Category Archives: Project Management

Opportunity to Forgive

Forgiveness is simply a process where we seek to eliminate from our mind and heart all the resentment and hurt that we are holding in our being because of what someone said or did towards us.

I was told that healing is closure. It is time for that closure otherwise I will carry out that karma until I do so. Today, I am releasing my forgiveness so we can finally move on and break this karmic pattern.

Today I choose to send love energy to those who hurt me and who are hurting…

Forgiveness is something we have to find within ourselves.

#lettinggo #forgiveness #powerofmanifestation

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Hallo From The Other Side Adele

Fuzzy = Hallo

╔┓┏╦━━╦┓╔┓╔━━╗

║┗┛║┗━╣┃║┃║ X X ║

Hello, it’s me I was wondering if after all these years you’d like to meet To go over everything They say that time’s supposed to heal ya But I ain’t done much healing

Hello, can you hear me? I’m in California dreaming about who we used to be When we were younger and free I’ve forgotten how it felt Before the world fell at our feet There’s such a difference between us And a million miles Hello from the other side I must have called a thousand times To tell you I’m sorry for everything that I’ve done But when I call you never seem to be home Hello from the outside At least I can say that I’ve tried To tell you I’m sorry for breaking your heart But it don’t matter, it clearly doesn’t tear you apart Anymore

Hello, how are you? It’s so typical of me to talk about myself, I’m sorry I hope that you’re well Did you ever make it out of that town Where nothing ever happened? It’s no secret that the both of us Are running out of time So hello from the other side (other side) I must have called a thousand times (thousand times) To tell you I’m sorry for everything that I’ve done But when I call you never seem to be home Hello from the outside (outside) At least I can say that I’ve tried (I’ve tried) To tell you I’m sorry for breaking your heart But it don’t matter, it clearly doesn’t tear you apart Anymore (Highs, highs, highs, highs, lows, lows, lows, lows) Anymore (Highs, highs, highs, highs, lows, lows, lows, lows) Anymore (Highs, highs, highs, highs, lows, lows, lows, lows) Anymore (Highs, highs, highs, highs, lows, lows, lows, lows) Anymore Hello from the other side (other side) I must have called a thousand times (thousand times) To tell you I’m sorry for everything that I’ve done But when I call you never seem to be home Hello from the outside (outside) At least I can say that I’ve tried (I’ve tried) To tell you I’m sorry for breaking your heart But it don’t matter, it clearly doesn’t tear you apart Anymore

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Op deze belangrijke datum…Sacrifice Anouk

 

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Change – Amsterdam

At the end of 2008 and close to the holidays, a friend of mine from the States told me to visit this psychic lady from downtown (she was the one interested in having a palm reading). I don’t believe it much so I went along. After her reading, the lady asked me if I wanted a palm reading. I said, “why not.” Nothing to lose as I am already here.

Amsterdam

All I can remember her saying ”…soon you will meet someone and move…I see a lot of water surrounding this place…lots of water…” I said to myself. “That must be Panama.” We have the canal, rivers, lakes and two oceans…When her last words were “I see a trip to Europe”.

That was a day like today in 2009.

My life changed a day like today when I received an email that changed my life forever. A move to Europe [Amsterdam] that I never saw coming. Life has a lot of ups and downs. Like a roller coaster, I was up and many times down but it made me stronger than ever and open my life to the reality of love.

 

In front of the place I met my destiny – All is Change – Soulmate!

Life has a lot of twist and turns…

So what’s a soul mate? I was told that my past relationship was of a soul mate type.  Someone I spent at least one past life together. It sure felt more like a karmic relationship. I needed to pay a karmic debt.

One thing is clear to me. My soulmate must be in the same ‘vibrational path’ before we meet again. Whether in this life or the next (I hope not to be back to this planet… :-)…if there is no vibration, it will never happen.

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EMA and The Netherlands Biopharm Opportunities

The European Medicines Agency (EMA) is relocating from London to Amsterdam.

According to EMA, the Seat Agreement allows EMA to function independently in the Netherlands. Similar agreements apply to other EU agencies located in the Netherlands.

On Friday, 13 April 2018, the Dutch Council of Ministers agreed to sign the document.

Amsterdam – EMA

Quantify research reported earlier this year that the shift of the EMA to Holland will be a welcome boon to that country, particularly due to some companies shuttering their Netherlands locations in favor of other European countries. The research report pointed to more than 1,500 job losses about eight years ago following Abbott and Merck Sharpe and Dohme closing facilities in that country. Between 2009 and 2014, Quantify said the Dutch market share in the European pharma industry plummeted from 3.3 percent in 2009 to 17 percent in 2014.

To help spur the resurgence of the Netherlands pharma industry, the Netherlands Foreign Investment Agency is hosting a landscape tour at the end of summer to showcase the country’s offerings. While the EMA is expected to become the core of the Netherlands biopharma industry, the NFIA said the country is home to facilities for more than 420 biopharmaceutical companies, such as AstraZenecaJanssen, MSD, Amgen and Teva, to name a few. The Netherlands Foreign Investment Agency pointed to the companies because they “rely on their Dutch operations for both R&D and distribution activities.”

But, it’s not just the large global pharma companies that have a home in Holland. The country is also home to a number of biopharmaceutical startups and scale-ups, like GalapagosGenmabPharming and uniQure.

Another company that will be relocating to the Netherlands is Gilead Sciences.  This new facility will be employing over 300 people. Other companies worth mentioning are GSK-Novartis, Merk and most well-known Clinical Research Organizations (CROs) have made the Netherlands their home.

