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Anne Juliana Gonzaga became a Servant of Mary following the death of her husband, Ferdinand II, Archduke of Austria in 1595, after receiving a vision of the Madonna, to whom her parents had prayed to cure her of a childhood illness?
In the Tower Hamlets in East London imams known as the a€?Tower Hamlets Talibana€? issue death threats to unveiled women, and gays are attacked by gangs of young Muslim men. Germany is another example of European governments opposing their native populations trying to resist Islamization. The Orwellian Islam is Peace Campaign - Muslims as victims, who are extending a hand in Peacea„?, fight Terrorisma„?, and prevent a backlash of Islamophobiaa„?. Mordechai Kedar and David Yerushalmi peer reviewed report in June 2011 concluded a€?80% of U.S. When Molly Norris, the Seattle Weeklya€™s popular cartoonist who started Facebooka€™s a€?Everybody Draw Mohammed Daya€?, she did it as a joke. Sometimes people quote a single Koranic verse, or part of one, to prove Islam is this or that. Obama told NASA chief to help Muslims feel good about their historic contribution to science, math, and engineering. In April 2012 the State Department barred inspection of Muslim Brotherhood delegation when they came to visit government officials and think tanks in the United States.
Obamaa€™s DOJ sued a Chicago-area school district for not allowing a Muslim teacher at a middle School to take a month off to make the hajj, the pilgrimage to Mecca. The free on line version of Qutba€™s In the Shade of the Qura€™an includes a book review U.S. Ejected from Arab Festival 2009 in Dearborn for asking a question at a booth that said a€?Got questions? Arrested at Arab Festival 2010 for having a public conversation about Christianity with Muslims while standing outside the Free Speech Areaa„?, according to the mayor of Dearborn. In July, 2011 Andrew Breivika€™s attack in Norway saturated the news, and was erroneously blamed on Spencer and other counterjihadists mentioned in his Manifesto. Here is evidence that Qatar is arguably the preeminent sponsor of terror in the world today.
During the same time in the 1940s, some 900,000 Jews left behind $300 billion in assets when they were forced to flee for their lives from Muslim countries.
In just 60 years almost a million Jews whose communities stretch back up to 3,000 years have been 'ethnically cleansed' from 10 Arab countries. For tactical reasons, Jordan, which is a sovereign state with defined borders, cannot raise claims to Haifa and Jaffa, while as a Palestinian, I can undoubtedly demand Haifa, Jaffa, Beer-Sheva and Jerusalem.
Vanderbilt Muslim professor admits Islamic law mandates death for homosexuals, but says no country in the world has sharia law. Sweden: Iranian Christian ordered deported to Iran despite facing execution for apostasy there. And we should recall how other people behave when subjected to military occupation or political abuse. List of criminal prosecutions and convictions, and other Free Speecha„? violations in Western countries for reporting true things about Islam.
Here are many influential orgs & people, both Muslim and non-Muslim that want to criminalize free speech about Islam worldwide, including in the USA. Dispatches - Undercover Mosque - British Mosques (2006).A  Watch a few minutes and you get the idea. 5)Mordechai Kedar and David Yerushalmi peer reviewed report in June 2011 concluded a€?80% of U.S. The ICH Steering Committee (SC) will meet in Fukuoka, Japan from 6 to 11 June to discuss ongoing harmonisation activities. The IPEC Federation (International Pharmaceutical Excipients Council) has published a three-page position paper concerning the risk-based approach of the EU Guidelines following the principles of Quality Risk Management according to ICH Q9. For many years now, discussions have been ongoing as to whether it is possible to include non-distillation technologies as a method for the production of Water for Injections (WFI).
The currently valid version of the EU GMP Guide  Annex 15 “Qualification and Validation” from 2001 will finally be replaced by 1 October 2015.
With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. In a highly acclaimed talk held during our GMP Symposium, Richard Denk elucidated the risk factors for contamination and the influence of highly active substances. The European Medicines Agency (EMA) has released a Concept Paper on the Revision of Annex 1 of the Guidelines on Good Manufacturing Practice – Manufacture of Sterile Medicinal Products which addresses the need to update Annex 1 of the European GMP Guide.
