RAPS Launches Global Compensation Survey of Regulatory Professionals

May 23, 2018

APS has launched its biennial survey of healthcare product regulatory professionals around the world, the Global Compensation & Scope of Practice Survey. It is the most comprehensive survey of regulatory professionals’ compensation, education, professional experience, demographics and work responsibilities. The survey is open to anyone involved in healthcare product regulation or compliance, including those who work in industry, government, law, research, consulting or any other relevant areas. The 2018 survey will close after 18 May. “RAPS has been conducting this research for more than 20 years, and it has been invaluable in improving understanding of the regulatory profession and its ...

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Novartis general counsel to step down after payments to Trump’s lawyer

May 22, 2018

Novartis AG’s top lawyer became the first executive to take the fall for the controversial $1.2 million in payments he helped arrange to President Trump’s attorney, as the drugmaker tries to contain the furor from last week’s revelation. Felix Ehrat, who along with former chief executive Joe Jimenez signed the agreement with a consulting firm led by lawyer Michael Cohen, will step down after seven years as Novartis’ general counsel, the Basel, Switzerland-based company said Wednesday in a statement. In an interview with Bloomberg, Jimenez said Cohen told him he had left Trump’s organization and stopped working for the president ...

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NovoEight® maintains potency when stored at 40ºC offering people with haemophilia A increased flexibility in their daily lives

May 22, 2018

A new long term stability study has shown that haemophilia A treatment NovoEight® (turoctocog alfa) remains potent after three months exposure to temperatures of 40ºC. The results were presented today at the WFH 2018 World Congress in Glasgow, UK. Treatment storage issues, especially the need for refrigeration, have been shown to be a common problem reported by people with haemophilia A. A portability study recently published in Patient Preference and Adherence found that most people are restricted in their personal activities, particularly travel and sports, due to temperature storage issues. If efficacy and safety are unaffected, storage flexibility was shown to be a ...

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groninger turns visions into reality at ACHEMA

May 22, 2018

The requirements are clearly defined: Pharma and Healthcare machine concepts for large and small factories of the future need to be readily available, flexible when it comes to processing variation, and modular in design. The vision cherished by traditional special engineering companies of tailoring production to suit their customer’s specific requirements is now reality. This is demonstrated by five “Business Line” machine range exhibits on Booth G72, Hall 3.1 at ACHEMA. The Ready Engineered concept is used across the groninger product portfolio to offer customers the desired flexibility while maintaining quality and safety. At groninger, Ready Engineered stands for the ...

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Robocath demonstrates safety and efficacy of its R-OneTM medical robotic platform

May 22, 2018

100 percent technical success and no Major Adverse Cardiac Events (MACE) scored in first pre-clinical randomized trial Robocath, a company that designs, develops and commercializes cardiovascular robotic systems for the treatment of vascular diseases, announces today during the EuroPCR congress that its first robotic solution, R-OneTM, met all its primary efficacy and safety endpoints in the first pre-clinical study. The prospective, randomized, controlled, multi-operator study evaluated the efficacity and safety of the robotic system compared to a manual procedure. Results showed that there was no significant difference between the procedures for all the primary endpoints and that R-OneTM achieved: •     100% ...

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