Monthly Archives: February 2018

The regulatory landscape for medical devices in Europe is undergoing some major changes. Published in May 2017, the new European Medical Device Regulation (MDR) (Regulation [EU] 2017/745) and In Vitro Diagnostics Regulation (IVDR) (Regulation [EU] 2017/746) is gradually replacing the Medical Devices Directive and the Implantable Medical Devices Directive in the European market. Although theRead more

DURHAM, N.C., FEBRUARY 16, 2018 — Biotech innovators exploring new outsourcing models to develop hematological cancer drugs should attend our February 20 webinar. Presented by Luke Gill, Vice President Oncology, Clinical Development Services, and Colin Hayward, Chief Medical Officer, Immuno-Gene Therapeutics in Hematological Cancers: How Science Drives Study Strategy will cover the latest research trends in immuno-oncology and gene therapy andRead more

DURHAM, N.C., February 16, 2018 — Are expedited approvals of new drugs occurring at the expense of innovation? Nach Davé, Vice President of Global Regulatory Affairs at Premier Research, will explore the subject at Outsourcing in Clinical Trials West Coast 2018, February 21 in Burlingame, California. In his presentation, Faster Approvals but Less Innovation: TrendRead more

Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the protection of study participants and the integrity of clinical trial data. The recent update ofRead more

No doubt you’ve heard much about Meltdown and Spectre, major security defects in the microprocessors that underpin nearly all of the world’s computers. Hackers, the world learned in early January, can exploit these defects to steal the entire memory contents of PCs, mobile devices, and the servers that make up cloud computing networks. That putsRead more

DURHAM, N.C., February 6, 2018 — Two Premier Research medical device experts will examine the impact of upcoming changes to European medical device regulations at Outsourcing in Clinical Trials Medical Devices Europe 2018. Joanne Emmett, Vice President for Medical Device and Diagnostics, and Janet Kube, Director, Project Management, will discuss the new EU Medical DeviceRead more

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