Theorem Clinical Research

Ethics/Regulatory

Aspire IRB, Midlands IRB join WIRB-Copernicus Group

Monday, June 16, 2014 11:01 AM

Aspire IRB and Midlands IRB have joined the WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research.

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Latest AAHRPP accreditations include N.Y. State Department of Health

Thursday, June 12, 2014 01:40 PM

The Association for the Accreditation of Human Research Protection Programs has accredited three more organizations, including one of the nation's largest state health departments and India's national comprehensive cancer center. A nonprofit organization, AAHRPP provides accreditation for organizations that conduct or review human research and can demonstrate that their protections exceed the safeguards required by the U.S. government.

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EMA responds to concerns on its publication of clinical trial data policy

Thursday, June 12, 2014 01:36 PM

The EMA Management Board meeting will consider a draft policy on the publication of clinical trial data. The draft policy arises from the agency’s commitment to increase access to clinical trial data and has been shaped by the many comments received during the consultation phase.

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EFPIA calls for universal adherence to European regulatory framework

Wednesday, June 11, 2014 12:51 PM

EFPIA, the European Federation of Pharmaceutical Industries and Associations, is concerned about a decision by the Italian health authority to allow the reimbursement of off-label treatments for economic reasons when on-label alternatives are available. The organization calls on the European Commission to ensure member states adhere to the European regulatory framework and that financial considerations do not take precedence over regulatory decisions. 

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FDA launches openFDA to provide easier access to FDA public health datasets

Monday, June 2, 2014 01:19 PM

The FDA has launched openFDA, a new initiative designed to make it easier for web developers, researchers and the public to access large, important public health datasets collected by the agency.

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EMA welcomes publication of the Clinical Trials Regulation

Friday, May 30, 2014 01:38 PM

The EMA welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union (E.U.). This legislation will foster European competitiveness and innovative capacity, and facilitate swifter development of new medicines for patients. In addition to simplifying clinical trial approvals, the regulation foresees transparency on the conduct of trials in the European Economic Area, from the point of their authorization to the publication of the results of those clinical trials.

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WIRB-Copernicus Group launches oncology IRB to meet challenges of cancer research

Thursday, May 29, 2014 01:15 PM

By Ronald Rosenberg
CenterWatch Staff Writer

The WIRB-Copernicus Group (WCG), a large provider of regulatory and ethical review services for clinical research, has formed WCG Oncology, a new cancer-focused institutional review board, along with the WCG Oncology Expert Advisory Board, which includes James E. Rothman, Ph.D., the 2013 recipient of the Nobel Prize in Medicine and chairman of cell biology at Yale Medical School.  

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Ombudsman concerned by EMA policy change for clinical transparency

Wednesday, May 21, 2014 01:31 PM

In a letter to the EMA, the European Ombudsman, Emily O'Reilly, has expressed concern about a significant change of policy concerning clinical trial data transparency. The European Ombudsman investigates complaints about maladministration in the E.U. institutions and bodies.

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EMA, FDA release joint proposal for Gaucher research

Friday, May 16, 2014 12:49 PM

The EMA and the FDA have released a draft joint proposal to facilitate the clinical investigation of new medicines for the treatment of Gaucher disease in children. The document is released for public consultation until Aug. 31.

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FDA approves WuXi’s manufacture of ibalizumab in China for use under a U.S. IND

Wednesday, May 7, 2014 01:32 PM

The FDA has approved the first batch of the ibalizumab (TMB-355) drug substance and sterile drug product, manufactured at WuXi PharmaTech's biologics facilities and developed by TaiMed Biologics for the treatment of HIV/AIDS infection. 

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