New versions of Chapter 3 (Premises and Equipment) and Chapter 5 (Production) have been published providing transitional arrangements for toxicological evaluation. FDA Center for Drug Evaluation and Research (CDER) launched an Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative. The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2014 and now enters the implementation period (Step 5).
The US Food and Drug Administration (FDA) has just released a list of all new and revised draft guidances it plans to release in 2015. The ICH Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal on November 8–13, 2014. Before the end of the year the European Commission has published the “Commission Delegated Regulation (EU) No. The EMA has published the final version of the „Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA. Officials of Australia and New Zealand have confirmed the plan to stop the development of the joint regulatory authority ANZTPA. This month representatives of the FDA have met with their cross-agency team from the EMA, the European Commission and GMP experts form European Union Member States in London, in order to make progress on mutual reliance on GMP inspections.
ISPE released its Drug Shortages Prevention Plan during the 2014 Annual Meeting in Las Vegas, Nevada.
This month the EMA released a “Reflection paper in the requirements for selection and justification of starting materials for the manufacture of chemical active substances”. On 21 October 2014, the FDA released the final version of its Guidance for Industry entitled „Circumstances that constitute delaying, limiting, or refusing a drug inspection”. The ICH Steering Committee has endorsed the final concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. The use of products with non-declared pharmacological activity or “other illegal medicines”, often from uncontrolled sources but also purchased from the legal market, is still a major problem within Europe. From 10-11 September 2014, the second symposium on combating counterfeits and other illegal medicines took place at EDQM.
The Active Pharmaceutical Ingredients Committee, APIC, has recently published a comprehensive How to do Document regarding electronic Common Technical Documents.
The European Commission has published a revised version of Part II of the EU GMP Guide – Basic Requirements for Active Substances used as Starting Materials. The EU’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators PilotExternal link icon (IGDRP). The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk has reached Step 4 of the ICH process and is now entering the implementation period (Step 5). FDAs Center for Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances.


Last week the FDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013.
EU regulators have unveiled a new logo which will appear on the websites of all authorised online pharmacies known to provide authentic medicines. The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM). EMA has published the long awaited Qualified Person (QP) declaration template and accompanying guidance concerning GMP compliance of API manufacture. The FDA, in partnership with other federal and international agencies, took action last week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. As previously reported, the FDA is working on a system that will help to identify and trace dangerous drugs that are counterfeit, stolen or tainted throughout the whole supply chain. This month, the WHO has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – non-sterile process validation.
The European Commission has published the final version of Chapter 6 Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use on April 3, 2014. The EMA has published the final version of the long awaited Guideline on Process Validation “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” on February 24, 2014.
The FDA has published a Draft Guideline for Industry entitled Analytical Procedures and Methods Validation for Drugs and Biologics. The FDA initiates the Secure Supply Chain Pilot Program to enhance the security of imported drugs.
The CFDA has announced the adoption of the draft amendment to the Regulations for the Supervision and Administration of Medical Devices at the executive meeting of the State Council on February 12, 2014. As announced by the Swiss Regulatory Authority Swissmedic, a Memorandum of Understanding in the area of therapeutic products was signed with the Korean Ministry for Food and Drug Safety (MFDS). Shortly after the FDA notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products due to particularly serious GMP deficiencies, health agencies in Europe are evaluating the FDA inspection findings to assess if these deviations from GMP have any implication on medicines on the European market. The Health Ministry of India has constituted a sub-committee to prepare guidelines regulating the transportation of drugs in the country.
Early this month, the China Food and Drug Administration (CFDA) issued an announcement on the implementation of the Good Manufacturing Practice for Drugs (2010 Revision) for sterile pharmaceutical products. According to pharmabiz, the government of India is planning a revision of its GMP guidelines – Schedule M – and considers making them on par with the WHO-GMP standards.
