A roundup of links on the EMA relocation decision can be found here.
The Asia QA Forum is a confederation of QA societies in Japan, Korea, China, Taiwan, Thailand, India, Malaysia and Singapore. The Forum arranges a conference every two years - RQA was invited to the 2017 Asia QA Forum 3rd International Conference in Beijing, China. On day one of the Forum Conference, on 7th September 2017, the Chinese Society of Quality Assurance (CSQA) and the Research Quality Association (RQA) signed a Collaboration Agreement that recognises the importance of mutual contribution to both parties, the industry and society. At a luncheon organised by the Asia QA Forum Council, the Research Quality Association was invited to speak in support of its application to become an Associate Member of the Asia QA Forum. Following a brief presentation, by Anthony Wilkinson, introducing the RQA and outlining what the Association could contribute to the Asia QA Forum, the Council unanimously agreed to approve RQA’s application. Accordingly, the Research Quality Association has been formally accepted as an Associate Member of the Asia QA Forum.
A new recruitment opportunity added to the website - Quality Assurance Manager at the Liverpool Experimental Cancer Medicine Centre (LECMC)
This is the first revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’. It extends the existing EU guidance to address first-in-human (FIH) and early phase clinical trials (CTs) with integrated protocols. The revision is intended to further assist stakeholders in the transition from non-clinical to early clinical development and in identifying factors influencing risk for new investigational medicinal products (IMPs).
A new recruitment opportunity added to the website - QA Manager, Charles River, France
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.
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.