developer. Especially, my colegas and friends from India. The highest reading and hits have come from people living in India.

New to the industry? Want to get in as clinical data manager or clinical programmer? Looking for a particular topic or an answer to a question? check the contact me section.

Here are the top most searched articles this past few months:

1- Data Management: Queries in Clinical Trials

2- How to document the testing done on the edit checks?

3- Why use JReview for your Clinical Trials?

Others most read articles:

Role of Project Management and the Project Manager in Clinical Data Management

4 Programming Languages You Should Learn Right Now (eClinical Speaking)

Data Management Plan in Clinical Trials

For the search term used to find {EDC} Developer:

1-types of edit checks in clinical data management

2-Rave programming

3- pharmaceutical terminology list

4-seeking rave training (better source is mdsol.com)

5- edc programmer

6-central design tips and tricks

Thank you for reading!