Ethics/Regulatory

Domestic Research Enhancement Act of 2017 endorsed by many

Tuesday, April 11, 2017

The Domestic Research Enhancement Act of 2017 (H.R. 1234), which modernizes the R&D tax credit to recognize the essential role contract research now plays in the development of new pharmaceuticals, biologics and medical devices, has been introduced by Rep. Pat Meehan (R-PA) and co-sponsors Rep. George Holding (R-NC) and G.K. Butterfield (D-NC).

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Science march planned for April 22

Tuesday, April 11, 2017

On Saturday, April 22, the March for Science will take place in more than 400 cities across the globe to celebrate the many scientific advances that have improved the health and well-being of people worldwide. Research!America will be on the ground participating in the Washington, D.C. event, and some of the satellite marches in Los Angeles, California; Oklahoma City, Oklahoma; and Salt Lake City, Utah. 

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HealthCarePoint’s mRSI initiative reaches 10-year milestone

Wednesday, April 5, 2017

HealthCarePoint (HCP) has announced that the modified Rankin Scale (mRS) standards are now available to healthcare and clinical research professionals on every continent and in over 12 languages through the BlueCloud Education Network. The achievement marks a 10-year milestone for the company, which is working to standardize healthcare training and certification for healthcare professionals internationally. 

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KCR’s ethical assessment of clinical trials following EU CTR implementation

Thursday, March 30, 2017

Since the publication of the EU Clinical Trial Regulation (CTR) 536/2014 in the Official Journal, a new scheme of Clinical Trial Application (CTA) has been developed. Although certain rules for timelines, coordinated assessment and IT infrastructure are detailed, it remains up to each Member State how to organize ethical assessment and the cooperation of the Ethics Committee(s) (ECs) with National Competent Authorities (NCAs). KCR’s Anna Kubik, director Regulatory Affairs, who is a speaker at the DIA EuroMeeting this year, presented an overview of the current status focusing on the development of local requirements in terms of ethical assessment as well as proposed schemes respectively.

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