A new recruitment opportunity added to the website - QA Manager, Charles River, France
Another recruitment opportunity added to the website - Quality Assurance Manager (part time), UCL Cancer Institute, London
This guidance specifies the technical requirements and the process of transmission of individual case safety reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the European Economic Area.
This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have. It provides an overview of the procedure to obtain scientific advice or protocol assistance and gives guidance to Applicants in preparing their request.
Document gives advice on sterile manufacturing processes for veterinary stem cell medicines The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) has approved today the first ever guidance at European Union (EU) level for stem cell-based medicines for veterinary use, in the form of a question-and-answer document prepared by the CVMP’s Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)
20th June 2017 FDA is announcing the availability of a draft guidance for industry entitled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11-- Questions and Answers.” The draft guidance provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under part 11 in clinical investigations of medical products.
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The EMA Board discussed the progress made regarding the development of the EU clinical trial portal and database. Due to technical difficulties with the development of the IT systems, the portals go-live date has been postponed.
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Management Board endorsement starts countdown for stakeholders to get ready for launch of improved system in November 2017 The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.
Key principles and working methodology established The European Medicines Agency (EMA) organised an information meeting yesterday with members of its Management Board and heads of the National Competent Authorities (NCAs) of the EU/EEA Member States. The goal was to start discussing how the work related to the evaluation and monitoring of medicines will be shared between Member States in view of the United Kingdom’s (UK) withdrawal from the European Union.
18 May 2017 | GENEVA - Some of the world’s largest funders of medical research and international non-governmental organizations today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.