Theorem Clinical Research

Ethics/Regulatory

EMA’s clinical trial data policy delayed until October

Thursday, July 10, 2014 12:53 PM

The management board of the EMA has postponed formal adoption of the policy on publication of clinical trial data until its Oct. 2 meeting. Further clarifications on wording and practical arrangements will be discussed by board members, who have confirmed their general support of the overall aim and objectives of the policy, including the more user-friendly amendments proposed by Guido Rasi, EMA executive director, that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.

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EFPIA launches IMI2—a $4.5B public-private healthcare partnership

Wednesday, July 9, 2014 12:09 PM

EFPIA has announced the launch of IMI2, the continuation of the successful partnership of industry and public bodies to tackle health needs. IMI is a public-private partnership (PPP) between the European Commission and EFPIA, the European Federation of Pharmaceutical Industries and Associations. The first phase of IMI (2008 to 2013) was established with a budget of $2.7 billion. IMI2 has been established under the E.U. framework program Horizon 2020 with an even bigger budget of $4.5 billion—bringing together the public and private sectors in the largest healthcare PPP in Europe.

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U.K. Prime Minister commissions independent antibiotics review

Wednesday, July 2, 2014 12:48 PM

U.K. Prime Minister David Cameron, along with the U.K. Department of Health, has commissioned a wide reaching independent review, led by economist Jim O’Neill and co-funded and hosted by medical research foundation the Wellcome Trust, to explore the economic issues surrounding antimicrobial resistance. Growing numbers of bacterial and viral infections are resistant to antimicrobial drugs, but no new classes of antibiotics have come on the market for more than 25 years.

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Massachusetts becomes 7th state to pass law allowing pharmacy substitution of interchangeable biosimilars

Friday, June 27, 2014 12:08 PM

By Ronald Rosenberg
CenterWatch Staff Writer

Massachusetts this week became the seventh state to allow for the substitution at the pharmacy of biosimilars deemed “interchangeable” with branded original drugs—legislation being enacted on a state-by-state basis.

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Patient-initiated Guidance for Industry for Duchenne submitted to FDA

Wednesday, June 25, 2014 01:51 PM

Parent Project Muscular Dystrophy (PPMD) and a broad coalition of stakeholders have submitted the first-ever patient advocacy-initiated draft guidance for a rare disease to the FDA to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.

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ACRP, European Center for Clinical Research Training collaborate

Thursday, June 19, 2014 01:45 PM

The Association of Clinical Research Professionals (ACRP) and the European Center for Clinical Research Training (ECCRT), a SynteractHCR company, have introduced the ECCRT/ACRP STAR Program, a comprehensive and collaborative clinical research training and development program being offered across Europe.

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ESMO welcomes the adoption of the Clinical Trials Regulation by the E.U.

Tuesday, June 17, 2014 11:06 AM

The European Society for Medical Oncology (ESMO) has welcomed the adoption of the Clinical Trials Regulation by the E.U.

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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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