The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) published the results of their last meeting in Osaka: ICH Reviews Future ICH Topics and Its Organisation Towards Increased Engagement Globally. You must have JavaScript enabled in your browser to utilize the functionality of this website. In 2008, one of the Church of Englanda€™s most senior bishops, Pakistani-born Michael Nazir-Ali, warned that Islamic extremists had created a€?no-goa€? areas across Britain too dangerous for non-Muslims to enter.
This isna€™t just a scandal, ita€™s a surrender a€“ a cultural and societal collapse unprecedented in human history.
Between 2002 and 2007 there were over 1,400 acid attacks just in Bangladesh, often resulting in blindness.
Like when Obama cherry picked 2 violent intolerant Koranic verses and took them out of context to supposedly demonstrate Islamic Tolerancea„? in his speech to the Muslim world in 2009 at Al-Azhar University. They forced the school district to give the teacher $75,000 in lost back pay, compensatory damages and attorneysa€™ fees. But later in prison he reveals himself a nazi who wanted to destroy the counter-jihad movement.
Watch this video of a black South African Parliament member explaining why Israel is not an apartheid state. These refugees outnumber the Palestinian refugees two to one, but their narrative has all but been ignored. The creation of a Palestinian state is only a means for continuing our struggle against the state of Israel for our Arab unity. The report was developed during a Member State Meeting on SSFFC in October 2014 in Geneva, Switzerland.
Food and Drug Administration (FDA) has published their yearly list of new and revised draft guidances CDER is planning to publish in 2015. Food and Drug Administration (FDA) issued five draft documents related to drug compounding and repackaging to help entities in complying with important health provisions. The EMA has published a revised version of the guideline "Guideline on similar biological medicinal products". The report has been presented in a revised format, following comments from a stakeholder focus group. Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems. Representatives from forensic and customs laboratories, national medicines and food authorities, enforcement groups and the European Commission were invited to shed light on the problem of falsification of medicines. According to the EC this became necessary due to changes in various Annexes of the GMP Guide. FDA and the EMA (European Medicines Agency) announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. Is the FBI admitting there are too many possible Muslim assassins who heard about the fatwa? Then 2 days later in front of a Dearborn mosque a Muslim was charged with Nine Counts of Attempted Murder for trying to kill street preachers with his car outside the Islamic Center of America, where mosque security said they knew the man and he was provoked.
Around the same time as the attack this story about far more Islamic terror attacks killing far more civilians during Ramadan went virtually unreported. In reality today there is no difference between Jordanians, Palestinians, Syrians and Lebanese.
They have the suicide part down, because they are now practicing a campaign of self-immolationa€”which, being the incendiary equivalent of a hunger strike, is about as far from suicide bombing as can be conceived. Islamic supremacists do not want any seat on the bus, they want to sit at the front so to speak, or if possible have their own bathrooms, swimming pools, beaches, or sharia compliant prison toilets, public buses and taxis, and an exception to the ban on Olympic blue belt judo headgear. The draft documents apply to outsourcing facilities, federal facilities, pharmacies and physicians. The regulation was issued on 25 November 2014 in the Official Journal of the European Union and has entered into force on 15 December 2014.
In Sweden whole patches of the city of MalmA¶ a€“ which is more than twenty-five percent Muslim a€“ are no-go zones. This is something a Muslim only has to do only once in a lifetime, if able, and since the Islamic calendar is lunar with only 355 days, she could have waited a few years until she could go during summer vacation. He lead Muslim prayers on Capitol Hill in 2002 where a congressmana€™s chief of staff, CAIR founder Nihad Awad, and former CAIR employee Randall Royer who is serving 20 years on terror related charges, were present. Muise successfully challenged the City of Dearborna€™s restriction on Christian Pastor George Saiega€™s freedom of speech elsewhere at the Festival.
You can verify every attack in news reports with internet searches using the details in the list, and the site is even willing to supply a source for a specific attack to serious inquirers. The Arabs claim 650,000-750,000 up to a million refugees, while the UN Acting Mediator in October, 1948 set it at 472,000, of which 360,000 required aid. Some 50 percent of the Jewish population descend from these refugees and are now full citizens. During the time of the British Mandate a€” from 1922 to 1948 a€” the Jews called where they lived Palestine.


