news roundup
Guido Rasi, Executive Director of the EMA, has conceded that the planned exit of the U.K. from the European Union (EU) could have a major impact on the activities of the EMA.
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Are Local IRBs Really Necessary?
Live Webinar: Tuesday, February 28 at 1:00pm EST
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Moffitt Cancer Center has chosen cryogenic logistics company, Cryoport to provide support for its immunology program, cancer research, therapy programs and lab moves.
The AAHRPP announced that it has accredited four research organizations which include two academic medical centers, a research university and a premier, globally recognized cancer center.
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The Evolution of Regulatory Affairs
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Articles
Activities associated with site selection, study start-up, and site activation also pose challenges and company practices contribute to inefficiencies in these areas.
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Pediatric Oncology Trials: Changes on the Horizon
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The purpose of the CDISC Glossary is also to serve the community of clinical researchers by selecting and defining terms pertaining to clinical research, particularly eClinical investigations, sponsored by the pharmaceutical industry or a federal agency.
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Blog Posts
Initially, the network, known as ERN-LUNG, will aim to create an infrastructure to promote research in the different sub-themes of rare respiratory diseases that it is focusing on.
Title VIII of FDAAA has passed final review, and will be in effect on January 18, 2017. Failure to comply could cost drug trial sponsors tens of thousands of dollars a day.
Not only is implementing CDISC standards an industry best practice, it is now an FDA requirement for NDAs, ANDAs, BLAs, and DMFs on studies that start after December 17, 2016.
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