Ethics/Regulatory

URAC launches revised Case Management Accreditation program

Wednesday, September 11, 2013 01:48 PM

URAC has launched its enhanced Case Management Accreditation Standards and Measures, with an optional Transitions of Care Designation. URAC’s Case Management Accreditation program allows for the application of case management standards across all care settings, helping organizations demonstrate outcomes-based, patient-centered, high-value quality care.

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EFPIA responds to EMA draft policy on access to clinical trial data

Wednesday, September 11, 2013 01:20 PM

EFPIA, representing the research-based pharmaceutical industry in Europe with a membership of 33 national associations and 40 pharmaceutical companies, has concerns about the EMA draft policy (0070) on publication and access to clinical trial data, saying it carries negative implications for public health in its failure to adequately protect the interests of patients and the research from which they benefit.

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EMA now accepting Safe-BioPharma digital signatures on eSubmissions

Friday, September 6, 2013 02:53 PM

Beginning this month, SAFE-BioPharma digital signatures will be accepted by the European Medicines Agency (EMA).  

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John Hopkins study suggests neurologists unaware of drug risks

Friday, August 16, 2013 10:41 AM

A study by Johns Hopkins researchers shows a fifth of U.S. neurologists appear unaware of serious drug safety risks associated with various anti-epilepsy drugs, potentially jeopardizing the health of patients who could be just as effectively treated with safer alternative medications.

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Industry associations support FDA Safety Over Sequestration Act

Wednesday, August 7, 2013 11:45 AM

Senator Mark Pryor, chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, and Sens. Roy Blunt, Daniel Coats, Al Franken and Jerry Moran last week introduced S. 1413 to exempt future FDA user fees from sequestration. A similar bill, H.R. 2725, was introduced in the U.S. House of Representatives earlier this month by Representatives Leonard Lance, Anna Eshoo, Mike Rogers and Doris Matsui.

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PhRMA endorses FDA Safety Over Sequestration Act

Monday, July 29, 2013 11:28 AM

The Pharmaceutical Research and Manufacturers of America (PhRMA) has endorsed the FDA Safety Over Sequestration Act of 2013. PhRMA represents U.S. biopharmaceutical research and biotechnology companies devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives.

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EFPIA, PhRMA release joint principles for responsible data sharing

Wednesday, July 24, 2013 01:41 PM

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have endorsed joint “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”

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Kantara Initiative, SAFE-Biopharma support NSTIC principles

Wednesday, July 3, 2013 10:41 AM

The Kantara Initiative, which helps organizations establish verified trust in use of digital identities for business and government services, and SAFE-Biopharma, which provides a global digital identity and digital signature standard for the life sciences, have pledged to adopt the four principles of the National Strategy for Trusted Identities in Cyberspace (NSTIC), the White House initiative to improve the privacy, security and convenience of sensitive online transactions.

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WIRB-Copernicus Group, UL Quality, Compliance and Learning partner

Friday, June 28, 2013 01:50 PM

The WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for human research, has partnered with UL Quality, Compliance and Learning (formerly EduNeering), a technology-driven compliance learning solutions company, to bring educational opportunities to clinical research professionals.

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AAHRPP, ViS Research Institute collaborate

Wednesday, June 26, 2013 02:51 PM

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) and the ViS Research Institute have allied to protect research participants by providing easy access to information on the quality and standards of organizations that conduct clinical trials.

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