And where is that long list of Palestinian Christian suicide bombers youa€™ve been keeping in your desk? Not only the new principles of ICH Q8, Q9, Q10 and Q11 constituted a new regulatory environment but also a continuous updating of Chapters of Part I of the EU GMP Guide or Annex 11 (computerised systems). Awad holds conferences with people like Nancy Pelosi and Sheik Qaradawi, and met with President Bush 2, see photos. Another important document to be mentioned in connection with the new Annex 15 is the EMA guidance on process validation.
Of all the [40 million +] refugees, only these [descendants of 360,000] Arabs have demanded the right of return. They read the Palestine Post (now the Jerusalem Post.) As the Palestine Brigade, they fought in the British Army in World War 2. THESE VERY SAME ENFORCEMENT AGENCIES, WHO HAVE SWORN TO PROTECT AND SERVE, OUR COUNTRY, AND CITIZENS ,ARE BUT SOME, OF THE CORRUPT,GREEDY TRAITORS .ENGAGED IN THE TYRANNY AND TORTURE.
1,400 British non-Muslim children were gang-raped and brutalized by Muslims in the British city of Rotherham, in accord with the Qura€™anic allowance for the sexual enslavement of infidel women that the Islamic State has pointed to in order to justify its exploitation of captive Yazidi and Christian women. Where, for that matter, are the Pakistani, Iraqi, or Egyptian suicide bombers killing for the glory of Christ? These Christian communities are regularly attacked by suicidal jihadistsa€”why dona€™t they respond with the same sort of violence? The school district has moved to a biometric identification program, saying students will no longer have to use an ID card to buy lunch.A  BIOMETRICS TO TRACK YOUR KIDS!!!!!i»?i»?A TARGETED INDIVIDUALS, THE GREEDY CRIMINALS ARE NOW CONDONING THEIR TECH!
Paul Weindling, history of medicine professor at Oxford Brookes University, describes his search for the lost victims of Nazi experiments. The chairman of the board at ESL a€” then proprietor of the desert wasteland in Nevada known as a€?Area 51a€? a€” was William Perry, who would be appointed secretary of defense several years later. EUCACH.ORG PanelIn a 2-hour wide-ranging Panel with Alfred Lambremont Webre on the Transhumanist Agenda, Magnus Olsson, Dr. Henning Witte, and Melanie Vritschan, three experts from the European Coalition Against Covert Harassment, revealed recent technological advances in human robotization and nano implant technologies, and an acceleration of what Melanie Vritschan characterized as a a€?global enslavement programa€?.Shift from electromagnetic to scalar wavesThese technologies have now shifted from electromagnetic wave to scalar waves and use super quantum computers in the quantum cloud to control a€?pipesa€? a reference to the brains of humans that have been taken over via DNA, via implants that can be breathed can breach the blood-brain barrier and then controlled via scalar waved on a super-grid. Eventually, such 'subvocal speech' systems could be used in spacesuits, in noisy places like airport towers to capture air-traffic controller commands, or even in traditional voice-recognition programs to increase accuracy, according to NASA scientists."What is analyzed is silent, or sub auditory, speech, such as when a person silently reads or talks to himself," said Chuck Jorgensen, a scientist whose team is developing silent, subvocal speech recognition at NASA Ames Research Center in California's Silicon Valley.
We numbered the columns and rows, and we could identify each letter with a pair of single-digit numbers," Jorgensen said.
People in noisy conditions could use the system when privacy is needed, such as during telephone conversations on buses or trains, according to scientists."An expanded muscle-control system could help injured astronauts control machines.
If an astronaut is suffering from muscle weakness due to a long stint in microgravity, the astronaut could send signals to software that would assist with landings on Mars or the Earth, for example," Jorgensen explained.
These are processed to remove noise, and then we process them to see useful parts of the signals to show one word from another," Jorgensen said.After the signals are amplified, computer software 'reads' the signals to recognize each word and sound.