For those interesting in working and living in Amsterdam, you should know that it is one of the countries with the highest taxes at a 52% income tax rate if you make over 55,000 euros per year (apparently they think this is good money). For a regular employee with benefits, your tax rate will be at a 42 %. Don’t expect to be making more than 55,000 euros a year unless you are a highly skilled employee or hold a managerial level position.

Tot Ziens!

Source:

Biospace

EMA

https://www.government.nl/latest/news/2018/04/23/the-european-medicines-agency-ema-and-the-netherlands-agree-on-seat-agreement

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CTCAE: Common Terminology Criteria for Adverse Events

The National Cancer Institute issued the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 on November 27, 2017.

So what is CTCAE and what is it used for?

The terminology NCI CTCAE is a descriptive terminology that can be used for the declaration of adverse events (AEs). A grade scale (or severity) is provided for each term.

The oncology community has a standard classification and severity grading scale for adverse events in cancer therapy clinical trials and this is what it is described in the CTCAE reference.

The SOC (System Organ Class or Organ Class) is the highest level of the hierarchy of the
MedDRA dictionary. It is identified by a physiological or anatomical classification, etiological or a result (ex: SOC investigations for laboratory results). The terms of the CTCAE are grouped together according to the MedDRA primary SOCs. Within each SOC, the terms are listed and accompanied a description of the severity (grade).






An adverse event is an unexpected sign, symptom or disease, unexpected (this includes
biological results), associated chronologically with the use of a treatment, a procedure,
to be connected to this treatment or procedure. An IE is a unique term representing an event
specifically used for the medical report and the scientific analyzes. Each term of the CTCAE is a
MedDRA LLT level term (Low Level Term, lowest level of the hierarchy).
Grades refer to the severity of AEs. The CTCAE is divided into 5 grades, each with
unique medical description for each term, based on the following main lines:
Grade 1: Light; asymptomatic or mild symptoms; diagnosis on clinical examination only; born
not requiring treatment
Grade 2: Moderate; requiring minimal, local or non-invasive treatment; interfering with activities instrumentalities of everyday life
Grade 3: Severe or medically significant but without immediate life-threatening;
indication of hospitalization or prolongation of hospitalization; invalidating; interfering with activities elementary of everyday life
Grade 4: Life-threatening; requiring emergency care
Grade 5: Death related to AE and it is not appropriate for some AEs and therefore is not an option.
MedDRA code CTCAE v5.0 Term Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Definition
10007515 Cardiac arrest Life-threatening
consequences; urgent
intervention indicated<
Death A disorder characterized by cessation of the pumping function of the heart.

CTCAE is still the formal reporting for AEs and grading dependent upon clinician judgement of medical significance.

A copy is located here: CTCAE version 5.0.

Sources:

https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5×11.pdf

Feature image: CTCAE-4 by Stefano Peruzzi (apple app)

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Clinical Programmer Available for Consultancy projects.

Clinical Programmer Available for consultancy projects – Medidata Rave Certified.

Rate: Negotiable

Hours: part time or full time

Contracts: 1099 or Corp-2-corps only.

Motto of the Month – Success

Success is the progressive realization of the worthy goal or ideal. – Earl Nightingale

I have been listening to motivational audios for over 2  years now, and this is TRUE FACTS! Never give up on your values, beliefs and morals.

A man/woman is what he / she thinks about all day long. Think about this too, All the hate in the fake news (a.k.a. communication channels whether radio, tv or internet) about racism,  gender or economic classes can affect you at your subconscious level and limit your potential for growth.

Success - Anayansi Van Der Berg

 

The real problem with people isn’t simply fear but conformity as we do what we see or are told to believe what we see or hear. GOD is within you.

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Vandaag is GDPR dag! GDPR is in place! Are you ready for it?

According to the EU General Data Protection Regulation (GDPR), which comes into effect today, May 25th, 2018, most companies will need to inform you of their privacy policy for processing and protecting your personal information and your privacy.

The General Data Protection Regulation (GDPR) is already in place, but many companies are not yet ready - more precisely, only 45% of organizations said they had a structured plan to comply with it.

A recent survey also reveals that 54% of large organizations (with more than 5,000 employees) are better prepared to deal with GDPR; in small ones, this index drops to 37%. And, only 24% of companies use external consulting to become compatible.

With this  Regulation, individuals have the right to request that their personal data be erased or transferred to another organization. This raises questions as to what tools and processes they will need to implement. For 48% of respondents, it is a challenge to find only personal data in their own banks. In these cases, compliance with the GDPR rules will be an even more serious task.

55% of organizations are not prepared for GDPR

For EU citizens and residents, this is a welcome law. But for US citizens and residents, they will continue to suffer identity theft and data privacy violations in the hands of the same companies the EU is trying to fined and control under this law. The Googles, the Facebooks, the Twitters and most social media will be scrutinized heavily after this day.

Who does the GDPR affect?
The GDPR not only applies to organizations located within the EU but it will also apply to organizations located outside of the EU if they offer goods or services to, or monitor the behavior of, EU data subjects. It applies to all companies processing and holding the personal data of data subjects residing in the European Union, regardless of the company’s location.

What are the penalties for non-compliance?
Organizations can be fined up to 4% of annual global turnover for breaching GDPR or €20 Million. This is the maximum fine that can be imposed for the most serious infringements e.g.not having sufficient customer consent to process data or violating the core of Privacy by Design concepts. There is a tiered approach to fines e.g. a company can be fined 2% for not having their records in order (article 28), not notifying the supervising authority and data subject about a breach or not conducting an impact assessment. It is important to note that these rules apply to both controllers and processors — meaning ‘clouds’ will not be exempt from GDPR enforcement.

Source:

https://www.eugdpr.org/

https://ec.europa.eu/commission/priorities/justice-and-fundamental-rights/data-protection/2018-reform-eu-data-protection-rules_en

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