Our Research and Development Division has been in contact with the Federal Bureau of Prisons, the California Department of Corrections, the Texas Department of Public Safety, and the Massachusetts Department of Correction to run limited trials of the 2020 neural chip implant.
We have established representatives of our interests in both management and institutional level positions within these departments. Federal regulations do not yet permit testing of implants on prisoners, but we have entered nto contractual agreements with privatized health care professionals and specified correctional personnel to do limited testing of our products.
We need, however, to expand our testing to research how effective the 2020 neural chip implant performs in those identified as the most aggressive in our society. In California, several prisoners were identified as members of the security threat group, EME, or Mexican Mafia. They were brought to the health services unit at Pelican Bay and tranquilized with advanced sedatives developed by our Cambridge,Massachussetts laboratories. The results of implants on 8 prisoners yielded the following results: a€?Implants served as surveillance monitoring device for threat group activity. However, during that period substantial data was gathered by our research and development team which suggests that the implants exceed expected results. One of the major concerns of Security and the R & D team was that the test subject would discover the chemial imbalance during the initial adjustment period and the test would have to be scurbbed. However, due to advanced technological developments in the sedatives administered, the 48 hour adjustment period can be attributed t prescription medication given to the test subjects after the implant procedure. One of the concerns raised by R & D was the cause of the bleeding and how to eliminate that problem.
Unexplained bleeding might cause the subject to inquire further about his "routine" visit to the infirmary or health care facility. Security officials now know several strategies employed by the EME that facilitate the transmission of illegal drugs and weapons into their correctional facilities. One intelligence officier remarked that while they cannot use the informaiton that have in a court of law that they now know who to watch and what outside "connections" they have.
The prison at Soledad is now considering transferring three subjects to Vacaville wher we have ongoing implant reserach.
Our technicians have promised that they can do three 2020 neural chip implants in less than an hour. Soledad officials hope to collect information from the trio to bring a 14 month investigation into drug trafficking by correctional officers to a close. Essentially, the implants make the unsuspecting prisoner a walking-talking recorder of every event he comes into contact with. There are only five intelligence officers and the Commisoner of Corrections who actually know the full scope of the implant testing. In Massachusetts, the Department of Corrections has already entered into high level discussion about releasing certain offenders to the community with the 2020 neural chip implants. Our people are not altogether against the idea, however, attorneys for Intelli-Connection have advised against implant technology outside strick control settings. While we have a strong lobby in the Congress and various state legislatures favoring our product, we must proceed with the utmost caution on uncontrolled use of the 2020 neural chip. If the chip were discovered in use not authorized by law and the procedure traced to us we could not endure for long the resulting publicity and liability payments. Massachusetts officials have developed an intelligence branch from their Fugitive Task Force Squad that would do limited test runs under tight controls with the pre-release subjects.
Correctons officials have dubbed these poetnetial test subjects "the insurance group." (the name derives from the concept that the 2020 implant insures compliance with the law and allows officials to detect misconduct or violations without question) A retired police detective from Charlestown, Massachusetts, now with the intelligence unit has asked us to consider using the 2020 neural chip on hard core felons suspected of bank and armored car robbery. He stated, "Charlestown would never be the same, we'd finally know what was happening before they knew what was happening." We will continue to explore community uses of the 2020 chip, but our company rep will be attached to all law enforcement operations with an extraction crrew that can be on-site in 2 hours from anywhere at anytime. We have an Intelli-Connection discussion group who is meeting with the Director of Security at Florence, Colorado's federal super maximum security unit. The initial discussions with the Director have been promising and we hope to have an R & D unit at this important facilitly within the next six months. Napolitano insisted that the department was not planning on engaging in any form of ideological profiling. I will tell him face-to-face that we honor veterans at DHS and employ thousands across the department, up to and including the Deputy Secretary," Ms. Steve Buyer of Indiana, the ranking Republican on the House Committee on Veterans' Affairs, called it "inconceivable" that the Obama administration would categorize veterans as a potential threat.




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